Prostate Cancer Biomarker Enrichment and Treatment Selection

Official Title

Prostate Cancer Biomarker Enrichment and Treatment Selection (PC-BETS) Study

Summary:

The purpose of the pre-study screening is to test for DNA abnormalities or biomarkers.

Trial Description

Primary Outcome:

• Clinical benefit rate defined as proportion of patients who had PSA decline ≥ 50%, complete or partial objective response, or Stable disease for ≥ 12 weeks.

Secondary Outcome:

• Measure effect of each study drug on PSA decline
• Measure objective response as determined by RECIST 1.1 criteria
• Number and severity of adverse events
• Measure effect of each study drug on time to PSA progression
• To summarize progression-free survival
• To summarize overall survival

This testing will be done on a samples of blood to see whether or not patients are eligible to take part in one of the sub-studies. Each study will be looking at what effects a new drug or drugs has on prostate cancer and will also be looking at the side effects of treatment. The purpose of the main studies is to see if the biomarkers that were identified screening samples can help predict which patients are most likely to be helped by that drug or drugs and to see how the cancer cells respond to treatment.

View this trial on ClinicalTrials.gov