PCF - Department of Defense Prostate Cancer Clinical Trials Consortium (PCCTC) Trials
Metastatic Prostate Cancer With Prior Hormonal Therapy

A Randomized Phase II Clinical Trial of Two Dose-Levels of Itraconazole in Patients with Metastatic Castration-Resistant Prostate Cancer

This Phase II randomized trial will evaluate the safety, tolerability, and possible effect of Itraconazole on 58 patients with metastatic castration-resistant prostate cancer who have not previously received chemotherapy. The proportion of patients who do not have prostate specific antigen (PSA) progression after 24 weeks of therapy will be determined by standard prostate-specific antigen (PSA) tests.

Participating PCCTC Sites: Memorial Sloan-Kettering Cancer Center; University of Michigan; Wayne State University/Karmanos Cancer Institute

For more information, go to:
http://clinicaltrials.gov/ct2/show/NCT00887458?term=A+Randomized+Phase+II+Clinical+Trial+of+Two+Dose-Levels+of+Itraconazole&rank=1

Phase II Trial of Exogenous Testosterone Plus Dutasteride for the Treatment of Castrate Metastatic Prostate Cancer

This Phase II open-label trial will evaluate the safety, tolerability, and possible effect of daily treatment of 3.5 mg of dutasteride and 15g of testosterone treatment (AndroGel®) on 30 patients with metastatic castration-resistant prostate cancer. The anti-tumor effects of the treatment will be determined based on the proportion of patients remaining alive and progression free for 12 weeks from the start of testosterone treatment.

Participating PCCTC Sites: Memorial Sloan-Kettering Cancer Center; University of Washington

For more information, go to:
http://clinicaltrials.gov/ct2/show/NCT00853697?term=Phase+II+Trial+of+Exogenous+Testosterone+Plus+Dutasteride&rank=1

A Randomized, Phase II Trial of AZD2171 (Cediranib), Docetaxel, and Prednisone Compared to Docetaxel and Prednisone in Patients with Metastatic, Hormone Refractory Prostate Cancer (NCI 7451)

This Phase II trial being will evaluate the safety, tolerability, and possible effect of administering docetaxel and prednisone with or without 30 mg of AZD2171 to 104 metastatic castration-resistant prostate cancer patients. Potential activity of the treatment will be measured by standard prostate-specific antigen (PSA) tests and effect on well-established markers of progression free survival (PFS).

Participating PCCTC Sites: MD Anderson Cancer Center; University of Wisconsin; Wayne State University/Karmanos Cancer Center

For more information, go to:
http://clinicaltrials.gov/ct2/show/NCT00527124?term=A+Randomized%2C+Phase+II+Trial+of+AZD2171+%28Cediranib%29%2C+Docetaxel%2C+and+Prednisone&rank=1

A Phase II Trial of Genomic Guided Therapy with Dasatinib or Nilutamide in Metastatic CRPC

This Phase II trial will evaluate the safety, tolerability, and possible effect of dasatinib or nilutamide on patients with metastatic castration-resistant prostate cancer. Patients will undergo an image guided biopsy upon enrollment, the results of which will determine course of treatment (dasatinib or nilutamide).

Participating PCCTC Sites: Oregon Health and Science University; University of California, San Francisco; MD Anderson Cancer Center; University of Washington; Duke University; Wayne State University/Karmanos Cancer Center

For more information, go to:
http://clinicaltrials.gov/ct2/show/NCT00918385?term=A+Phase+II+Trial+of+Genomic+Guided+Therapy+with+Dasatinib+or+Nilutamide+in+Metastatic+CRPC&rank=1

A Phase Ib/II Study to Assess the Safety and Efficacy of AMG 102 in Combination with Mitoxantrone and Prednisone in Subjects with Previously Treated Castrate Resistant Prostate Cance

This Phase Ib/II trial will evaluate the safety, tolerability, and possible effect of AMG 102 in combination with Mitoxantrone and Prednisone on patients with castration-resistant prostate cancer who have received prior taxane-based chemotherapy.

Participating PCCTC Sites: Dana-Farber Harvard Cancer Center; Oregon Health and Science University; University of California, San Francisco; University of Washington; Wayne State University/Karmanos Cancer Center; University of Chicago

For more information, go to:
http://clinicaltrials.gov/ct2/show/NCT00770848?term=A+Phase+1b%2F2+Study+to+Assess+the+Safety+and+Efficacy+of+AMG+102+in+Combination+with+Mitoxantrone+and+Prednisone+in&rank=1

A Phase I, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Activity of HE3235 when Administered Orally to Patients with Prostate Cancer

This Phase I trial will evaluate the safety and tolerability of escalating daily dose levels of HE3235 (10 mg, 20 mg, 30 mg, 50 mg) when continuously administered orally to patients with metastatic castration-resistant prostate cancer who have failed at least one prior taxane regimen. The pharmacokinetic profiles of HE3235 at different dose levels will also be compared.

Participating PCCTC Sites: Memorial Sloan-Kettering Cancer Center; University of California, San Francisco; University of Washington

For more information, go to:
http://clinicaltrials.gov/ct2/show/NCT00716794?term=A+Phase+I%2C+Dose+Ranging+Study+of+the+Safety%2C+Tolerance%2C+Pharmacokinetics+and+Activity+of+HE3235+when+Administered+Orally+to+Patients+with+Prostate+Cancer&rank=1

A Phase I Study Evaluating a Second Generation Antisense Oligonucleotide (OGX-427) that Inhibits Heat Shock Protein 27 (Hsp27)

This Phase I open-label dose ranging study will evaluate the safety, tolerability, and pharmacokinetic profile of OGX-427 when administered as a single agent, up to a 1,000 mg dose level to 54 patients with metastatic castration-resistant prostate cancer (or breast, ovary, non-small cell lung cancer (NSCLC) or bladder cancer) who have failed previous treatment regimens. 

Participating PCCTC Sites: University of Washington; Wayne State University/Karmanos Cancer Center

For more information, go to:
http://www.clinicaltrials.gov/ct2/show/NCT00487786?term=A+Phase+I+Study+Evaluating+a+SEcond+Generation+Antisense&rank=1

A Randomized Phase II Study of Intermittent Chemotherapy or Intermittent Chemotherapy with Maintenance GM-CSF in Patients with Previously Untreated Metastatic Hormone Refractory Prostate Cancer

This Phase II randomized, two-arm study will evaluate safety, tolerability, and possible effects of 2 alternatives to standard treatment of HRPC with continuous docetaxel/prednisone. 90 patients with previously untreated metastatic hormone refractory prostate cancer will be administered intermittent docetaxel/prednisone or intermittent docetaxel/prednisone alternating with a relatively non-toxic, anti-prostate cancer therapy, granulocyte-macrophage colony-stimulating factor (GM-CSF).

Participating PCCTC Sites: Dana-Farber Harvard Cancer Center; Oregon Health and Science University; University of California, San Francisco; University of Washington

For more information, go to:
http://www.clinicaltrials.gov/ct2/show/NCT00488982?term=A+Randomized+Phase+II+Study+of+Intermittent+Chemotherapy+or+Intermittent+Chemotherapy+with+Maintenance+GM-CSF&rank=1

Phase II Study of Carboplatin plus Docetaxel in Patients with Anaplastic Prostate Carcinoma

This Phase II study will evaluate safety, tolerability, and possible effects of Carboplatin plus Docetaxel when administered to 120 patients with androgen independent stage IV prostate cancer with anaplastic features.  

Participating PCCTC Sites: University of California, San Francisco; MD Anderson Cancer Center

For more information, go to:
http://www.clinicaltrials.gov/ct2/show/NCT00514540?term=Phase+II+study+of+Carboplatin+plus+Docetaxel+in+Patients+with+Anaplastic+Prostate+Carcinoma&rank=1

For the full listing of trials, click here.