Prospect: A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer
Sponsor
Bavarian Nordic (Industry)
Overall Status
Completed
CT.gov ID
NCT01322490
Collaborator
(none)
1,297
220
3
72.6
5.9
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
BNIT-PRV-301 is a randomized, placebo-controlled, multi-center, global Phase 3 efficacy trial of PROSTVAC in men with asymptomatic or minimally symptomatic, metastatic, castrate-resistant prostate cancer. It is a 3-arm study and will evaluate overall survival in two separate comparisons, PROSTVAC plus adjuvant dose GM-CSF versus controls, and PROSTVAC without GM-CSF versus controls.
Patients will be randomized with equal probability into one of three double-blind arms. The intended interventions for randomized patients are:
-
(Arm V+G) PROSTVAC-V/F plus adjuvant dose GM-CSF
-
(Arm V) PROSTVAC-V/F plus GM-CSF placebo
-
(Arm P) Double placebo
Study Design
Study Type:
Interventional
Actual Enrollment
:
1297 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer
Actual Study Start Date
:
Nov 28, 2011
Actual Primary Completion Date
:
Sep 25, 2017
Actual Study Completion Date
:
Dec 15, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PROSTVAC-V/F-TRICOM + GM-CSF PROSTVAC-V-TRICOM PROSTVAC-F-TRICOM GM-CSF |
Biological: PROSTVAC-V
Biological: PROSTVAC-F
Drug: GM-CSF
|
| Experimental: PROSTVAC-V/F-TRICOM + GM-CSF placebo PROSTVAC-V-TRICOM PROSTVAC-F-TRICOM GM-CSF placebo |
Biological: PROSTVAC-V
Biological: PROSTVAC-F
Other: GM-CSF Placebo
|
| Placebo Comparator: Placebo Control PROSTVAC V/F Placebo + GM-CSF Placebo |
Other: GM-CSF Placebo
Biological: Placebo
PROSTVAC V/F Placebo
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [Randomization through the date of death due to any cause. Subjects were followed up for approximately 6 years from the first subject randomized to the completion of the study.]
The time between the date of randomization and the date of death due to any cause. Subjects who did not experience death or the competing events of "definite" loss to follow-up or withdrawal of consent were right censored at the date of last contact. OS was calculated using the formula: OS = Date of death/competing event/censoring - date of randomization + 1.
Secondary Outcome Measures
- Number of Subjects Alive Without Event at 6 Months [Randomization through Week 25/End of Treatment visit.]
A binary assessment that was performed for the 6-months timepoint for the categories of radiographic progression, pain progression, initiation of chemotherapy or death. Subjects without an event prior to 6-months were evaluated at 6-months. Subjects without event by 6-months and were not evaluated at 6-months were assumed to have had an event and analyzed as such. Progression events were defined as: (1) Two new lesions on bone scan, new metastases on CT scans, or an increased size of nodal lesions per RECIST 1.1. Bone or CT scans occurring prior to calendar month 6 were used to determine radiographic progression. (2) Introduction of scheduled opioid narcotics for cancer-related pain control. (3) Initiation of chemotherapy for prostate cancer was assessed as collected on progression forms as well as in cancer treatment and concomitant medications logs. (4) Death.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Men, ≥18years of age with documented asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
Documented progressive disease post surgical castration or during androgen suppression therapy, or during complete androgen blockade therapy and withdrawal. Documented by either criterion a (Radiological progression), OR criterion b (PSA progression).
- Radiological progression defined as any new/enlarging bone metastases or new/enlarging lymph node disease, consistent with prostate cancer.
OR
- PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility criteria).
Chemotherapy naïve and Vaccinia-experienced (previous smallpox vaccination). Currently using a GnRH agonist or antagonist (unless surgically castrated).
Exclusion Criteria:
Cancer-related pain requiring scheduled opioid narcotics for control (as needed, ≤ 2x per week is allowed).
Metastasis to organ systems other than lymph nodes and/or bone. Estimated PSA doubling time of <1 month as established within 6 months of the anticipated first dose of vaccine or placebo.
Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer. Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the first planned dose of PROSTVAC-V/F.
History of prior malignancies other than prostate cancer within the past 3 years, excluding successfully resected basal or squamous cell carcinoma of the skin.
Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months) Confirmed positive for HIV, hepatitis B, and /or hepatitis C. Immunodeficiency or splenectomy. History of or active autoimmune disease, persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled.
History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alaska Clinical Research Center, Llc | Anchorage | Alaska | United States | 99508 |
| 2 | Scottsdale Healthcare | Scottsdale | Arizona | United States | 85258 |
| 3 | Alta Bates Summit Medical Center | Berkeley | California | United States | 94704 |
| 4 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 5 | Prostate Oncology Specialists, Inc. | Marina Del Rey | California | United States | 90292 |
| 6 | Desert Hematology-Oncology | Rancho Mirage | California | United States | 92270 |
| 7 | San Bernardino Urological Associates | San Bernardino | California | United States | 92404 |
| 8 | San Diego Clinical Trials | San Diego | California | United States | 92120 |
| 9 | Sharp Memorial Hospital | San Diego | California | United States | 92123 |
| 10 | VA San Diego Healthcare System | San Diego | California | United States | 92161 |
| 11 | Stanford Advanced Medical Center | Stanford | California | United States | 94305 |
| 12 | University of Colorado | Aurora | Colorado | United States | 80045 |
| 13 | The Urology Center of Colorado | Denver | Colorado | United States | 80211 |
| 14 | Washington Cancer Institute | Washington | District of Columbia | United States | 20010 |
| 15 | South Florida Medical Research | Aventura | Florida | United States | 33180 |
| 16 | Manatee Medical Research Institute, LLC | Bradenton | Florida | United States | 34205 |
| 17 | Florida Urology Physicians | Fort Myers | Florida | United States | 33908 |
| 18 | Lakeland Regional Cancer Center | Lakeland | Florida | United States | 33805 |
| 19 | Pinellas Urology, Inc. | Saint Petersburg | Florida | United States | 33710 |
| 20 | James A Haley Veteran Affairs Medical Center | Tampa | Florida | United States | 33612 |
| 21 | Palm Beach Cancer Institute | West Palm Beach | Florida | United States | 33401 |
| 22 | North Idaho Urology | Coeur d'Alene | Idaho | United States | 83814 |
| 23 | Jesse Brown VA | Chicago | Illinois | United States | 60612 |
| 24 | First Urology PSC | Jeffersonville | Indiana | United States | 47130 |
| 25 | Northern Indiana Cancer Research Consortium | South Bend | Indiana | United States | 46601 |
| 26 | The Iowa Clinic, PC Iowa Urology | West Des Moines | Iowa | United States | 50266 |
| 27 | Tulane University | New Orleans | Louisiana | United States | 70112 |
| 28 | Ochsner Cancer Institute | New Orleans | Louisiana | United States | 70121 |
| 29 | Maryland Prostate Center | Baltimore | Maryland | United States | 21201 |
| 30 | Greater Baltimore Medical Center | Baltimore | Maryland | United States | 21204 |
| 31 | Union Memorial Hospital | Baltimore | Maryland | United States | 21218 |
| 32 | Walter Reed Army Medical Center | Bethesda | Maryland | United States | 20889 |
| 33 | National Cancer Institute - Center for Cancer Research | Bethesda | Maryland | United States | 20892 |
| 34 | Myron Murdock M.D. LLC | Greenbelt | Maryland | United States | 20770 |
| 35 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 36 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 37 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 38 | Kansas City VA Medical Center | Kansas City | Missouri | United States | 64128 |
| 39 | GU Research Network, LLC | Omaha | Nebraska | United States | 68130 |
| 40 | Nebraska Cancer Specialists | Omaha | Nebraska | United States | 68130 |
| 41 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89169 |
| 42 | VA Sierra Nevada HealthCare System | Reno | Nevada | United States | 89502 |
| 43 | Delaware Valley Urology LLC - Westhampton | Mount Laurel | New Jersey | United States | 08054 |
| 44 | The Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
| 45 | Brooklyn Urology Research Group | Brooklyn | New York | United States | 11215 |
| 46 | University Urology Associates | New York | New York | United States | 10016 |
| 47 | Hudson Valley Urology, P.C. | Poughkeepsie | New York | United States | 12601 |
| 48 | Presbyterian Hospital Center for Cancer Research | Charlotte | North Carolina | United States | 28204 |
| 49 | Northeast Urology Research | Concord | North Carolina | United States | 28025 |
| 50 | Regional Cancer Care PA | Durham | North Carolina | United States | 27704 |
| 51 | Durham VA Medical Center | Durham | North Carolina | United States | 27705 |
| 52 | W.G. (Bill) Hefner VA Medical Center | Salisbury | North Carolina | United States | 28144 |
| 53 | St. Alexius Medical Center | Bismarck | North Dakota | United States | 58501 |
| 54 | Gabrail Cancer Center | Canton | Ohio | United States | 44718 |
| 55 | University of Cincinnati Medical Center | Cincinnati | Ohio | United States | 45267 |
| 56 | University Hospitals Case Medical Center | Cleveland | Ohio | United States | 44106 |
| 57 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 58 | Columbus Urology Research | Columbus | Ohio | United States | 43221 |
| 59 | Willamette Valley Cancer Center | Springfield | Oregon | United States | 97477 |
| 60 | Urologic Consultants of Southeaster PA LLP | Bala-Cynwyd | Pennsylvania | United States | 19004 |
| 61 | Urological Associates Of Lancaster | Lancaster | Pennsylvania | United States | 17604 |
| 62 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 63 | UPMC Cancer Pavillion | Pittsburgh | Pennsylvania | United States | 15232 |
| 64 | Mount Nittany Medical Center | State College | Pennsylvania | United States | 16801 |
| 65 | Ralph H Johnson VAMC | Charleston | South Carolina | United States | 29401 |
| 66 | WJB Dorn VA Medical Center | Columbia | South Carolina | United States | 29209 |
| 67 | Greenville Hospital System | Greenville | South Carolina | United States | 29605 |
| 68 | Carolina Urologic Research Center | Myrtle Beach | South Carolina | United States | 29572 |
| 69 | University of TN Medical Center | Knoxville | Tennessee | United States | 37920 |
| 70 | The West Clinic, P.C. | Memphis | Tennessee | United States | 38120 |
| 71 | James H. Quillen Veterans Affairs Medical Center | Mountain Home | Tennessee | United States | 37684 |
| 72 | Urology Associates, PC | Nashville | Tennessee | United States | 37209 |
| 73 | Urology Clinics of North Texas | Dallas | Texas | United States | 75225 |
| 74 | Mary Crowley Cancer Research Center | Dallas | Texas | United States | 75230 |
| 75 | Central Texas Veterans Health Care System | Temple | Texas | United States | 76504 |
| 76 | Scott and White Memorial Hospital | Temple | Texas | United States | 76508 |
| 77 | Salt Lake Research | Salt Lake City | Utah | United States | 84107 |
| 78 | University of Utah | Salt Lake City | Utah | United States | 84132 |
| 79 | White River Junction Veterans Affairs Medical Center | White River Junction | Vermont | United States | 05009 |
| 80 | Virginia Oncology Associates PC | Norfolk | Virginia | United States | 23502 |
| 81 | Virginia Mason Medical Center | Seattle | Washington | United States | 98101 |
| 82 | Madigan Army Medical Center | Tacoma | Washington | United States | 98431 |
| 83 | The Schiffler Cancer Center | Wheeling | West Virginia | United States | 26003 |
| 84 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 85 | Sydney Haematology and Oncology Clinic | St Leonards | New South Wales | Australia | 2065 |
| 86 | Calvary Mater Newcastle | Waratah | New South Wales | Australia | 2298 |
| 87 | Redcliffe Hospital | Redcliffe | Queensland | Australia | 4020 |
| 88 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | 5000 |
| 89 | Austin Hospital | Heidelberg | Victoria | Australia | 3084 |
| 90 | Monash Medical Centre - Moorabbin Campus | Bentleigh East | Australia | 3165 | |
| 91 | Barwon Health | Geelong | Australia | 3220 | |
| 92 | St John of God Hospital | Subiaco | Australia | 6008 | |
| 93 | Border Medical Oncology | Wodonga | Australia | 3690 | |
| 94 | Princess Alexandra Hospital | Woolloongabba | Australia | 4102 | |
| 95 | Ziekenhuisnetwerk Antwerpen - AZ Middelheim | Antwerp | Belgium | 2020 | |
| 96 | Cliniques Universitaires Saint-Luc | Brussels | Belgium | 1200 | |
| 97 | Institut Jules Bordet | Bruxelles | Belgium | 1000 | |
| 98 | AZ Maria Middelares | Gent | Belgium | 9000 | |
| 99 | UZ Leuven | Leuven | Belgium | 3000 | |
| 100 | H.-Hartziekenhuis Roeselare-Menen vzw | Roeselare | Belgium | 8800 | |
| 101 | Southern Interior Medical Research Inc. | Kelowna | British Columbia | Canada | V1Y 2H4 |
| 102 | Capital District Health Authority | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 103 | Brantford Urology Research | Brantford | Ontario | Canada | N3S 6T6 |
| 104 | Cambridge Memorial Hospital | Cambridge | Ontario | Canada | N1R3G2 |
| 105 | St. Josephs Healthcare Hamilton Research Ethics Board | Hamilton | Ontario | Canada | L8N 4A6 |
| 106 | Queen's University at Kingston | Kingston | Ontario | Canada | K7L3J7 |
| 107 | London Health Sciences Centre | London | Ontario | Canada | N6A 5W9 |
| 108 | The Female/Male Health Centres | Oakville | Ontario | Canada | L6H 3P1 |
| 109 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
| 110 | Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | Canada | H2L 4M1 |
| 111 | Centre Hospitalier Universitaire de Quebec Hotel Dieu | Quebec | Canada | G1R 2J6 | |
| 112 | Aalborg Sygehus | Aalborg | Denmark | 9100 | |
| 113 | Rigshospitalet | Copenhagen | Denmark | 2200 | |
| 114 | Frederiksberg Hospital | Frederiksberg | Denmark | DK-2000 | |
| 115 | Herlev Hospital | Herlev | Denmark | 2730 | |
| 116 | Holstebro Sygehus | Holstebro | Denmark | 7500 | |
| 117 | Storstrømmens Sygehus Næstved | Næstved | Denmark | DK-4700 | |
| 118 | Skejby Sygehus | Århus N | Denmark | DK-8200 | |
| 119 | East Tallinn Central Hospital | Tallinn | Estonia | EE-10138 | |
| 120 | North Estonia Medical Centre Foundation | Tallinn | Estonia | EE-13419 | |
| 121 | Tartu University Hospital | Tartu | Estonia | EE-51014 | |
| 122 | Centre Paul Papin | Angers | France | 49933 | |
| 123 | Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries | La Roche Sur Yon | France | 85925 | |
| 124 | Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes | Lyon | France | 69373 | |
| 125 | Centre d'Oncologie de Gentilly | Nancy | France | 54000 | |
| 126 | HIA du Val de Grâce | Paris | France | 75005 | |
| 127 | Institut Curie | Paris | France | 75005 | |
| 128 | Fondation Hôpital Saint-Joseph | Paris | France | 75014 | |
| 129 | Institut Mutualiste Montsouris | Paris | France | 75014 | |
| 130 | Centre Hospitalier Lyon Sud | Pierre Benite | France | 69495 | |
| 131 | Institut Jean Godinot - Centre de lutte contre le cancer | Reims | France | 51056 | |
| 132 | Clinique Armoricaine de Radiologie | Saint Brieuc | France | 22000 | |
| 133 | Hôpital Bretonneau | Tours | France | 37044 | |
| 134 | Centre Alexis Vautrin - Centre Régional de lutte contre le cancer de Lorraine | Vandoeuvre les Nancy | France | 54511 | |
| 135 | Stadtisches Klinikum Muchen GmbH | Munich | Bavaria | Germany | 81737 |
| 136 | Universitätsklinikum Bonn | Bonn | Germany | 53127 | |
| 137 | Universitätsklinikum Essen | Essen | Germany | 45147 | |
| 138 | Klinikum der Johann-Wolfgang-Goethe-Universität Frankfurt am Main | Frankfurt | Germany | 60590 | |
| 139 | Chirurgische Universitätsklinik Freiburg | Freiburg | Germany | 79106 | |
| 140 | Martini-Klinik am UKE GmbH | Hamburg | Germany | 20246 | |
| 141 | Klinikum der Friedrich-Schiller-Universität Jena | Jena | Germany | 07743 | |
| 142 | Universitätsmedizin der JGU Mainz | Mainz | Germany | 55131 | |
| 143 | Klinikum der Philipps-Universität Marburg | Marburg | Germany | 35043 | |
| 144 | Studienpraxis Urologie | Reutlingen | Germany | 72766 | |
| 145 | Universitätsklinikum Tübingen | Tübingen | Germany | 72076 | |
| 146 | Universitatsklinikum Ulm | Ulm | Germany | 89075 | |
| 147 | Universitätsklinikum Ulm | Ulm | Germany | 89075 | |
| 148 | Universitätsklinikum Würzburg | Würzburg | Germany | 97080 | |
| 149 | Landspitali University Hospital | Reykjavik | Iceland | IS-101 | |
| 150 | Soroka University Medical Center | Beer Sheva | Israel | 84101 | |
| 151 | Bnei Zion Medical Center | Haifa | Israel | 31048 | |
| 152 | Rambam Medical Center | Haifa | Israel | 31096 | |
| 153 | Edith Wolfson Medical Center | Holon | Israel | 58100 | |
| 154 | Hadassah University Hospital Ein Kerem | Jerusalem | Israel | 91120 | |
| 155 | The Chaim Sheba Medical Center | Ramat-Gan | Israel | 52621 | |
| 156 | Assaf Harofe Medical Center | Tzrifin | Israel | 70300 | |
| 157 | NKI-AVL | Amsterdam | Netherlands | 1066 CX | |
| 158 | VUMC | Amsterdam | Netherlands | 1081 HV | |
| 159 | Academisch Ziekenhuis Maastricht | Maastricht | Netherlands | 6229 HX | |
| 160 | Radboudumc | Nijmegen | Netherlands | 6525 GA | |
| 161 | Erasmus MC | Rotterdam | Netherlands | 3015CE | |
| 162 | AMEDS CENTRUM Sp. z o.o. | Grodzisk Mazowiecki | Poland | 05-827 | |
| 163 | Urologica Praktyka Lekarska Adam Marcheluk | Siedlce | Poland | 08-110 | |
| 164 | Szpital sw Elzbiety - Mokotowskie Centrum Medyczne Sp. z o. o. | Warsaw | Poland | 02-616 | |
| 165 | Miedzyleski Szpital Specjalistyczny w Warszawie | Warsaw | Poland | 04-749 | |
| 166 | Klinika Urologii i Onkologii Urologicznej, Uniwersytecki Szpital Kliniczny we Wrocławiu | Wroclaw | Poland | 50-556 | |
| 167 | Ponce School of Medicine | Ponce | Puerto Rico | 00716 | |
| 168 | Alliance for Research and Knowledge | San Juan | Puerto Rico | 00910 | |
| 169 | Arkhangelsk Regional Clinical Oncology Dispensary | Arkhangelsk | Russian Federation | 163045 | |
| 170 | Chelyabinsk Regional Clinical Oncology Dispensary | Chelyabinsk | Russian Federation | 454087 | |
| 171 | Kazan State Medical University | Kazan | Russian Federation | 420111 | |
| 172 | Moscow Research Oncology Institute n.a. P.A.Gertsen | Moscow | Russian Federation | 125248 | |
| 173 | Clinical Oncology Dispensary | Omsk | Russian Federation | 644013 | |
| 174 | Orel Oncology Center | Orel | Russian Federation | 302020 | |
| 175 | Orenburg Regional Clinical Oncology Center | Orenburg | Russian Federation | 460021 | |
| 176 | St. Petersburg Medical Academy of Postgraduate Education | St. Petersburg | Russian Federation | 191015 | |
| 177 | St. Petersburg State Medical University n.a. I.P. Pavlov | St. Petersburg | Russian Federation | 197022 | |
| 178 | City Hospital #15 | St. Petersburg | Russian Federation | 198205 | |
| 179 | "Orkli" LLC | St. Petersburg | Russian Federation | 199178 | |
| 180 | "Clinic Andros" LLC | St.Petersburg | Russian Federation | 197136 | |
| 181 | Stavropol Regional Clinical Oncology Dispensary | Stavropol | Russian Federation | 355047 | |
| 182 | Regional Clinical Oncology Center | Vladimir | Russian Federation | 600020 | |
| 183 | Regional Clinical Oncology Hospital | Yaroslavl | Russian Federation | 150040 | |
| 184 | Hospital Clinico Universitario de Santiago de Compostela | Santiago de Compostela | Galicia | Spain | 15706 |
| 185 | Hospital 12 de Octubre | Madrid | Madrid, Communidad De | Spain | 28041 |
| 186 | Clinica Universitaria de Navarra | Pamplona | Navarra | Spain | 31008 |
| 187 | Hospital Nuestra Señora de Sonsoles | Avila | Spain | 05004 | |
| 188 | Hospital del Mar | Barcelona | Spain | 08003 | |
| 189 | Hospital Vall D´Hebron | Barcelona | Spain | 08035 | |
| 190 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | 08041 | |
| 191 | Hospital Universitario Reina Sofia | Córdoba | Spain | 14004 | |
| 192 | Hospital General Universitario de Elche | Elche | Spain | 03203 | |
| 193 | Hospital General Universitario Gregorio Marañon | Madrid | Spain | 28007 | |
| 194 | MD Anderson International Espana | Madrid | Spain | 28033 | |
| 195 | Centro Integral Oncológico Clara Campal | Madrid | Spain | 28050 | |
| 196 | Hospital Universitario Fundación Alcorcón | Madrid | Spain | 28922 | |
| 197 | Hospital Universitario Puerta de Hierro | Majadahonda | Spain | 28222 | |
| 198 | Althaia: Xarxa Assistencial de Manresa | Manresa | Spain | 08243 | |
| 199 | Hospital General Carlos Haya | Málaga | Spain | 29010 | |
| 200 | Hospital Son Espases | Palma de Mallorca | Spain | 07010 | |
| 201 | Fundación Hospital Manacor | Palma de Mallorca | Spain | 07198 | |
| 202 | Clinica Universitaria de Navarra | Pamplona | Spain | 31008 | |
| 203 | Corporació Sanitaria Parc Taulí | Sabadell | Spain | 08208 | |
| 204 | Hospital Virgen del Rocio | Sevilla | Spain | 41013 | |
| 205 | Hospital Mutua de Terrassa | Terrassa | Spain | 08221 | |
| 206 | Hospital Universitario Miguel Servet | Zaragoza | Spain | 50009 | |
| 207 | Bristol Haematology & Oncology Centre | Bristol | UK | United Kingdom | BS2 8ED |
| 208 | University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital | Birmingham | United Kingdom | B15 2TH | |
| 209 | Velindre Hospital | Cardiff | United Kingdom | CF14 2TL | |
| 210 | Beatson West of Scotland Cancer Centre | Glasgow | United Kingdom | G12 0YN | |
| 211 | University of Surrey | Guildford | United Kingdom | GU2 7XP | |
| 212 | Leeds Teaching Hospitals NHS Trust, St James's University Hospital | Leeds | United Kingdom | LS9 7TF | |
| 213 | St Bartholomews Hospital | London | United Kingdom | EC1M 6BQ | |
| 214 | The Royal Marsden | London | United Kingdom | SW3 6JJ | |
| 215 | St Mary's Hospital | London | United Kingdom | W2 1NY | |
| 216 | Christie Hospital | Manchester | United Kingdom | M20 4BX | |
| 217 | Plymouth Hospitals NHS Trust, Derriford Hospital | Plymouth | United Kingdom | PL6 8DH | |
| 218 | University of Southampton | Southampton | United Kingdom | SO16 6YD | |
| 219 | Royal Marsden Hospital | Sutton | United Kingdom | SM2 5PT | |
| 220 | The Clatterbridge Cancer Centre NHS Foundation Trust | Wirral | United Kingdom | CH63 4JY |
Sponsors and Collaborators
- Bavarian Nordic
Investigators
- Principal Investigator: James L. Gulley, MD, National Cancer Institute (NCI)
- Principal Investigator: Philip Kantoff, MD, Dana-Farber Cancer Institute
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Bavarian Nordic
ClinicalTrials.gov Identifier:
NCT01322490
Other Study ID Numbers:
- BNIT-PRV-301
First Posted:
Mar 24, 2011
Last Update Posted:
Sep 4, 2019
Last Verified:
Aug 1, 2019
Keywords provided by Bavarian Nordic
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Phase 3, randomized, placebo-controlled, multicenter, multi-country efficacy trial of PROSTVAC administered SC to adult males with asymptomatic mCRPC, and was designed to enroll approximately 1200 men. Subjects were randomly assigned with equal probability (1:1:1) to one of three double-blind treatment arms. |
|---|---|
| Pre-assignment Detail | Screening activities were completed within 28 days prior to the first dose of any medication and were completed prior to dosing. Subjects who required anti-androgen wash-out specifically for this protocol were consented prior to beginning withdrawal of therapy, however, no other screening procedures were performed the subject was deemed eligible. |
| Arm/Group Title | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control |
|---|---|---|---|
| Arm/Group Description | PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days). | PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days). | Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days). |
| Period Title: Treatment Period | |||
| STARTED | 432 | 432 | 433 |
| Treated | 429 | 429 | 428 |
| COMPLETED | 300 | 279 | 280 |
| NOT COMPLETED | 132 | 153 | 153 |
| Period Title: Treatment Period | |||
| STARTED | 409 | 408 | 413 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 409 | 408 | 413 |
Baseline Characteristics
| Arm/Group Title | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control | Total |
|---|---|---|---|---|
| Arm/Group Description | PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days). | PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days). | Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days). | Total of all reporting groups |
| Overall Participants | 432 | 432 | 433 | 1297 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
104
24.1%
|
121
28%
|
109
25.2%
|
334
25.8%
|
| >=65 years |
328
75.9%
|
311
72%
|
324
74.8%
|
963
74.2%
|
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
71.3
(8.00)
|
70.6
(8.42)
|
71.4
(8.33)
|
71.1
(8.25)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Male |
432
100%
|
432
100%
|
433
100%
|
1297
100%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
11
2.5%
|
11
2.5%
|
18
4.2%
|
40
3.1%
|
| Not Hispanic or Latino |
418
96.8%
|
421
97.5%
|
415
95.8%
|
1254
96.7%
|
| Unknown or Not Reported |
3
0.7%
|
0
0%
|
0
0%
|
3
0.2%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
1
0.2%
|
0
0%
|
0
0%
|
1
0.1%
|
| Asian |
7
1.6%
|
6
1.4%
|
7
1.6%
|
20
1.5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
0.2%
|
0
0%
|
1
0.1%
|
| Black or African American |
17
3.9%
|
25
5.8%
|
23
5.3%
|
65
5%
|
| White |
404
93.5%
|
400
92.6%
|
403
93.1%
|
1207
93.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
3
0.7%
|
0
0%
|
0
0%
|
3
0.2%
|
| Region of Enrollment (Count of Participants) | ||||
| Puerto Rico |
2
0.5%
|
1
0.2%
|
2
0.5%
|
5
0.4%
|
| United States |
124
28.7%
|
141
32.6%
|
129
29.8%
|
394
30.4%
|
| United Kingdom |
31
7.2%
|
29
6.7%
|
39
9%
|
99
7.6%
|
| Iceland |
4
0.9%
|
3
0.7%
|
3
0.7%
|
10
0.8%
|
| Russia |
50
11.6%
|
52
12%
|
61
14.1%
|
163
12.6%
|
| Spain |
45
10.4%
|
33
7.6%
|
48
11.1%
|
126
9.7%
|
| Canada |
30
6.9%
|
13
3%
|
26
6%
|
69
5.3%
|
| Netherlands |
6
1.4%
|
4
0.9%
|
6
1.4%
|
16
1.2%
|
| Belgium |
12
2.8%
|
8
1.9%
|
10
2.3%
|
30
2.3%
|
| Denmark |
34
7.9%
|
42
9.7%
|
32
7.4%
|
108
8.3%
|
| Poland |
6
1.4%
|
9
2.1%
|
5
1.2%
|
20
1.5%
|
| Israel |
13
3%
|
11
2.5%
|
5
1.2%
|
29
2.2%
|
| Australia |
36
8.3%
|
38
8.8%
|
27
6.2%
|
101
7.8%
|
| France |
29
6.7%
|
28
6.5%
|
28
6.5%
|
85
6.6%
|
| Germany |
3
0.7%
|
13
3%
|
6
1.4%
|
22
1.7%
|
| Estonia |
7
1.6%
|
7
1.6%
|
6
1.4%
|
20
1.5%
|
| Randomization Stratum (Count of Participants) | ||||
| PSA < 50 ng/mL and LDH < 200 U/L |
168
38.9%
|
168
38.9%
|
168
38.8%
|
504
38.9%
|
| PSA < 50 ng/mL and LDH >= 200 U/L |
135
31.3%
|
135
31.3%
|
135
31.2%
|
405
31.2%
|
| PSA >= 50 ng/mL and LDH < 200 U/L |
65
15%
|
64
14.8%
|
64
14.8%
|
193
14.9%
|
| PSA >= 50 ng/mL and LDH >= 200 U/L |
64
14.8%
|
65
15%
|
66
15.2%
|
195
15%
|
Outcome Measures
| Title | Overall Survival |
|---|---|
| Description | The time between the date of randomization and the date of death due to any cause. Subjects who did not experience death or the competing events of "definite" loss to follow-up or withdrawal of consent were right censored at the date of last contact. OS was calculated using the formula: OS = Date of death/competing event/censoring - date of randomization + 1. |
| Time Frame | Randomization through the date of death due to any cause. Subjects were followed up for approximately 6 years from the first subject randomized to the completion of the study. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat, including all randomized subjects. |
| Arm/Group Title | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control |
|---|---|---|---|
| Arm/Group Description | PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days). | PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days). | Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days). |
| Measure Participants | 432 | 432 | 433 |
| Median (95% Confidence Interval) [Months] |
34.4
|
33.2
|
34.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PROSTVAC-V/F-TRICOM + GM-CSF Placebo, Placebo Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | One-sided p-value is from a stratified log-rank test for PROSTVAC-V/F-TRICOM + GM-CSF placebo vs. Placebo Control with Treatment Arm included in model. Stratification is by randomization strata. | |
| Statistical Test of Hypothesis | p-Value | 0.4742 |
| Comments | The overall type-one error probability for the entire trial was designed as a one-sided P=0.025. There were two main overall comparisons, which necessitated a type-one error probability to 0.0125 for each comparison using a Bonferroni correction. | |
| Method | Log Rank | |
| Comments | The primary analysis method was a stratified log-rank test, and was performed using the ITT Set analyzing data according to the randomized arm. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PROSTVAC-V/F-TRICOM + GM-CSF, Placebo Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | One-sided p-value is from a stratified log-rank test for PROSTVAC-V/F-TRICOM + GM-CSF vs. Placebo Control with Treatment Arm included in model. Stratification is by randomization strata. | |
| Statistical Test of Hypothesis | p-Value | 0.5885 |
| Comments | The overall type-one error probability for the entire trial was designed as a one-sided P=0.025. There were two main overall comparisons, which necessitated a type-one error probability to 0.0125 for each comparison using a Bonferroni correction. | |
| Method | Log Rank | |
| Comments | The primary analysis method was a stratified log-rank test, and was performed using the ITT Set analyzing data according to the randomized arm. | |
| Title | Number of Subjects Alive Without Event at 6 Months |
|---|---|
| Description | A binary assessment that was performed for the 6-months timepoint for the categories of radiographic progression, pain progression, initiation of chemotherapy or death. Subjects without an event prior to 6-months were evaluated at 6-months. Subjects without event by 6-months and were not evaluated at 6-months were assumed to have had an event and analyzed as such. Progression events were defined as: (1) Two new lesions on bone scan, new metastases on CT scans, or an increased size of nodal lesions per RECIST 1.1. Bone or CT scans occurring prior to calendar month 6 were used to determine radiographic progression. (2) Introduction of scheduled opioid narcotics for cancer-related pain control. (3) Initiation of chemotherapy for prostate cancer was assessed as collected on progression forms as well as in cancer treatment and concomitant medications logs. (4) Death. |
| Time Frame | Randomization through Week 25/End of Treatment visit. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat, including all randomized subjects. |
| Arm/Group Title | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control |
|---|---|---|---|
| Arm/Group Description | PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days). | PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days). | Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days). |
| Measure Participants | 432 | 432 | 433 |
| Count of Participants [Participants] |
127
29.4%
|
121
28%
|
131
30.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PROSTVAC-V/F-TRICOM + GM-CSF Placebo, Placebo Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | Odds Ratio and Wald 95% CI estimates are for odds of alive without event for PROSTVAC-V/F-TRICOM + GM-CSF placebo vs. Placebo Control and are from a logistic regression model with Treatment Arm included in model stratified by randomization strata. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.9588 | |
| Confidence Interval |
(2-Sided) 95% 0.7144 to 1.2867 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The Alive Without Event endpoint was analyzed using stratified logistic regression. The 95% CI on the odds ratio estimate was computed as the measure of the magnitude of effect. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PROSTVAC-V/F-TRICOM + GM-CSF, Placebo Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | Odds Ratio and Wald 95% CI estimates are for odds of alive without event for PROSTVAC-V/F-TRICOM + GM-CSF vs. Placebo Control and are from a logistic regression model with Treatment Arm included in model stratified by randomization strata. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.8941 | |
| Confidence Interval |
(2-Sided) 95% 0.6647 to 1.2026 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The Alive Without Event endpoint was analyzed using stratified logistic regression. The 95% CI on the odds ratio estimate was computed as the measure of the magnitude of effect. | |
Adverse Events
| Time Frame | Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events. | |||||
| Arm/Group Title | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control | |||
| Arm/Group Description | PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days). | PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days). | Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days). | |||
All Cause Mortality |
||||||
| PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 252/432 (58.3%) | 254/432 (58.8%) | 248/433 (57.3%) | |||
Serious Adverse Events |
||||||
| PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 56/429 (13.1%) | 56/429 (13.1%) | 53/428 (12.4%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 1/429 (0.2%) | 1 | 1/429 (0.2%) | 1 | 1/428 (0.2%) | 1 |
| Disseminated intravascular coagulation | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 1/428 (0.2%) | 1 |
| Febrile neutropenia | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Haemolytic uraemic syndrome | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Histiocytosis haematophagic | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Normochromic normocytic anaemia | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Thrombocytopenia | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Cardiac disorders | ||||||
| Acute coronary syndrome | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 1/428 (0.2%) | 1 |
| Acute myocardial infarction | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Angina pectoris | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Arrhythmia supraventricular | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Atrial fibrillation | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 3/428 (0.7%) | 4 |
| Atrial flutter | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Cardiac failure | 2/429 (0.5%) | 2 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Mitral valve incompetence | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Myocardial infarction | 1/429 (0.2%) | 1 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Myocardial ischaemia | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Supraventricular tachycardia | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Ear and labyrinth disorders | ||||||
| Vertigo | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Eye disorders | ||||||
| Retinal detachment | 1/429 (0.2%) | 2 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal pain | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 1/428 (0.2%) | 1 |
| Abdominal pain upper | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Anal haemorrhage | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Constipation | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Diarrhoea | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Gastritis | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Ileus | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Ileus paralytic | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Inguinal hernia | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Inguinal hernia strangulated | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Intestinal obstruction | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Large intestinal obstruction | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Nausea | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 2/428 (0.5%) | 2 |
| Oesophageal varices haemorrhage | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Proctitis | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Vomiting | 2/429 (0.5%) | 2 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| General disorders | ||||||
| Death | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| General physical health deterioration | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Non-cardiac chest pain | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Pain | 0/429 (0%) | 0 | 2/429 (0.5%) | 2 | 0/428 (0%) | 0 |
| Pyrexia | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Hepatobiliary disorders | ||||||
| Cholelithiasis | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Infections and infestations | ||||||
| Appendiceal abscess | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Bacterial infection | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Bronchopneumonia | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Catheter site infection | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Cellulitis | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Gastroenteritis | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Gastroenteritis viral | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Lobar pneumonia | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Oral candidiasis | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Perinephric abscess | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Pneumonia | 1/429 (0.2%) | 1 | 2/429 (0.5%) | 2 | 1/428 (0.2%) | 1 |
| Pyelonephritis | 1/429 (0.2%) | 1 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Sepsis | 1/429 (0.2%) | 1 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Spinal cord infection | 0/429 (0%) | 0 | 2/429 (0.5%) | 2 | 0/428 (0%) | 0 |
| Staphylococcal sepsis | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Urinary tract infection | 1/429 (0.2%) | 1 | 3/429 (0.7%) | 3 | 1/428 (0.2%) | 1 |
| Urosepsis | 2/429 (0.5%) | 3 | 0/429 (0%) | 0 | 2/428 (0.5%) | 2 |
| Viral infection | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 1/428 (0.2%) | 1 |
| Injury, poisoning and procedural complications | ||||||
| Brain herniation | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Cervical vertebral fracture | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Cystitis radiation | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Fall | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Gun shot wound | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Hepatic haematoma | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Humerus fracture | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Post procedural haematuria | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Radiation oesophagitis | 1/429 (0.2%) | 1 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Spinal cord injury | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Sternal fracture | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Toxicity to various agents | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Upper limb fracture | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Vascular bypass dysfunction | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Investigations | ||||||
| Blood creatinine increased | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Troponin increased | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Cell death | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Dehydration | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 1/428 (0.2%) | 1 |
| Diabetes mellitus | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Gout | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Hyponatraemia | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Bone pain | 1/429 (0.2%) | 1 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Pathological fracture | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 2/428 (0.5%) | 2 |
| Rhabdomyolysis | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Spinal osteoarthritis | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Carcinoma in situ of skin | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Colon cancer | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Lung neoplasm malignant | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 1/428 (0.2%) | 1 |
| Metastases to central nervous system | 1/429 (0.2%) | 1 | 1/429 (0.2%) | 1 | 1/428 (0.2%) | 1 |
| Metastases to meninges | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Metastatic pain | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 2/428 (0.5%) | 2 |
| Neuroendocrine carcinoma of the skin | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Renal cell carcinoma | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Squamous cell carcinoma of skin | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Tumour pain | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Nervous system disorders | ||||||
| Carotid artery stenosis | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Cerebral haematoma | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Cerebral haemorrhage | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 1/428 (0.2%) | 1 |
| Cerebrovascular accident | 1/429 (0.2%) | 1 | 2/429 (0.5%) | 2 | 1/428 (0.2%) | 2 |
| Cervical cord compression | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Ischaemic stroke | 1/429 (0.2%) | 1 | 2/429 (0.5%) | 2 | 0/428 (0%) | 0 |
| Nerve compression | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Peripheral motor neuropathy | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Presyncope | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Radiculopathy | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Spinal cord compression | 1/429 (0.2%) | 1 | 4/429 (0.9%) | 4 | 2/428 (0.5%) | 2 |
| Syncope | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 2/428 (0.5%) | 2 |
| Transient ischaemic attack | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Psychiatric disorders | ||||||
| Confusional state | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Delirium | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Renal and urinary disorders | ||||||
| Acute kidney injury | 1/429 (0.2%) | 1 | 1/429 (0.2%) | 1 | 1/428 (0.2%) | 1 |
| Dysuria | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Haematuria | 2/429 (0.5%) | 4 | 7/429 (1.6%) | 8 | 4/428 (0.9%) | 4 |
| Hydronephrosis | 5/429 (1.2%) | 5 | 1/429 (0.2%) | 1 | 2/428 (0.5%) | 2 |
| Obstructive uropathy | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Pyelocaliectasis | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Renal failure | 2/429 (0.5%) | 3 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Ureteric obstruction | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Urethral stenosis | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 2/428 (0.5%) | 2 |
| Urinary bladder haemorrhage | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Urinary retention | 6/429 (1.4%) | 6 | 4/429 (0.9%) | 4 | 1/428 (0.2%) | 1 |
| Urinary tract obstruction | 1/429 (0.2%) | 1 | 2/429 (0.5%) | 2 | 0/428 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Acute respiratory failure | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Bronchiectasis | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Pleural effusion | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Pulmonary embolism | 5/429 (1.2%) | 5 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Pulmonary oedema | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Vascular disorders | ||||||
| Aortic aneurysm | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Aortic stenosis | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Intermittent claudication | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
| Lymphoedema | 0/429 (0%) | 0 | 1/429 (0.2%) | 1 | 0/428 (0%) | 0 |
| Vascular compression | 1/429 (0.2%) | 1 | 0/429 (0%) | 0 | 0/428 (0%) | 0 |
| Venous thrombosis limb | 0/429 (0%) | 0 | 0/429 (0%) | 0 | 1/428 (0.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||
| PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 351/429 (81.8%) | 367/429 (85.5%) | 346/428 (80.8%) | |||
| Gastrointestinal disorders | ||||||
| Constipation | 39/429 (9.1%) | 44 | 26/429 (6.1%) | 29 | 28/428 (6.5%) | 31 |
| Diarrhoea | 38/429 (8.9%) | 41 | 28/429 (6.5%) | 31 | 21/428 (4.9%) | 22 |
| Nausea | 51/429 (11.9%) | 65 | 51/429 (11.9%) | 62 | 36/428 (8.4%) | 41 |
| General disorders | ||||||
| Asthenia | 32/429 (7.5%) | 46 | 37/429 (8.6%) | 50 | 49/428 (11.4%) | 52 |
| Chills | 34/429 (7.9%) | 50 | 44/429 (10.3%) | 60 | 35/428 (8.2%) | 42 |
| Fatigue | 94/429 (21.9%) | 117 | 105/429 (24.5%) | 149 | 91/428 (21.3%) | 116 |
| Influenza like illness | 44/429 (10.3%) | 68 | 55/429 (12.8%) | 86 | 36/428 (8.4%) | 63 |
| Injection site erythema | 201/429 (46.9%) | 594 | 256/429 (59.7%) | 765 | 200/428 (46.7%) | 626 |
| Injection site induration | 46/429 (10.7%) | 98 | 67/429 (15.6%) | 140 | 58/428 (13.6%) | 128 |
| Injection site oedema | 22/429 (5.1%) | 41 | 23/429 (5.4%) | 47 | 19/428 (4.4%) | 45 |
| Injection site pain | 109/429 (25.4%) | 252 | 128/429 (29.8%) | 247 | 119/428 (27.8%) | 247 |
| Injection site pruritus | 77/429 (17.9%) | 145 | 109/429 (25.4%) | 235 | 57/428 (13.3%) | 124 |
| Injection site swelling | 73/429 (17%) | 187 | 101/429 (23.5%) | 247 | 67/428 (15.7%) | 183 |
| Injection site warmth | 15/429 (3.5%) | 31 | 28/429 (6.5%) | 55 | 21/428 (4.9%) | 38 |
| Oedema peripheral | 21/429 (4.9%) | 22 | 24/429 (5.6%) | 24 | 12/428 (2.8%) | 12 |
| Pyrexia | 37/429 (8.6%) | 50 | 91/429 (21.2%) | 142 | 53/428 (12.4%) | 63 |
| Infections and infestations | ||||||
| Urinary tract infection | 23/429 (5.4%) | 28 | 17/429 (4%) | 22 | 22/428 (5.1%) | 28 |
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 39/429 (9.1%) | 43 | 25/429 (5.8%) | 29 | 31/428 (7.2%) | 33 |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 49/429 (11.4%) | 70 | 50/429 (11.7%) | 69 | 55/428 (12.9%) | 71 |
| Back pain | 62/429 (14.5%) | 70 | 43/429 (10%) | 46 | 48/428 (11.2%) | 55 |
| Musculoskeletal pain | 15/429 (3.5%) | 15 | 28/429 (6.5%) | 33 | 21/428 (4.9%) | 27 |
| Myalgia | 36/429 (8.4%) | 46 | 35/429 (8.2%) | 47 | 43/428 (10%) | 61 |
| Pain in extremity | 28/429 (6.5%) | 34 | 28/429 (6.5%) | 28 | 23/428 (5.4%) | 26 |
| Nervous system disorders | ||||||
| Dizziness | 18/429 (4.2%) | 20 | 17/429 (4%) | 19 | 22/428 (5.1%) | 25 |
| Headache | 32/429 (7.5%) | 67 | 43/429 (10%) | 61 | 36/428 (8.4%) | 45 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 25/429 (5.8%) | 26 | 20/429 (4.7%) | 24 | 15/428 (3.5%) | 16 |
| Vascular disorders | ||||||
| Hot flush | 23/429 (5.4%) | 24 | 20/429 (4.7%) | 21 | 12/428 (2.8%) | 15 |
| Hypertension | 28/429 (6.5%) | 33 | 23/429 (5.4%) | 26 | 22/428 (5.1%) | 25 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Program Lead, Clinical Operations |
|---|---|
| Organization | Bavarian Nordic A/S |
| Phone | + 45 3326 ext 8383 |
| info@bavarian-nordic.com |
Responsible Party:
Bavarian Nordic
ClinicalTrials.gov Identifier:
NCT01322490
Other Study ID Numbers:
- BNIT-PRV-301
First Posted:
Mar 24, 2011
Last Update Posted:
Sep 4, 2019
Last Verified:
Aug 1, 2019