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

About This Trial

This study is testing whether adding a chemotherapy drug to standard hormone therapy works better to control advanced prostate cancer than hormone therapy alone.
It is designed for men whose prostate cancer has spread and who are already taking standard hormone medications, but whose PSA blood levels have not dropped low enough.
To join, you must have been on your current hormone treatments for several months without your cancer worsening, and you must not have had previous chemotherapy for this condition.
Before considering this trial, you should know that it involves receiving chemotherapy and that you must be healthy enough to tolerate its potential side effects and attend regular clinic visits.

More Information

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).

Who Can Enroll

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study is testing whether adding a chemotherapy drug to standard hormone therapy works better to control advanced prostate cancer than hormone therapy alone.

Study Details

Start Date: May 28, 2025
Lead Sponsor: Canadian Cancer Trials Group

Full Eligibility Criteria

Inclusion Criteria

Histologically/cytologically confirmed adenocarcinoma of the prostate or participants with a PSA >100 ng/ml (100 ug/L) and radiographic evidence of metastatic disease at diagnosis.
Metastatic disease by conventional imaging (bone scan or CT and/or MRI or PSMA-PET scan at the time of ADT initiation.
PSA of ≥ 2.0 ng/ml (2.0 ug/L) prior to commencement of ADT (this refers to patients who have histologically/cytologically confirmed adenocarcinoma of the prostate)
Patients will have recovered from any treatment-related toxicities prior to enrollment (unless ≤ grade 1, irreversible, or considered by investigator as not clinically significant).
Patients may enroll with persistent toxicities attributable to ADT, including hot flushes and fatigue, of any grade, provided these toxicities are clinically stable, not rapidly worsening, and not considered by the Investigator to pose a safety risk or impair the patient's ability to comply with study procedures. Such toxicities do not need to resolve to Grade ≤1 prior to study entry.
Receipt of ADT for mCSPC for at least 6 months and no greater than 12 months (+/- 3 weeks) at time of enrollment.
Receipt of ARPI (e.g. abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for at least 4 months (+/- 2 weeks) at time of enrollment
Patients may have had radiotherapy to prostatic bed and/or metastatic sites prior to enrollment. Potential trial participants should have recovered from radiotherapy-related toxicities prior to enrollment.
Serum testosterone 100 ng/ml (>100 ug/L) at diagnosis and radiographic evidence of metastatic disease)