PCCTC Trials: Localized Prostate Cancer - Prostate Cancer Foundation

An Open Label, Phase 2 Trial of Immunotherapy with Sipuleucel-T (Provenge®) as Neoadjuvant Treatment in Men with Localized Prostate Cancer

This Phase II open-label study will evaluate the safety and induced immune response of Sipuleucel-T (Provenge®) when administered as 3 infusions given 6-7 weeks prior to radical prostatectomy in 40 localized prostate cancer patients. The immune response after treatment with Sipuleucel-T will be assessed by comparing tissue from the prostatectomy specimen with tissue from a biopsy sample obtained prior to treatment with the compound. Previous studies suggest that immunization with Sipuleucel-T may confer an advantage in overall survival in metastatic androgen independent prostate cancer patients.

Participating PCCTC Sites: Oregon Health and Science University; University of California, San Francisco; University of Washington

For more information, go to:
http://clinicaltrials.gov/ct2/show/NCT00715104?term=Sipuleucel-T+%28Provenge%C2%AE%29&rank=5

Maximal Suppression of the Androgen Axis In Clinically Localized Prostate Cancer

This Phase II randomized trial will evaluate the safety, tolerance, and potential effect of 3 months of combination anti-androgenic treatment on 36 localized prostate cancer patients prior to radical prostatectomy. Potential activity of the 3 different combined anti-androgenic treatment regimens will be measured by comparing tissue from preoperative and intraoperative biopsies. It is hypothesized that effective suppression of the androgen axis will lower prostatic hormone levels and minimize activation of the androgen receptor, thus aiding in tumor cell death.

Participating PCCTC Sites: Dana-Farber Harvard Cancer Center; University of Washington

A Randomized, Placebo-Controlled Pre-Surgical Study of the Effects of Pomegranate Pills in Men with Prostate Cancer Prior to Radical Prostatectomy

This Phase II blinded-label, randomized trial will evaluate the safety, tolerance, and potential effect of (1) Two Pom Wonderful® POM-X pills given daily to 70 localized prostate cancer patients for 4 weeks prior to radical prostatectomy. Potential activity of the compound will be measured by analyzing serum, urine, and tissue specimens to determine POMX bioavailability, and the compounds effects on prostate inflammation and tumor cell death.

Participating PCCTC Sites: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Duke University

Sunitinib, Hormonal Ablation and External Beam Radiation Therapy for High-Risk and Locally Advanced Prostate Cancer

This Phase I trial will evaluate the safety and tolerability of three different dose-levels of the angiogenesis inhibitor, sunitinib malate, in combination with hormone ablation and external beam radiation administered daily to 18 patients with high-risk localized prostate cancer. Angiogenesis inhibitors may improve the therapeutic index of radiation therapy thus translating into improved local control without significant added toxicity.

Participating PCCTC Sites: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; MD Anderson Cancer Center; Wayne State University/Karmanos Cancer Institute

This Phase II blinded-label, randomized trial will evaluate the safety and potential effect of Simvastatin administered daily to 44 patients with localized prostate cancer for 4 weeks prior to radical prostatectomy. It is hypothesized that statin therapy prior to prostatectomy will successfully target the mevalonate pathway in the human prostate and this intervention will favorably alter tumor biomarker status.

Participating PCCTC Sites: Oregon Health and Science University; Duke University

Investigator-Initiated Pilot Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy

This Phase II open-label, pilot study will evaluate the safety, tolerability, and potential effect of 50 mg of sunitinib malate administered daily for 4 weeks to patients with localized prostate cancer prior to scheduled prostatectomy.

PCF - Department of Defense Prostate Cancer Clinical Trials Consortium (PCCTC) Trials: Localized Prostate Cancer