Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
Sponsor
Dendreon (Industry)
Overall Status
Completed
CT.gov ID
NCT00065442
Collaborator
(none)
512
71
2
66.1
7.2
0.1
Study Details
Study Description
Brief Summary
Provenge is an investigational product designed to activate a man's own antigen presenting cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an immune response against them.
Having completed Phase 1 and Phase 2 clinical trials, Provenge is now at the Phase 3 level. One important Phase 3 trial of Provenge has been completed; the current trial is also a Phase 3 study.
If you decide to participate and are eligible, you will be enrolled in the study and randomly assigned to receive either active product or placebo. There are two chances in three that you will receive Provenge. After receiving treatment, you will be monitored at regular intervals until the study endpoints are met. At the end of the trial, men who received placebo will have the opportunity to be treated with active product in another study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The trial is being conducted at multiple study centers throughout the United States. The trial is a double-blind, placebo-controlled trial. Participants must meet specific eligibility criteria. Study personnel will determine your eligibility in a telephone interview and through routine medical tests (physical exam, blood tests, imaging scans) done at a study center.
If you qualify for and decide to participate in the trial, you will have three product administrations over the course of one month.
Study Design
Study Type:
Interventional
Actual Enrollment
:
512 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double Blind, Placebo Controlled Phase 3 Trial of Immunotherapy With Autologous Antigen Presenting Cells Loading With PA2024 (Provenge(R), APC8015) in Men With Metastatic Androgen Independent Prostatic Adenocarcinoma
Study Start Date
:
Jul 1, 2003
Actual Primary Completion Date
:
Jan 1, 2009
Actual Study Completion Date
:
Jan 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: APC-Placebo
|
Biological: APC-Placebo
Each dose of APC-Placebo contains approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
|
| Active Comparator: Sipuleucel-T
|
Biological: Sipuleucel-T
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with a PAP-GM-CSF. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [Event-driven timeframe. Final analysis at 331 events.]
Time from randomization until death due to any cause.
Secondary Outcome Measures
- Time to Objective Disease Progression [Analysis conducted at the time of overall survival analysis]
Measured by imaging studies; confirmed by independent imaging review
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
To qualify for this trial, you must have ALL of the following:
-
Histologically documented adenocarcinoma of the prostate
-
Cancer that has progressed while on adequate hormone therapy. This state of the disease is androgen independent prostate cancer (AIPC).
-
Cancer that has spread outside the prostate (metastatic) to lymph nodes or bone. Please note that if your cancer has spread to organs (e.g., liver, lung, brain), you are not eligible for the study.
-
The absence of or minimal current cancer-related pain
Please note that there are additional eligibility criteria. The study center will determine if you meet all of the criteria.
Study personnel will explain the trial in detail and answer any questions you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, study personnel will explain the reasons.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | South Orange County Urological | Laguna Hills | California | United States | 92653 |
| 2 | LLUMC for Molecular Biology and Gene Therapy | Loma Linda | California | United States | 92354 |
| 3 | USC Keck School of Medicine | Los Angeles | California | United States | 90089-9178 |
| 4 | UCLA | Los Angeles | California | United States | 90095-1738 |
| 5 | Comprehensive Cancer Center | Palm Springs | California | United States | 982262 |
| 6 | Sutter Cancer Center | Sacramento | California | United States | 95816 |
| 7 | Kaiser Permanente Medical Group | San Diego | California | United States | 92120 |
| 8 | Sharp HealthCare | San Diego | California | United States | 92123 |
| 9 | UCSF Cancer Center | San Francisco | California | United States | 94115 |
| 10 | Rocky Mountain Cancer Center | Denver | Colorado | United States | 80220 |
| 11 | Connecticut Urological Research at Grove Hill | New Britain | Connecticut | United States | 06052 |
| 12 | Helen F. Graham Cancer Center | Newark | Delaware | United States | 19713 |
| 13 | Lombardi Cancer Center | Washington | District of Columbia | United States | 20057 |
| 14 | Walter Reid Army Medical Center | Washington | District of Columbia | United States | 20307 |
| 15 | Miami Cancer Center | Miami | Florida | United States | 33133 |
| 16 | Urology Center of South Florida | Miami | Florida | United States | 33173 |
| 17 | Cancer Centers of Florida | Ocoee | Florida | United States | 34761 |
| 18 | Hematology/Oncology Associates of the Treasure Coast | Port St. Lucie | Florida | United States | 34952 |
| 19 | Georgia Urology, P.A. | Atlanta | Georgia | United States | 30342 |
| 20 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 21 | Midwest Prostate & Urology Health Center | Chicago | Illinois | United States | 60640 |
| 22 | Loyola University | Maywood | Illinois | United States | 60153 |
| 23 | Lutheran General Cancer Center | Park Ridge | Illinois | United States | 60068 |
| 24 | Indiana University | Indianapolis | Indiana | United States | 46202 |
| 25 | Chesapeake Urology Associates | Baltimore | Maryland | United States | 21204 |
| 26 | Myron I Murdock MD LLC | Greenbelt | Maryland | United States | 20770 |
| 27 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115-6084 |
| 28 | Lahey Clinic (Department of Urology) | Burlington | Massachusetts | United States | 01805 |
| 29 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 30 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 31 | Nevada Cancer Institute | Las Vegas | Nevada | United States | 89135 |
| 32 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 33 | Associates in Urology, LLC | West Orange | New Jersey | United States | 07052 |
| 34 | Albany Regional Cancer Center | Albany | New York | United States | 12208 |
| 35 | The Urological Institute of Northeastern New York | Albany | New York | United States | 12208 |
| 36 | North Shore Hematology Oncology Associates | East Setauket | New York | United States | 11733 |
| 37 | New York Medical College | Hawthorne | New York | United States | 10532 |
| 38 | Beth Israel Cancer Center | New York | New York | United States | 10003 |
| 39 | New York University | New York | New York | United States | 10016 |
| 40 | Clinical Cancer Center | New York | New York | United States | 10029 |
| 41 | Mount Sinai School of Medicine | New York | New York | United States | 10029 |
| 42 | Staten Island Urological Research | Staten Island | New York | United States | 10304 |
| 43 | McKay Urology | Charlotte | North Carolina | United States | 28204 |
| 44 | Duke University Medical Center | Durham | North Carolina | United States | 27705 |
| 45 | University of Cincinnati | Cincinnati | Ohio | United States | 45267-0502 |
| 46 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 47 | EACRI | Portland | Oregon | United States | 97213 |
| 48 | Kaiser Permanente Medical Group | Portland | Oregon | United States | 97227-1191 |
| 49 | Oregon Urology Specialists | Springfield | Oregon | United States | 97477 |
| 50 | Center for Urologic Care | Bryn Mawr | Pennsylvania | United States | 19010 |
| 51 | Jefferson Medical College | Philadelphia | Pennsylvania | United States | 19107 |
| 52 | Grand Strand Urology | Myrtle Beach | South Carolina | United States | 29572 |
| 53 | Mary Crowley | Dallas | Texas | United States | 75246 |
| 54 | Urology Associates of North Texas | Fort Worth | Texas | United States | 76104 |
| 55 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 56 | University of Utah | Salt Lake City | Utah | United States | 84132 |
| 57 | Urology of Virginia, PC | Norfolk | Virginia | United States | 23502 |
| 58 | Urology of Virginia, PC | Norfolk | Virginia | United States | 23507 |
| 59 | Virginia Mason Medical Center | Seattle | Washington | United States | 98101 |
| 60 | Seattle Cancer Care Alliance | Seattle | Washington | United States | 98109 |
| 61 | Cancer Care Northwest | Spokane | Washington | United States | 99218 |
| 62 | Wenatchee Valley Medical Center | Wenatchee | Washington | United States | 98801 |
| 63 | University of Wisconsin, Madison | Madison | Wisconsin | United States | 53792 |
| 64 | University of Wisconsin | Madison | Wisconsin | United States | 53792 |
| 65 | St. Luke's Hospital Immunotherapy Program | Milwaukee | Wisconsin | United States | 53215 |
| 66 | Can-Med Medical Research, Inc. | Victoria | British Columbia | Canada | V8T 5G1 |
| 67 | London Health Sciences Centre | London | Ontario | Canada | N6A 4G5 |
| 68 | Urology CURC Scarborough | Scarborough | Ontario | Canada | M1S 4V5 |
| 69 | Sunnybrook & Women's College HSC | Toronto | Ontario | Canada | M4N 3M5 |
| 70 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
| 71 | Hospital Notre Dame du CHUM | Montreal | Quebec | Canada | H2L 4M1 |
Sponsors and Collaborators
- Dendreon
Investigators
- Study Chair: Paul Schellhammer, MD, Devine Tidewater Urology
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00065442
Other Study ID Numbers:
- D9902B
- NCT00084760
First Posted:
Jul 24, 2003
Last Update Posted:
Sep 6, 2010
Last Verified:
Sep 1, 2010
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were randomized between August 2003 and November 2007 across 75 clinical trial sites. |
|---|---|
| Pre-assignment Detail | Participants were screened for evaluation of subject eligibility and performance of baseline tests/procedures. |
| Arm/Group Title | APC-Placebo | Sipuleucel-T |
|---|---|---|
| Arm/Group Description | All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals. | All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart. |
| Period Title: Overall Study | ||
| STARTED | 171 | 341 |
| COMPLETED | 46 | 121 |
| NOT COMPLETED | 125 | 220 |
Baseline Characteristics
| Arm/Group Title | APC-Placebo | Sipuleucel-T | Total |
|---|---|---|---|
| Arm/Group Description | All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals. | All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart. | Total of all reporting groups |
| Overall Participants | 171 | 341 | 512 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
70.1
(9.0)
|
71.1
(8.9)
|
70.8
(8.9)
|
| Age, Customized (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
70
|
72
|
71
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
171
100%
|
341
100%
|
512
100%
|
Outcome Measures
| Title | Overall Survival |
|---|---|
| Description | Time from randomization until death due to any cause. |
| Time Frame | Event-driven timeframe. Final analysis at 331 events. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | APC-Placebo | Sipuleucel-T |
|---|---|---|
| Arm/Group Description | All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals. | All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart. |
| Measure Participants | 171 | 341 |
| Median (95% Confidence Interval) [Months] |
21.7
|
25.8
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | APC-Placebo, Sipuleucel-T |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.032 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | Cox regression model with treatment, PSA (ln), and LDH (ln) as the independent variables, stratified by randomization strata. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.775 | |
| Confidence Interval |
(2-Sided) 95% 0.614 to 0.979 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | sipuleucel-T/placebo | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | APC-Placebo, Sipuleucel-T |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.023 |
| Comments | ||
| Method | Log Rank | |
| Comments | Stratified by randomization strata. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.766 | |
| Confidence Interval |
(2-Sided) 95% 0.608 to 0.965 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Cox regression model with treatment as the independent variable, stratified by randomization strata (sipuleucel-T/placebo) | |
| Title | Time to Objective Disease Progression |
|---|---|
| Description | Measured by imaging studies; confirmed by independent imaging review |
| Time Frame | Analysis conducted at the time of overall survival analysis |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | APC-Placebo | Sipuleucel-T |
|---|---|---|
| Arm/Group Description | All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals. | All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart. |
| Measure Participants | 171 | 341 |
| Median (95% Confidence Interval) [Weeks] |
14.4
|
14.6
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | APC-Placebo, Sipuleucel-T |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.628 |
| Comments | ||
| Method | Log Rank | |
| Comments | Stratified by randomization strata | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.951 | |
| Confidence Interval |
(2-Sided) 95% 0.773 to 1.169 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Cox regression model with treatment as the independent variable, stratified by randomization strata | |
Adverse Events
| Time Frame | From randomization until time of overall survival analysis. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure. | |||
| Arm/Group Title | APC-Placebo | Sipuleucel-T | ||
| Arm/Group Description | All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals. | All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart. | ||
All Cause Mortality |
||||
| APC-Placebo | Sipuleucel-T | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| APC-Placebo | Sipuleucel-T | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 40/168 (23.8%) | 82/338 (24.3%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/168 (0.6%) | 1/338 (0.3%) | ||
| Disseminated intravascular coagulation | 1/168 (0.6%) | 1/338 (0.3%) | ||
| Thrombocytopenia | 0/168 (0%) | 1/338 (0.3%) | ||
| Cardiac disorders | ||||
| Acute myocardial infarction | 0/168 (0%) | 2/338 (0.6%) | ||
| Angina pectoris | 1/168 (0.6%) | 0/338 (0%) | ||
| Angina unstable | 1/168 (0.6%) | 0/338 (0%) | ||
| Arteriosclerosis coronary artery | 0/168 (0%) | 1/338 (0.3%) | ||
| Atrial fibrillation | 1/168 (0.6%) | 3/338 (0.9%) | ||
| Atrial flutter | 0/168 (0%) | 1/338 (0.3%) | ||
| Atrioventricular block second degree | 0/168 (0%) | 1/338 (0.3%) | ||
| Bundle branch block left | 0/168 (0%) | 1/338 (0.3%) | ||
| Cardiac arrest | 0/168 (0%) | 1/338 (0.3%) | ||
| Cardiac failure congestive | 2/168 (1.2%) | 2/338 (0.6%) | ||
| Cardiac tamponade | 1/168 (0.6%) | 0/338 (0%) | ||
| Coronary artery disease | 2/168 (1.2%) | 0/338 (0%) | ||
| Mitral valve incompetence | 0/168 (0%) | 1/338 (0.3%) | ||
| Myocardial infarction | 1/168 (0.6%) | 0/338 (0%) | ||
| Myocardial ischaemia | 0/168 (0%) | 1/338 (0.3%) | ||
| Sinus arrhythmia | 0/168 (0%) | 1/338 (0.3%) | ||
| Tachycardia | 0/168 (0%) | 1/338 (0.3%) | ||
| Eye disorders | ||||
| Diplopia | 0/168 (0%) | 1/338 (0.3%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/168 (0.6%) | 1/338 (0.3%) | ||
| Abdominal pain upper | 0/168 (0%) | 1/338 (0.3%) | ||
| Colonic obstruction | 1/168 (0.6%) | 0/338 (0%) | ||
| Diverticulum intestinal haemorrhagic | 0/168 (0%) | 1/338 (0.3%) | ||
| Gastrointestinal haemorrhage | 0/168 (0%) | 1/338 (0.3%) | ||
| Ileus | 0/168 (0%) | 1/338 (0.3%) | ||
| Intestinal obstruction | 0/168 (0%) | 2/338 (0.6%) | ||
| Large intestine perforation | 1/168 (0.6%) | 0/338 (0%) | ||
| Nausea | 2/168 (1.2%) | 3/338 (0.9%) | ||
| Rectal haemorrhage | 0/168 (0%) | 1/338 (0.3%) | ||
| RECTAL OBSTRUCTION | 1/168 (0.6%) | 0/338 (0%) | ||
| Vomiting | 1/168 (0.6%) | 1/338 (0.3%) | ||
| General disorders | ||||
| Asthenia | 1/168 (0.6%) | 2/338 (0.6%) | ||
| Catheter site haemorrhage | 0/168 (0%) | 1/338 (0.3%) | ||
| Chest discomfort | 0/168 (0%) | 1/338 (0.3%) | ||
| Chills | 0/168 (0%) | 1/338 (0.3%) | ||
| Gait disturbance | 0/168 (0%) | 1/338 (0.3%) | ||
| Infusion related reaction | 0/168 (0%) | 1/338 (0.3%) | ||
| Pyrexia | 1/168 (0.6%) | 6/338 (1.8%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis | 0/168 (0%) | 1/338 (0.3%) | ||
| Infections and infestations | ||||
| Bacteraemia | 0/168 (0%) | 1/338 (0.3%) | ||
| Catheter bacteraemia | 0/168 (0%) | 2/338 (0.6%) | ||
| Catheter sepsis | 0/168 (0%) | 2/338 (0.6%) | ||
| Cellulitis | 1/168 (0.6%) | 1/338 (0.3%) | ||
| Escherichia bacteraemia | 1/168 (0.6%) | 0/338 (0%) | ||
| Incision site infection | 0/168 (0%) | 1/338 (0.3%) | ||
| Pneumonia | 2/168 (1.2%) | 2/338 (0.6%) | ||
| Sepsis | 2/168 (1.2%) | 1/338 (0.3%) | ||
| Staphylococcal bacteraemia | 0/168 (0%) | 1/338 (0.3%) | ||
| Staphylococcal sepsis | 0/168 (0%) | 1/338 (0.3%) | ||
| Urinary tract infection | 1/168 (0.6%) | 0/338 (0%) | ||
| Urinary tract infection Pseudomonal | 1/168 (0.6%) | 0/338 (0%) | ||
| Urosepsis | 1/168 (0.6%) | 0/338 (0%) | ||
| Catheter related infection | 1/168 (0.6%) | 0/338 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Cervical vertebral fracture | 0/168 (0%) | 1/338 (0.3%) | ||
| Device malfunction | 0/168 (0%) | 1/338 (0.3%) | ||
| Device occlusion | 1/168 (0.6%) | 1/338 (0.3%) | ||
| Gastroenteritis radiation | 0/168 (0%) | 1/338 (0.3%) | ||
| Hip fracture | 1/168 (0.6%) | 0/338 (0%) | ||
| Multiple fractures | 0/168 (0%) | 1/338 (0.3%) | ||
| Procedural hypotension | 0/168 (0%) | 1/338 (0.3%) | ||
| Rib fracture | 0/168 (0%) | 1/338 (0.3%) | ||
| Spinal compression fracture | 1/168 (0.6%) | 0/338 (0%) | ||
| Subdural haematoma | 1/168 (0.6%) | 2/338 (0.6%) | ||
| Thoracic vertebral fracture | 0/168 (0%) | 1/338 (0.3%) | ||
| Traumatic brain injury | 0/168 (0%) | 1/338 (0.3%) | ||
| Traumatic intracranial haemorrhage | 0/168 (0%) | 1/338 (0.3%) | ||
| Investigations | ||||
| Brain scan abnormal | 1/168 (0.6%) | 0/338 (0%) | ||
| Weight decreased | 0/168 (0%) | 1/338 (0.3%) | ||
| Metabolism and nutrition disorders | ||||
| Anorexia | 1/168 (0.6%) | 1/338 (0.3%) | ||
| Dehydration | 1/168 (0.6%) | 3/338 (0.9%) | ||
| Failure to thrive | 2/168 (1.2%) | 0/338 (0%) | ||
| Hyperglycaemia | 0/168 (0%) | 1/338 (0.3%) | ||
| Hyponatraemia | 0/168 (0%) | 1/338 (0.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 0/168 (0%) | 2/338 (0.6%) | ||
| Back pain | 1/168 (0.6%) | 1/338 (0.3%) | ||
| Muscular weakness | 1/168 (0.6%) | 2/338 (0.6%) | ||
| Musculoskeletal pain | 0/168 (0%) | 1/338 (0.3%) | ||
| Myalgia | 0/168 (0%) | 1/338 (0.3%) | ||
| Myositis | 0/168 (0%) | 1/338 (0.3%) | ||
| Neck pain | 0/168 (0%) | 1/338 (0.3%) | ||
| Osteoarthritis | 0/168 (0%) | 1/338 (0.3%) | ||
| Pain in extremity | 0/168 (0%) | 1/338 (0.3%) | ||
| Pathological fracture | 0/168 (0%) | 1/338 (0.3%) | ||
| Rhabdomyolysis | 0/168 (0%) | 1/338 (0.3%) | ||
| Scleroderma | 1/168 (0.6%) | 0/338 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Bile duct cancer | 0/168 (0%) | 1/338 (0.3%) | ||
| Colon cancer | 0/168 (0%) | 1/338 (0.3%) | ||
| Lung cancer metastatic | 0/168 (0%) | 1/338 (0.3%) | ||
| Lymphoma | 0/168 (0%) | 1/338 (0.3%) | ||
| Malignant melanoma | 0/168 (0%) | 1/338 (0.3%) | ||
| Metastases to bone | 1/168 (0.6%) | 0/338 (0%) | ||
| Metastases to central nervous system | 2/168 (1.2%) | 1/338 (0.3%) | ||
| Prostate cancer | 0/168 (0%) | 1/338 (0.3%) | ||
| Prostate cancer metastatic | 4/168 (2.4%) | 4/338 (1.2%) | ||
| Tumour flare | 0/168 (0%) | 1/338 (0.3%) | ||
| Nervous system disorders | ||||
| Brain mass | 0/168 (0%) | 1/338 (0.3%) | ||
| Cerebral infarction | 0/168 (0%) | 1/338 (0.3%) | ||
| Cerebrovascular accident | 3/168 (1.8%) | 6/338 (1.8%) | ||
| Haemorrhage intracranial | 0/168 (0%) | 1/338 (0.3%) | ||
| Lacunar infarction | 0/168 (0%) | 1/338 (0.3%) | ||
| Myasthenia gravis | 0/168 (0%) | 1/338 (0.3%) | ||
| Sciatica | 0/168 (0%) | 1/338 (0.3%) | ||
| Spinal cord compression | 2/168 (1.2%) | 4/338 (1.2%) | ||
| Syncope | 1/168 (0.6%) | 1/338 (0.3%) | ||
| Transient ischaemic attack | 0/168 (0%) | 2/338 (0.6%) | ||
| Renal and urinary disorders | ||||
| Bladder obstruction | 2/168 (1.2%) | 0/338 (0%) | ||
| Haematuria | 2/168 (1.2%) | 2/338 (0.6%) | ||
| Hydronephrosis | 2/168 (1.2%) | 1/338 (0.3%) | ||
| Obstructive uropathy | 2/168 (1.2%) | 0/338 (0%) | ||
| Renal failure | 1/168 (0.6%) | 1/338 (0.3%) | ||
| Renal failure acute | 4/168 (2.4%) | 1/338 (0.3%) | ||
| Ureteric obstruction | 1/168 (0.6%) | 0/338 (0%) | ||
| Urinary incontinence | 0/168 (0%) | 1/338 (0.3%) | ||
| Urinary tract obstruction | 1/168 (0.6%) | 0/338 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Aspiration | 1/168 (0.6%) | 0/338 (0%) | ||
| Chronic obstructive pulmonary disease | 0/168 (0%) | 1/338 (0.3%) | ||
| Dyspnoea | 0/168 (0%) | 2/338 (0.6%) | ||
| Hypoxia | 0/168 (0%) | 1/338 (0.3%) | ||
| Pleural effusion | 1/168 (0.6%) | 1/338 (0.3%) | ||
| Pleurisy | 0/168 (0%) | 1/338 (0.3%) | ||
| Pulmonary embolism | 0/168 (0%) | 4/338 (1.2%) | ||
| Pulmonary haemorrhage | 1/168 (0.6%) | 0/338 (0%) | ||
| Pulmonary oedema | 0/168 (0%) | 1/338 (0.3%) | ||
| Reexpansion pulmonary oedema | 0/168 (0%) | 1/338 (0.3%) | ||
| Respiratory failure | 3/168 (1.8%) | 0/338 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Hyperhidrosis | 0/168 (0%) | 1/338 (0.3%) | ||
| Toxic epidermal necrolysis | 0/168 (0%) | 1/338 (0.3%) | ||
| Vascular disorders | ||||
| Arteriosclerosis | 0/168 (0%) | 1/338 (0.3%) | ||
| Deep vein thrombosis | 3/168 (1.8%) | 1/338 (0.3%) | ||
| Haemorrhage | 1/168 (0.6%) | 0/338 (0%) | ||
| Hypertensive emergency | 0/168 (0%) | 1/338 (0.3%) | ||
| Hypotension | 0/168 (0%) | 1/338 (0.3%) | ||
| Pallor | 0/168 (0%) | 1/338 (0.3%) | ||
| Pelvic venous thrombosis | 0/168 (0%) | 1/338 (0.3%) | ||
| Venous thrombosis limb | 0/168 (0%) | 1/338 (0.3%) | ||
Other (Not Including Serious) Adverse Events |
||||
| APC-Placebo | Sipuleucel-T | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 162/168 (96.4%) | 334/338 (98.8%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 21/168 (12.5%) | 50/338 (14.8%) | ||
| Gastrointestinal disorders | ||||
| Constipation | 24/168 (14.3%) | 45/338 (13.3%) | ||
| Diarrhoea | 17/168 (10.1%) | 36/338 (10.7%) | ||
| Nausea | 35/168 (20.8%) | 95/338 (28.1%) | ||
| Vomiting | 20/168 (11.9%) | 60/338 (17.8%) | ||
| General disorders | ||||
| Asthenia | 13/168 (7.7%) | 37/338 (10.9%) | ||
| Chills | 21/168 (12.5%) | 183/338 (54.1%) | ||
| Fatigue | 64/168 (38.1%) | 132/338 (39.1%) | ||
| Influenza like illness | 6/168 (3.6%) | 33/338 (9.8%) | ||
| Oedema peripheral | 16/168 (9.5%) | 32/338 (9.5%) | ||
| Pain | 12/168 (7.1%) | 44/338 (13%) | ||
| Pyrexia | 23/168 (13.7%) | 99/338 (29.3%) | ||
| Infections and infestations | ||||
| Upper respiratory tract infection | 9/168 (5.4%) | 15/338 (4.4%) | ||
| Urinary tract infection | 12/168 (7.1%) | 22/338 (6.5%) | ||
| Injury, poisoning and procedural complications | ||||
| Citrate toxicity | 34/168 (20.2%) | 68/338 (20.1%) | ||
| Contusion | 9/168 (5.4%) | 9/338 (2.7%) | ||
| Investigations | ||||
| Weight decreased | 18/168 (10.7%) | 20/338 (5.9%) | ||
| Metabolism and nutrition disorders | ||||
| Anorexia | 27/168 (16.1%) | 24/338 (7.1%) | ||
| Decreased appetite | 11/168 (6.5%) | 21/338 (6.2%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 40/168 (23.8%) | 70/338 (20.7%) | ||
| Back pain | 61/168 (36.3%) | 116/338 (34.3%) | ||
| Bone pain | 18/168 (10.7%) | 32/338 (9.5%) | ||
| Flank pain | 10/168 (6%) | 9/338 (2.7%) | ||
| Muscles spasms | 9/168 (5.4%) | 24/338 (7.1%) | ||
| Musculoskeletal chest pain | 19/168 (11.3%) | 33/338 (9.8%) | ||
| Musculoskeletal pain | 20/168 (11.9%) | 44/338 (13%) | ||
| Myalgia | 8/168 (4.8%) | 33/338 (9.8%) | ||
| Neck pain | 7/168 (4.2%) | 20/338 (5.9%) | ||
| Pain in extremity | 25/168 (14.9%) | 49/338 (14.5%) | ||
| Nervous system disorders | ||||
| Dizziness | 16/168 (9.5%) | 49/338 (14.5%) | ||
| Headache | 8/168 (4.8%) | 54/338 (16%) | ||
| Hypoaesthesia | 5/168 (3%) | 18/338 (5.3%) | ||
| Paraesthesia | 26/168 (15.5%) | 45/338 (13.3%) | ||
| Paraesthesia oral | 21/168 (12.5%) | 41/338 (12.1%) | ||
| Psychiatric disorders | ||||
| Anxiety | 14/168 (8.3%) | 13/338 (3.8%) | ||
| Depression | 11/168 (6.5%) | 8/338 (2.4%) | ||
| Insomnia | 12/168 (7.1%) | 24/338 (7.1%) | ||
| Renal and urinary disorders | ||||
| Haematuria | 9/168 (5.4%) | 31/338 (9.2%) | ||
| Hydronephrosis | 12/168 (7.1%) | 13/338 (3.8%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 8/168 (4.8%) | 28/338 (8.3%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Hyperhidrosis | 1/168 (0.6%) | 18/338 (5.3%) | ||
| Rash | 9/168 (5.4%) | 16/338 (4.7%) | ||
| Vascular disorders | ||||
| Hypertension | 5/168 (3%) | 25/338 (7.4%) | ||
| Hypotension | 9/168 (5.4%) | 18/338 (5.3%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
A provision provides for sponsor review up to 45 days with the right to request modification based on disclosure of confidential information; extendable by 60 days to file a patent application.
Results Point of Contact
| Name/Title | Kathleen Picha |
|---|---|
| Organization | Dendreon Corporation |
| Phone | 206-274-6762 |
| kpicha@dendreon.com |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00065442
Other Study ID Numbers:
- D9902B
- NCT00084760
First Posted:
Jul 24, 2003
Last Update Posted:
Sep 6, 2010
Last Verified:
Sep 1, 2010