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

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 prior to enrollment.
• •Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate.
• •Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
• •In accordance with CCTG policy, protocol treatment is to begin within 5 working days of participant enrollment.
• •If the participant and the participant's partner are of childbearing potential, they must agree to use medically accepted methods of contraception
• •HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• •Participant access to all protocol therapies must be confirmed prior to enrollment
• •High-grade neuroendocrine prostate cancer or small cell features.