Vaccine Plus Booster Shots in Men With Prostate Cancer Undergoing Treatment With Radical Prostatectomy

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT02153918
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arm: 1
• Actual Duration (Months): 43.6
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

Background:

• Some men with prostate cancer have their prostate glands removed. The cancer can still come back. Researchers want to know if receiving a vaccine before prostate removal surgery can lead to less recurrence.

Objective:

• To see if a vaccine and booster shots given to men with prostate cancer before surgery changes the immune cells in the prostate gland.

Eligibility:

• Men age 18 and older who have prostate cancer that has not spread, and who want to have their prostate glands removed as treatment.

Design:

• Participants will be screened by their regular cancer care. They may have a small piece of prostate removed.

• Participants must practice effective birth control before and during the study treatment and for 1 month after the last vaccine booster.

• Participants will have a medical history, physical exam, and blood and liver tests. They will be asked about how they perform daily activities.

• Participants will have a magnetic resonance imaging (MRI) scan of the prostate. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the scanner.

• Participants will be injected with the vaccine, most likely in the leg. They will be injected with the vaccine booster 3 times over several weeks.

• At each booster visit, participants will have a medical history, physical exam, and blood and liver tests.

• Participants will have another MRI. Then they will have surgery to remove their prostate.

• Participants will have 2 follow-up visits during the year after surgery. They will have a medical history, physical exam, and blood test.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Prostatic Neoplasms; Neoplasms, Prostate	Biological: PROSTVAC-V/TRICOM; Biological: PROSTVAC-F/TRICOM	Phase 2

Detailed Description

Background

• Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death.

• Vaccine strategies represent a novel therapeutic approach in the treatment for prostate cancer. One potential target for a prostate cancer vaccine is prostatic specific antigen (PSA), due to its restricted expression on prostate cancer and normal prostatic epithelial cells.

• A neoadjuvant approach may be of potential benefit providing prolonged protection via the patient s immune system against future recurrence.

• PROSTVAC is a vaccine that induces strong immune responses, has shown promising evidence of activity in a randomized phase II study (8.5 month improvement in median overall survival) and is currently in phase III clinical testing.

• This vaccine has been tested in locally recurrent prostate cancer with substantial inflammatory infiltrates within the prostate seen following subcutaneous and intraprostatic injection.

Objectives

-The primary objective is to evaluate the post vaccine immunologic cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) cell infiltrate response of a neoadjuvant vaccine strategy in prostatectomy specimens in patients who plan to undergo radical prostatectomy.

Eligibility

• Patients must have biopsy proven prostate cancer and are surgical candidates for radical prostatectomy

• Must be of sufficient good health to be surgical candidates for radical prostatectomy and have elected radical prostatectomy for management of their prostate cancer

• Granulocyte count is greater than or equal to 1,500/mm(3), Platelet is greater than or equal to 50,000/mm(3), hemoglobin (Hgb) is greater than or equal to 8 g/dL, Bilirubin < 1.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5x upper limit of normal (ULN), Creatinine is less than or equal to 1.5 X ULN

• Pre-intervention biopsy tissue must be available either from outside institution or repeat biopsy

Design

• This study will utilize rV-PSA(L155)-TRICOM (PROSTVAC-V) as a priming vaccination followed by monthly boosting with rF-PSA (L155)-TRICOM (PROSTVAC-F) for 3 months.

• Patients will undergo radical prostatectomy after 4 months of treatment with PROSTVAC-V/F.

• The maximum accrual to the trial will be 27 patients.

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Neoadjuvant rFowlpox-PSA (L155)-TRICOM (Prostvac-F/TRICOM) in Combination With rVaccinia-PSA (L155)-TRICOM (Prostvac-V/TRICOM) in Men With Prostate Cancer Undergoing Treatment With Radical Prostatectomy
• Actual Study Start Date: May 31, 2014
• Actual Primary Completion Date: Jul 28, 2017
• Actual Study Completion Date: Jan 16, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vaccine Plus Booster Shots PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC	Biological: PROSTVAC-V/TRICOM; A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules.; Biological: PROSTVAC-F/TRICOM; A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.

Outcome Measures

Primary Outcome Measures

1. Changes From Baseline to After Surgery of Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Infiltrates [Baseline (pre vaccination) and approximately week 10]

   Immunologic CD4 and CD8 cell infiltrate response of a neoadjuvant prime/boost vaccine strategy in prostatectomy specimens. Prostate biopsy specimens are collected and stained for CD4 and CD8 cells. Quantification is reported as the number of stained cells per micron squared of surface area. Change will be noted by utilizing computer automated staining analysis. Density of cell infiltrate will be calculated and the pre and post vaccine values will be compared to determine response to vaccine.

Secondary Outcome Measures

1. Count of Participants With Change in Peripheral Prostatic Specific Antigen (PSA)-Specific T Cell Responses [Baseline (pre vaccination) and week 10]

   Change in peripheral prostatic specific antigen (PSA)-specific T cells will be assessed by the enzyme-linked immunospot (ELISPOT) assay. A change of >250 cluster of differentiation 4 (CD4) or cluster of differentiation 8 (CD8) cells producing cytokine or positive for cluster of differentiation 107a (CD107a) in response to PSA post vaccination relative to baseline will be considered evidence of an immunologic response to the vaccine. The number of subjects developing positive PSA-Specific T cell responses with vaccination will be reported.

2. Intraprostatic Treg Cell Infiltration With Cluster of Differentiation 4 (CD4)+Forkhead Box P3 (FOX-P3) Staining [Baseline (pre vaccination) and post surgery after last dose of vaccine, approximately week 10]

   Prostate biopsy samples collected at baseline and at surgery after last dose of vaccine will be stained for analysis of immune cell infiltrate. Quantification will be reported as number of stained cells per micron squared of surface area.

3. Prostatic Specific Antigen (PSA) Changes Secondary to Vaccination [Baseline (pre vaccination) and approximately week 10]

   A change in PSA secondary to vaccination is defined as an increase or decrease in PSA value beyond the baseline level. PSA levels of 4.0 ng/ml and lower are considered normal.

4. Magnetic Resonance Imaging (MRI) Changes Secondary to Vaccination [Baseline (pre vaccination) and approximately week 10]

   MRI of the prostate was performed for changes in imaging characteristics of prostate cancer pre and post vaccination. MRI changes secondary to vaccination is defined as increase or decrease in the size of lesions from baseline (pre-vaccine) measurements.

5. Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) [Date treatment consent signed to date off study, approximately 33 months and 5 days]

   Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

-INCLUSION CRITERIA

1. Patients must have histopathological documentation of adenocarcinoma of the prostate prior to starting this study and evaluable biopsy tissue (e.g., unstained slides or blocks) available for analysis. If evaluable tissue is not available, the patient must agree to undergo a pre-vaccination prostate biopsy on study as an alternative to having available tissue available.

2. Patients must be a surgical candidate for radical prostatectomy based on standard workup of prostatic specific antigen (PSA), biopsy results, and if necessary supplemental imaging.

3. Patients must have chosen radical prostatectomy as their definitive treatment of choice for management of their prostate cancer.

4. Patients must have a performance status of 0 to 1 according to the Eastern Cooperative Oncology Group (ECOG) criteria

5. No systemic steroid or steroid eye drop use within 2 weeks prior to initiation of experimental therapy. Limited doses of systemic steroids to prevent intravenous (IV) contrast, allergic reaction or anaphylaxis (in patients who have known contrast allergies) are allowed.

6. Hematological eligibility parameters (within one month of starting therapy):

• Granulocyte count greater than or equal to 1,500/mm(3)

• Platelet count greater than or equal to 50,000/mm(3)

• Hemoglobin (Hgb) greater than or equal to 8 g/dL

1. Biochemical eligibility parameters (within one month of starting therapy):

2. Hepatic function: Bilirubin < 1.5 mg/dl (OR in patients with Gilbert's syndrome, a total bilirubin less than or equal to 3.0 mg/dL), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal.-. Creatinine less than or equal to 1.5 X ULN

3. Creatinine less than or equal to 1.5 X ULN

4. Patients must be test negative for human immunodeficiency virus (HIV), Hepatitis B and C.

5. Patients must not have other active invasive malignancies within the past 2 years (with the exception of non-melanoma skin cancers) or life threatening illnesses.

6. Patients must be willing to travel to the study site for follow-up visits.

7. Patients must be greater or equal to18 years of age.

8. All patients who have received prior vaccination with vaccinia virus (for smallpox immunization) must not have a history of allergy to the vaccine.

9. Patients must understand and sign informed consent that explains the neoplastic nature of their disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, potential risks and toxicities, and the voluntary nature of participation.

10. The effects of the study agents used in this protocol on the developing human fetus are unknown. For this reason men must agree to use adequate contraception (abstinence,vasectomy, or female partner use of intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation) prior to study entry and for up to one month after the last vaccination.

EXCLUSION CRITERIA

1. Prior splenectomy.

2. The recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least 3 weeks after vaccination, their close household contacts (Close household contacts are those who share housing or have close physical contact):

• Persons with active or a history of eczema or other eczematoid skin disorders

• Those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves

• Pregnant or nursing women; children under 3 years of age

• Patients should have no evidence, as listed below, of being immunocompromised:

• HIV positivity due to the potential for decreased tolerance and risk for severe side effects.

• Hepatitis B or C positivity.

• Concurrent use of topical steroids (including steroid eye drops) or systemic steroids. This is to avoid immunosuppression which may lead to potential complications with vaccinia (priming vaccination). Nasal or inhaled steroid use is permitted.

1. Patients with known allergy to eggs.

2. Other serious intercurrent illness.

3. Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Association class II-IV congestive heart failure.

4. Patients with significant autoimmune disease that is active or potentially life threatening if activated.

5. Patients with clinically significant cardiomyopathy requiring treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland	United States	20892

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Peter A Pinto, M.D., National Cancer Institute (NCI)

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - May 5, 2017

More Information

Additional Information:

• NIH Clinical Center Detailed Web Page

Publications

• DiPaola RS, Plante M, Kaufman H, Petrylak DP, Israeli R, Lattime E, Manson K, Schuetz T. A phase I trial of pox PSA vaccines (PROSTVAC-VF) with B7-1, ICAM-1, and LFA-3 co-stimulatory molecules (TRICOM) in patients with prostate cancer. J Transl Med. 2006 Jan 3;4:1.
• Gulley JL, Heery CR, Madan RA, Walter BA, Merino MJ, Dahut WL, Tsang KY, Schlom J, Pinto PA. Phase I study of intraprostatic vaccine administration in men with locally recurrent or progressive prostate cancer. Cancer Immunol Immunother. 2013 Sep;62(9):1521-31. doi: 10.1007/s00262-013-1448-0. Epub 2013 Jul 9.
• Kantoff PW, Schuetz TJ, Blumenstein BA, Glode LM, Bilhartz DL, Wyand M, Manson K, Panicali DL, Laus R, Schlom J, Dahut WL, Arlen PM, Gulley JL, Godfrey WR. Overall survival analysis of a phase II randomized controlled trial of a Poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer. J Clin Oncol. 2010 Mar 1;28(7):1099-105. doi: 10.1200/JCO.2009.25.0597. Epub 2010 Jan 25.

• Responsible Party: Peter Pinto, M.D., Principal Investigator, National Institutes of Health Clinical Center (CC)
• ClinicalTrials.gov Identifier: NCT02153918
• Other Study ID Numbers: 140112; 14-C-0112
• First Posted: Jun 3, 2014
• Last Update Posted: Oct 12, 2018
• Last Verified: Sep 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peter Pinto, M.D., Principal Investigator, National Institutes of Health Clinical Center (CC): Surgery; Neoadjuvant; CD8 Cell Infiltrate Response; CD4 Cell Infiltrate Response; Vaccine
• Additional relevant MeSH terms: Prostatic Neoplasms; Neoplasms; Metronidazole

Study Results

Participant Flow

Arm/Group Title	Vaccine Plus Booster Shots
Arm/Group Description	PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Period Title: Overall Study
STARTED	27
COMPLETED	26
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Vaccine Plus Booster Shots
Arm/Group Description	PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Overall Participants	27
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	14 51.9%
>=65 years	13 48.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.24 (6.62)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	27 100%
Race/Ethnicity, Customized (Count of Participants)
Black or African American	3 11.1%
White	23 85.2%
Mexican, Puerto Rican, Central or So. Amer. or Oth	2 7.4%
Not meeting definition for Hispanic or Latino	25 92.6%
Multi-racial	1 3.7%
Region of Enrollment (participants) [Number]
United States	27 100%
Baseline Prostatic Specific Antigen (PSA) (ng/ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng/ml]	9.66 (10.45)
Magnetic Resonance Imaging (MRI) Prostate Volume at Baseline (cc) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cc]	45.70 (17.24)
Number of Lesions on MRI at Baseline (lesions) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [lesions]	2.04 (1.21)
Largest Lesion Size at Baseline (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	1.55 (0.92)
Number of Participants with Gleason Score 6-10 at Baseline (Count of Participants)
Gleason score 6-7 (3+4)	11 40.7%
Gleason score 7 (4+3)	8 29.6%
Gleason score 8-10	8 29.6%

Outcome Measures

1. Primary Outcome

Title	Changes From Baseline to After Surgery of Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Infiltrates
Description	Immunologic CD4 and CD8 cell infiltrate response of a neoadjuvant prime/boost vaccine strategy in prostatectomy specimens. Prostate biopsy specimens are collected and stained for CD4 and CD8 cells. Quantification is reported as the number of stained cells per micron squared of surface area. Change will be noted by utilizing computer automated staining analysis. Density of cell infiltrate will be calculated and the pre and post vaccine values will be compared to determine response to vaccine.
Time Frame	Baseline (pre vaccination) and approximately week 10

Outcome Measure Data

Analysis Population Description

Only 26 participants had available tissue for analysis.

Arm/Group Title	Vaccine Plus Booster Shots
Arm/Group Description	PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Measure Participants	26
Median CD4 at baseline	132.2
Median CD4 at week 10	153.7
Median CD8 at baseline	105.1
Median CD8 at week 10	140.5

2. Secondary Outcome

Title	Count of Participants With Change in Peripheral Prostatic Specific Antigen (PSA)-Specific T Cell Responses
Description	Change in peripheral prostatic specific antigen (PSA)-specific T cells will be assessed by the enzyme-linked immunospot (ELISPOT) assay. A change of >250 cluster of differentiation 4 (CD4) or cluster of differentiation 8 (CD8) cells producing cytokine or positive for cluster of differentiation 107a (CD107a) in response to PSA post vaccination relative to baseline will be considered evidence of an immunologic response to the vaccine. The number of subjects developing positive PSA-Specific T cell responses with vaccination will be reported.
Time Frame	Baseline (pre vaccination) and week 10

Outcome Measure Data

Analysis Population Description

25/27 pts analyzed because 2x10(6) viable cells are required to setup the stimulation assay for each antigen at each time point and one patient had no viable cells after thawing blood. One patient could not be analyzed due to an experimental error which was a clog in the flow cytometry that occurred during acquisition for the final assay readout.

Arm/Group Title	Vaccine Plus Booster Shots
Arm/Group Description	PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Measure Participants	25
CD4 CD107a	4 14.8%
CD4 interferon gamma (IFNq)	2 7.4%
CD4 interleukin-2 (IL2)	1 3.7%
CD4 tumor necrosis factor (TNF)	0 0%
CD8 CD107a	0 0%
CD8 IFNq	0 0%
CD8 IL2	0 0%
CD8 TNF	1 3.7%

3. Secondary Outcome

Title	Intraprostatic Treg Cell Infiltration With Cluster of Differentiation 4 (CD4)+Forkhead Box P3 (FOX-P3) Staining
Description	Prostate biopsy samples collected at baseline and at surgery after last dose of vaccine will be stained for analysis of immune cell infiltrate. Quantification will be reported as number of stained cells per micron squared of surface area.
Time Frame	Baseline (pre vaccination) and post surgery after last dose of vaccine, approximately week 10

Outcome Measure Data

Analysis Population Description

Only 26 subjects had available tissue for analysis.

Arm/Group Title	Vaccine Plus Booster Shots
Arm/Group Description	PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Measure Participants	26
CD4 at baseline	199.8 (195.3)
CD4 at surgery after last dose of vaccine	237.6 (289.9)
FOX-P3 at baseline	16.93 (29.3)
FOX-P3 at surgery after last dose of vaccine	5.466 (4.524)

4. Secondary Outcome

Title	Prostatic Specific Antigen (PSA) Changes Secondary to Vaccination
Description	A change in PSA secondary to vaccination is defined as an increase or decrease in PSA value beyond the baseline level. PSA levels of 4.0 ng/ml and lower are considered normal.
Time Frame	Baseline (pre vaccination) and approximately week 10

Outcome Measure Data

Analysis Population Description

One subject came off-study prior to radical prostatectomy.

Arm/Group Title	Vaccine Plus Booster Shots
Arm/Group Description	PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Measure Participants	26
PSA at Baseline	8.94 (9.96)
PSA at 10 Weeks	10.18 (15.45)

5. Secondary Outcome

Title	Magnetic Resonance Imaging (MRI) Changes Secondary to Vaccination
Description	MRI of the prostate was performed for changes in imaging characteristics of prostate cancer pre and post vaccination. MRI changes secondary to vaccination is defined as increase or decrease in the size of lesions from baseline (pre-vaccine) measurements.
Time Frame	Baseline (pre vaccination) and approximately week 10

Outcome Measure Data

Analysis Population Description

3 subjects did not have week 10 MRI performed.

Arm/Group Title	Vaccine Plus Booster Shots
Arm/Group Description	PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Measure Participants	24
Largest lesion measurement at baseline	1.58 (0.91)
Largest lesion measurement at 10 weeks	1.57 (0.94)

6. Secondary Outcome

Title	Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Description	Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame	Date treatment consent signed to date off study, approximately 33 months and 5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vaccine Plus Booster Shots
Arm/Group Description	PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Measure Participants	27
Count of Participants [Participants]	27 100%

Adverse Events

Time Frame	Date treatment consent signed to date off study, approximately 33 months and 5 days.
Arm/Group Title	Vaccine Plus Booster Shots
Arm/Group Description	PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
All Cause Mortality
	Vaccine Plus Booster Shots
	Affected / at Risk (%)	# Events
Total	0/27 (0%)
Serious Adverse Events
	Vaccine Plus Booster Shots
	Affected / at Risk (%)	# Events
Total	1/27 (3.7%)
Vascular disorders
Thromboembolic event	1/27 (3.7%)	1
Other (Not Including Serious) Adverse Events
	Vaccine Plus Booster Shots
	Affected / at Risk (%)	# Events
Total	27/27 (100%)
Blood and lymphatic system disorders
Anemia	9/27 (33.3%)	11
Cardiac disorders
Sinus bradycardia	3/27 (11.1%)	4
Sinus tachycardia	1/27 (3.7%)	1
Endocrine disorders
Hyperparathyroidism	1/27 (3.7%)	1
Eye disorders
Blurred vision	2/27 (7.4%)	2
Eye disorders - Other, Blepharitis	1/27 (3.7%)	1
Eye disorders - Other, Subconjunctival hemorrhage	2/27 (7.4%)	2
Eye pain	1/27 (3.7%)	1
Gastrointestinal disorders
Abdominal pain	1/27 (3.7%)	1
Bloating	1/27 (3.7%)	1
Diarrhea	2/27 (7.4%)	2
Gastroesophageal reflux disease	1/27 (3.7%)	1
Gastrointestinal disorders - Other, H. Pylori	1/27 (3.7%)	1
Hemorrhoids	1/27 (3.7%)	1
Nausea	2/27 (7.4%)	2
Rectal hemorrhage	1/27 (3.7%)	1
Vomiting	1/27 (3.7%)	2
General disorders
Chills	1/27 (3.7%)	1
Edema limbs	1/27 (3.7%)	1
Fatigue	14/27 (51.9%)	20
Fever	8/27 (29.6%)	9
Flu like symptoms	17/27 (63%)	29
Injection site reaction	27/27 (100%)	83
Pain	5/27 (18.5%)	7
Pain in extremity	4/27 (14.8%)	4
Immune system disorders
Allergic reaction	1/27 (3.7%)	1
Infections and infestations
Skin infection	1/27 (3.7%)	1
Injury, poisoning and procedural complications
Bruising	1/27 (3.7%)	1
Fall	1/27 (3.7%)	1
Wound complication	1/27 (3.7%)	1
Investigations
Alanine aminotransferase increased	1/27 (3.7%)	1
Aspartate aminotransferase increased	1/27 (3.7%)	1
Blood bilirubin increased	1/27 (3.7%)	1
Cholesterol high	3/27 (11.1%)	3
Creatinine increased	1/27 (3.7%)	1
Hemoglobin increased	1/27 (3.7%)	1
Lymphocyte count decreased	2/27 (7.4%)	4
Platelet count decreased	3/27 (11.1%)	3
White blood cell decreased	2/27 (7.4%)	2
Metabolism and nutrition disorders
Anorexia	1/27 (3.7%)	1
Hypercalcemia	1/27 (3.7%)	1
Hypertriglyceridemia	3/27 (11.1%)	3
Hypocalcemia	1/27 (3.7%)	1
Hypophosphatemia	4/27 (14.8%)	4
Musculoskeletal and connective tissue disorders
Arthralgia	3/27 (11.1%)	4
Back pain	3/27 (11.1%)	3
Musculoskeletal and connective tissue disorder - Other, specify	1/27 (3.7%)	1
Musculoskeletal and connective tissue disorder - Other, muscle spasms	2/27 (7.4%)	2
Myalgia	2/27 (7.4%)	2
Non-cardiac chest pain	1/27 (3.7%)	1
Nervous system disorders
Dizziness	2/27 (7.4%)	3
Dysgeusia	1/27 (3.7%)	2
Headache	3/27 (11.1%)	3
Paresthesia	5/27 (18.5%)	5
Peripheral motor neuropathy	1/27 (3.7%)	1
Peripheral sensory neuropathy	1/27 (3.7%)	1
Sinus pain	1/27 (3.7%)	3
Vasovagal reaction	1/27 (3.7%)	1
Psychiatric disorders
Anxiety	1/27 (3.7%)	1
Insomnia	1/27 (3.7%)	1
Renal and urinary disorders
Bladder spasm	1/27 (3.7%)	1
Hematuria	1/27 (3.7%)	1
Renal and urinary disorders - Other, weak urine stream	1/27 (3.7%)	2
Urinary incontinence	1/27 (3.7%)	1
Urinary urgency	1/27 (3.7%)	1
Reproductive system and breast disorders
Pelvic pain	1/27 (3.7%)	1
Testicular pain	1/27 (3.7%)	1
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis	2/27 (7.4%)	2
Cough	1/27 (3.7%)	1
Dyspnea	1/27 (3.7%)	1
Nasal congestion	1/27 (3.7%)	1
Respiratory, thoracic and mediastinal disorders - Other, specify	1/27 (3.7%)	1
Respiratory, thoracic and mediastinal disorders - Other, specify	1/27 (3.7%)	1
Skin and subcutaneous tissue disorders
Bullous dermatitis	1/27 (3.7%)	1
Pruritus	2/27 (7.4%)	2
Skin and subcutaneous tissue disorders - Other, redness	1/27 (3.7%)	1
Skin and subcutaneous tissue disorders - Other, erythema of right foot	1/27 (3.7%)	1
Skin and subcutaneous tissue disorders - Other, rash	1/27 (3.7%)	1
Skin and subcutaneous tissue disorders - Other, Specify	1/27 (3.7%)	1
Vascular disorders
Hypertension	8/27 (29.6%)	15
Thromboembolic event	1/27 (3.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.