Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer
Randomized Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) Versus GM-CSF Adjuvant in Patients With Non-Metastatic Prostate Cancer
6 other identifiers
interventional
99
1 country
3
Brief Summary
The investigators are trying to find new methods to treat prostate cancer. The approach the investigators are taking is to try to enhance patients' own immune response against the cancer. In this study the investigators will be testing the effectiveness of a vaccine that may be able to help the body fight prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started May 2011
Longer than P75 for phase_2 prostate-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2011
CompletedFirst Posted
Study publicly available on registry
April 26, 2011
CompletedStudy Start
First participant enrolled
May 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedResults Posted
Study results publicly available
November 25, 2020
CompletedJanuary 20, 2021
January 1, 2021
9.1 years
March 24, 2011
October 30, 2020
January 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
2-year Metastasis-Free Survival Rate
2-year Metastasis-Free Survival (MFS) Rate with the development of metastases by conventional imaging used to define progression (as defined by RECIST 1.1 criteria). The 2-year MFS rate estimates which were obtained using the Kaplan-Meier analysis (taking into account censoring) using the intention-to-treat population.
2 years
Secondary Outcomes (4)
Prostate Specific Antigen (PSA) Doubling Time (DT)
up to 9 months
Number and Severity of Observed Toxicities
2 years
Median Time to Radiographic Disease Progression
up to 2 years
PSA Progression Free Survival
up to 2 years
Study Arms (2)
pTVG-HP vaccine with GM-CSF
EXPERIMENTALpTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
GM-CSF alone
ACTIVE COMPARATORrhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
Interventions
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
Eligibility Criteria
You may qualify if:
- Histologic diagnosis of adenocarcinoma of the prostate
- Completion of local therapy by surgery and/or ablative radiation therapy at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and/or local lymph node involvement
- Rising prostate specific antigen (PSA) levels without scan evidence of metastatic disease
- Asymptomatic or mildly symptomatic and life expectancy of at least 4 months
You may not qualify if:
- Small cell or other variant prostate cancer histology
- Evidence of immunosuppression
- Prior treatment with androgen deprivation except if given neoadjuvantly or adjuvantly with radiation therapy or at time of prostatectomy. In this situation, no more than 24 months of androgen deprivation must have been given and treatment must not have been within 12 months prior to screening for this study.
- Serum testosterone at screening \< 50 ng/dL
- Known bone metastases or lymph node involvement as determined by bone scan or computed tomography (CT) scan of the abdomen and pelvis within 4 weeks of study entry
- Prior vaccine therapy for prostate cancer
- Known allergic reactions to granulocyte-macrophage colony-stimulating factor (GM-CSF)
- Severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the Medical Monitor, excess risk associated with study participation or study agent administration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Related Publications (1)
McNeel DG, Eickhoff JC, Johnson LE, Roth AR, Perk TG, Fong L, Antonarakis ES, Wargowski E, Jeraj R, Liu G. Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP [MVI-816]) in Patients With Progressive, Nonmetastatic, Castration-Sensitive Prostate Cancer. J Clin Oncol. 2019 Dec 20;37(36):3507-3517. doi: 10.1200/JCO.19.01701. Epub 2019 Oct 23.
PMID: 31644357RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Douglas McNeel
- Organization
- University of Wisconsin Carbone Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas McNeel, M.D., PhD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2011
First Posted
April 26, 2011
Study Start
May 23, 2011
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
January 20, 2021
Results First Posted
November 25, 2020
Record last verified: 2021-01