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

University of Wisconsin, Madison3 sites in 1 country99 target enrollmentMay 23, 2011

ConditionsProstate Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: University of Wisconsin, Madison
Enrollment: 99
Locations: 3
Primary Endpoint: 2-year Metastasis-Free Survival Rate
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 23, 2011

End Date

June 30, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

University of Wisconsin, Madison

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

2-year Metastasis-Free Survival Rate

Time Frame: 2 years

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.