Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response
Trial Parameters
Brief 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).
Eligibility Criteria
Inclusion Criteria: * Histologically/cytologically confirmed adenocarcinoma of the prostate * Metastatic disease by conventional imaging * PSA of ≥5.0 ng/ml (5.0 ug/L) prior to commencement of ADT * Receipt of ADT for mCSPC for at least 6 months and no greater than 12 months at time of enrollment. * Receipt of ARPI (e.g. abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for at least 4 months at time of enrollment * Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment. * Serum testosterone \<1.7 nmol/L or 50 ng/dL. * PSA ≥ 0.2 ng/ml (0.2 ug/L) within 14 days of enrollment. If there is any rise in PSA since starting ADT and achieving castrate-level testosterone, PSA must be repeated and must not fulfill ineligibility criteria 4.2.1. * Candidate for docetaxel chemotherapy * ECOG Performance Status (PS) 0 to 2. * Adequate organ and marrow function measured within 14 days pr