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).
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.
Inclusion Criteria: Histologically/cytologically confirmed adenocarcinoma of the prostate Metastatic disease by conventional imaging PSA of more than or equal 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 Detailed eligibility criteria is available on ClinicalTrials.gov. These requirements will be discussed with your doctor and/or study representative. ClinicalTrials.gov to learn more about this study.
Protocol Number: 25-0680
More information available at ClinicalTrials.gov: NCT06592924
Principal Investigator