Docetaxel for Metastatic Prostate Cancer with Suboptimal PSA Response
This study is for men with metastatic castration-sensitive prostate cancer (mCSPC), meaning the cancer has spread but still responds to hormone therapy. You might be eligible if you've already been on hormone treatment (Androgen Deprivation Therapy or ADT) and an Androgen-Receptor Pathway Inhibitor (ARPI) like Abiraterone, Enzalutamide, Apalutamide, or Darolutamide for 6-12 months, but your PSA (prostate-specific antigen, a marker for prostate cancer) hasn't responded as well as hoped. The study wants to see if adding Docetaxel (a chemotherapy drug) to your current ADT and ARPI treatment improves overall survival compared to continuing with just ADT and ARPI. The study plans to enroll 830 participants and will track overall survival for 39 months.
- Study design
- This is an international, multi-center, open-label, randomized Phase III study. It compares two treatment approaches in about 830 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed to measure overall survival, with the primary measurement taken at 39 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06592924
Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response
Recruiting
PHASE3Ages 18+InterventionalTreatmentCanadian Cancer Trials GroupGovernment-funded
~830 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:AbirateroneEnzalutamideApalutamideDarolutamide (BAY 1841788)DocetaxelADT
At a glance
Recruiting sites
380 of 395 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival
Measured over 39 months
Conditions
Where it's being run
395 sites across 49 statesCalifornia50
Washington25
Michigan22
Colorado21
Minnesota21
Hawaii20
Ohio18
Iowa17
Study leadership
- Michael Ong · STUDY_CHAIR · Ottawa Hospital Research Institute, Ottawa ON Canada
- Alexandra Sokolova · STUDY_CHAIR · Oregon Health and Science University, Portland, OR, USA
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 \<1.7 nmol/L or 50 ng/dL.
PSA ≥ 0.2 ng/ml (0.2 ug/L) within 28 days of enrollment.
Candidate for docetaxel chemotherapy
ECOG Performance Status (PS) 0 to 2.
Adequate organ and marrow function measured within 28 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 10 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
Exclusion
Confirmed PSA progression, defined by an increase in PSA of 25% above the nadir since achieving castration on ADT, an absolute increase in PSA value of 2.0 ng/ml (ug/L) above nadir, and a subsequent increase in PSA of 25% further separated by 3 or more weeks.
Evidence of confirmed radiographic progression or clinical progression since start of ADT. Participants may be enrolled on the study if, in the opinion of the investigator, any new bone lesions on bone scan and CT represent flare or treatment effect.
Docetaxel criteria:
Prior treatment with taxane chemotherapy
Grade 2 or worse peripheral neuropathy
Severe hypersensitivity to drugs formulated with polysorbate 80
Clinically significant cardiac disease including:
History of unstable angina pectoris, symptomatic pericarditis, or myocardial infarction within 6 months prior to study entry.
History of documented congestive heart failure (New York Heart Association functions classification III-IV).
Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous.
Patients with a prior or concurrent malignancy whose natural history of treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Concurrent treatment with other anti-cancer systemic therapy other than ADT and ARPI.
Live attenuated vaccination administered within 30 days prior to enrollment/randomization.
For participants with a history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
High-grade neuroendocrine prostate cancer or small cell features (except if a participant has no histological diagnosis but a PSA \>100 ng/ml (\>100 ug/L) at diagnosis and radiographic evidence of metastatic disease)
What this trial measures
- Overall Survival39 months