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
Canadian Cancer Trials Group
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).
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.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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…
Interventions
- DrugAbiraterone
Assigned prior to enrollment
- DrugEnzalutamide
Assigned prior to enrollment
- DrugApalutamide
Assigned prior to enrollment
- DrugDarolutamide (BAY 1841788)
Assigned prior to enrollment
- DrugDocetaxel
Assigned at enrollment
- DrugADT
Physician's choice. Assigned prior to enrollment
Locations (340)
- Anchorage Associates in Radiation MedicineAnchorage, Alaska
- Alaska Breast Care and Surgery LLCAnchorage, Alaska
- Alaska Oncology and Hematology LLCAnchorage, Alaska
- Alaska Women's Cancer CareAnchorage, Alaska
- Katmai Oncology GroupAnchorage, Alaska
- Providence Alaska Medical CenterAnchorage, Alaska