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NCT06592924

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

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

830 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-28

Study Completion Date

2031-04-15

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Prostate Cancer (Adenocarcinoma)

Keywords

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PR26 Castration sensitive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard ADT + ARPI

Group Type ACTIVE_COMPARATOR

Abiraterone

Intervention Type DRUG

Assigned prior to enrollment

Enzalutamide

Intervention Type DRUG

Assigned prior to enrollment

Apalutamide

Intervention Type DRUG

Assigned prior to enrollment

Darolutamide (BAY 1841788)

Intervention Type DRUG

Assigned prior to enrollment

ADT

Intervention Type DRUG

Physician's choice. Assigned prior to enrollment

Docetaxel + Standard ADT + ARPI

Group Type EXPERIMENTAL

Abiraterone

Intervention Type DRUG

Assigned prior to enrollment

Enzalutamide

Intervention Type DRUG

Assigned prior to enrollment

Apalutamide

Intervention Type DRUG

Assigned prior to enrollment

Darolutamide (BAY 1841788)

Intervention Type DRUG

Assigned prior to enrollment

Docetaxel

Intervention Type DRUG

Assigned at enrollment

ADT

Intervention Type DRUG

Physician's choice. Assigned prior to enrollment

Interventions

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Abiraterone

Assigned prior to enrollment

Intervention Type DRUG

Enzalutamide

Assigned prior to enrollment

Intervention Type DRUG

Apalutamide

Assigned prior to enrollment

Intervention Type DRUG

Darolutamide (BAY 1841788)

Assigned prior to enrollment

Intervention Type DRUG

Docetaxel

Assigned at enrollment

Intervention Type DRUG

ADT

Physician's choice. Assigned prior to enrollment

Intervention Type DRUG

Eligibility Criteria

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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 testosterone \<1.7 nmol/L or 50 ng/dL.
* PSA ≥ 0.2 ng/ml (0.2 ug/L) within 14 days of enrollment. If there is any rise in PSA since starting ADT and achieving castrate-level testosterone, PSA must be repeated and must not fulfill ineligibility criteria 4.2.1.
* Candidate for docetaxel chemotherapy
* ECOG Performance Status (PS) 0 to 2.
* Adequate organ and marrow function measured within 14 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 5 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 Criteria

* Two consecutive rises in PSA since achieving castration on ADT at least 2 weeks apart with at least one PSA ≥5% above the PSA nadir and with at least one PSA having an absolute increase of ≥0.5 ng/ml above the PSA nadir.
* Evidence of radiographic progression or clinical progression since start of ADT.
* Docetaxel criteria:

* Prior treatment with taxane chemotherapy
* Grade 2 or worse peripheral neuropathy
* Severe hypersensitivity to drugs formulated with polysorbate 80
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better.
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Ong

Role: STUDY_CHAIR

Ottawa Hospital Research Institute, Ottawa ON Canada

Alexandra Sokolova

Role: STUDY_CHAIR

Oregon Health and Science University, Portland, OR, USA

Locations

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Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

Site Status RECRUITING

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Site Status RECRUITING

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Site Status RECRUITING

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Site Status RECRUITING

Katmai Oncology Group

Anchorage, Alaska, United States

Site Status RECRUITING

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status RECRUITING

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Site Status RECRUITING

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

Site Status RECRUITING

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Site Status RECRUITING

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Site Status RECRUITING

Mercy San Juan Medical Center

Carmichael, California, United States

Site Status RECRUITING

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status RECRUITING

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Site Status RECRUITING

City of Hope at Irvine Lennar

Irvine, California, United States

Site Status RECRUITING

City of Hope Antelope Valley

Lancaster, California, United States

Site Status RECRUITING

City of Hope at Long Beach Elm

Long Beach, California, United States

Site Status RECRUITING

Los Angeles General Medical Center

Los Angeles, California, United States

Site Status RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Mercy Cancer Center

Merced, California, United States

Site Status RECRUITING

Providence Queen of The Valley

Napa, California, United States

Site Status RECRUITING

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

Site Status RECRUITING

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Site Status RECRUITING

VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status RECRUITING

Keck Medical Center of USC Pasadena

Pasadena, California, United States

Site Status RECRUITING

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Site Status RECRUITING

Mercy Cancer Center - Sacramento

Sacramento, California, United States

Site Status RECRUITING

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Site Status RECRUITING

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Site Status RECRUITING

Providence Medical Foundation - Santa Rosa

Santa Rosa, California, United States

Site Status RECRUITING

Providence Santa Rosa Memorial Hospital

Santa Rosa, California, United States

Site Status RECRUITING

City of Hope South Pasadena

South Pasadena, California, United States

Site Status RECRUITING

Saint Joseph's Medical Center

Stockton, California, United States

Site Status RECRUITING

City of Hope South Bay

Torrance, California, United States

Site Status RECRUITING

City of Hope Upland

Upland, California, United States

Site Status RECRUITING

Woodland Memorial Hospital

Woodland, California, United States

Site Status RECRUITING

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Site Status RECRUITING

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Site Status RECRUITING

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Site Status RECRUITING

Memorial Hospital North

Colorado Springs, Colorado, United States

Site Status RECRUITING

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

Site Status RECRUITING

UCHealth - Cherry Creek

Denver, Colorado, United States

Site Status RECRUITING

Dillon Health Center/Shaw Cancer Center

Dillon, Colorado, United States

Site Status RECRUITING

CommonSpirit Cancer Center Mercy

Durango, Colorado, United States

Site Status RECRUITING

Mercy Medical Center

Durango, Colorado, United States

Site Status RECRUITING

Shaw Cancer Center

Edwards, Colorado, United States

Site Status RECRUITING

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, United States

Site Status RECRUITING

Saint Anthony Hospital

Lakewood, Colorado, United States

Site Status RECRUITING

UCHealth Lone Tree Health Center

Lone Tree, Colorado, United States

Site Status RECRUITING

Longmont United Hospital

Longmont, Colorado, United States

Site Status RECRUITING

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Site Status RECRUITING

Saint Anthony North Hospital

Westminster, Colorado, United States

Site Status RECRUITING

Beebe Medical Center

Lewes, Delaware, United States

Site Status RECRUITING

Beebe South Coastal Health Campus

Millville, Delaware, United States

Site Status RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status RECRUITING

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status RECRUITING

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Site Status RECRUITING

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Site Status RECRUITING