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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
830
Assigned prior to enrollment
Assigned prior to enrollment
Assigned prior to enrollment
Assigned prior to enrollment
Assigned at enrollment
Physician's choice. Assigned prior to enrollment
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
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Overall Survival
Time frame: 39 months
PSA Progression compared in both arms
Time frame: 39 months
PSA Response comparison between arms
PCWG3 criteria
Time frame: 39 months
PSA Kinetics compared between both arms
* 90% PSA decline * PSA \<0.2ng/ml * PSA \<0.02ng/ml
Time frame: 39 months
Clinical progression-free survival between both arms
Time frame: 39 months
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