NCT03385655

Prostate Cancer Biomarker Enrichment and Treatment Selection

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Adavosertib	250mg, may dose escalate to 300mg if no drug-related GI tox in cycle 1
DRUG	Savolitinib	600mg once daily, orally.
DRUG	Darolutamide	600mg twice daily, orally.
DRUG	CFI-400945	Dose level assigned at enrollment, starting at 32mg/day on Days 1-7 and 15-21 or 15-28 depending on toxicity experienced.
DRUG	Ipatasertib	400mg daily 3 weeks on, 1 week off
DRUG	Durvalumab and Tremelimumab	Durvalumab 1500mg day 1 every 4 weeks; Tremelimumab 225mg day 1 cycle 1
DRUG	Carboplatin	AUC 5 IV 60min Day 1 q 21 days

Timeline

• Start date: 2018-08-01
• Primary completion: 2024-10-07
• Completion: 2025-12-31
• First posted: 2017-12-28
• Last updated: 2025-08-21

Locations

11 sites across 1 country: Canada