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Recruiting Phase 3 NCT06439225

Platinum and Taxane Chemo in Met Castration Resistant Prostate Cancer Patients With Alterations in DNA Damage Response Genes

Trial Parameters

Condition Metastatic Castration-resistant Prostate Cancer
Sponsor Canadian Cancer Trials Group
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 236
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2024-12-30
Completion 2029-09-30
Interventions
DocetaxelCarboplatin

Brief Summary

The usual approach for most patients who are not in a study is treatment with docetaxel. 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 approach? This study is being done to find out if this approach is better or worse than the usual approach for prostate cancer. The usual approach is defined as the care most people get for prostate cancer.

Eligibility Criteria

Inclusion Criteria: * Histologic diagnosis of adenocarcinoma of the prostate. The presence of neuroendocrine or small cell carcinoma will be exclusionary * Prior treatment with any ARPI, such as abiraterone, enzalutamide, apalutamide, or darotlutamide, is required. * Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior systemic or radiation therapy, with the exception of chemotherapy induced alopecia and grade 2 peripheral neuropathy, and have adequate washout as follows: * Longest of one of the following: * Two weeks or 5 half lives (whichever is longer) for oral therapies (such as abiraterone, apalutamide, enzalutamide, darolutamide and olaparib) * Standard cycle of standard IV or IM therapies (such as radium 223 or Lu-177-PSMA-617 * 2 weeks, 5 half lives, or standard cycle length (whichever is longer) for investigational agents * Previous major surgery is permitted provided that surgery occurred at least 28 days prior to participant enrollment

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