NCT06592924

Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 830 (estimated)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs? This study would like to find out if this approach is better or worse than the usual approach for prostate cancer. The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).

Detailed description

This is an international multi-centre, open-label, randomized phase III trial comparing Docetaxel chemotherapy added to standard of care Androgen Deprivation Therapy (ADT) + Androgen-Receptor Pathway Inhibitor (ARPI) versus standard of care Androgen Deprivation Therapy (ADT) + Androgen-Receptor Pathway Inhibitor (ARPI) in participants with metastatic castration sensitive prostate cancer (mCSPC) who have a suboptimal PSA response after 6-12 months of androgen-targeting therapy.

Conditions

• Prostate Cancer (Adenocarcinoma)

Interventions

Type	Name	Description
DRUG	Abiraterone	Assigned prior to enrollment
DRUG	Enzalutamide	Assigned prior to enrollment
DRUG	Apalutamide	Assigned prior to enrollment
DRUG	Darolutamide (BAY 1841788)	Assigned prior to enrollment
DRUG	Docetaxel	Assigned at enrollment
DRUG	ADT	Physician's choice. Assigned prior to enrollment

Timeline

• Start date: 2025-05-28
• Primary completion: 2031-03-14
• Completion: 2031-04-15
• First posted: 2024-09-19
• Last updated: 2026-04-14

Locations

340 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study