UCSF Helen Diller Family Comprehensive Cancer Center
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Protocol No.115510Principal InvestigatorFong, Lawrence
PhaseII (Cancer Control)
Age GroupAdultScopeNational
Secondary Protocol No.CO 08801
TitleRandomized Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) versus GM-CSF Adjuvant in Patients with Non-Metastatic Prostate Cancer
ObjectiveTo evaluate the 2-year metastasis-free survival of patients with non-metastatic prostate cancer (clinical stage D0) treated with a DNA vaccine encoding PAP, with GM-CSF as an adjuvant, versus patients treated with GM-CSF only.
Key Eligibility* 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
Applicable Disease SitesProstate
Participating InstitutionsMt. Zion
Eligibility Document115510_CTGovEligibility_NCT01341652.doc