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RECRUITING

NCT06592924

PHASE3

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

Sponsor: Canadian Cancer Trials Group

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

830

Start Date

2025-05-28

Completion Date

2031-04-15

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Prostate Cancer (Adenocarcinoma)

Interventions

DRUG

Abiraterone

Assigned prior to enrollment

DRUG

Enzalutamide

Assigned prior to enrollment

DRUG

Apalutamide

Assigned prior to enrollment

DRUG

Darolutamide (BAY 1841788)

Assigned prior to enrollment

DRUG

Docetaxel

Assigned at enrollment

DRUG

ADT

Physician's choice. Assigned prior to enrollment

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.

Locations (310)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Katmai Oncology Group

Anchorage, Alaska, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

City of Hope Antelope Valley

Lancaster, California, United States

City of Hope at Long Beach Elm

Long Beach, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Mercy Cancer Center

Merced, California, United States

Providence Queen of The Valley

Napa, California, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

VA Palo Alto Health Care System

Palo Alto, California, United States

Keck Medical Center of USC Pasadena

Pasadena, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Providence Medical Foundation - Santa Rosa

Santa Rosa, California, United States

Providence Santa Rosa Memorial Hospital

Santa Rosa, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

Saint Joseph's Medical Center

Stockton, California, United States

City of Hope South Bay

Torrance, California, United States

City of Hope Upland

Upland, California, United States

Woodland Memorial Hospital

Woodland, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Memorial Hospital North

Colorado Springs, Colorado, United States

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

UCHealth - Cherry Creek

Denver, Colorado, United States

Dillon Health Center/Shaw Cancer Center

Dillon, Colorado, United States

CommonSpirit Cancer Center Mercy

Durango, Colorado, United States

Mercy Medical Center

Durango, Colorado, United States

Shaw Cancer Center

Edwards, Colorado, United States

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

UCHealth Lone Tree Health Center

Lone Tree, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Saint Anthony North Hospital

Westminster, Colorado, United States

Beebe Medical Center

Lewes, Delaware, United States

Beebe South Coastal Health Campus

Millville, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Springs

Coral Springs, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, United States

UM Sylvester Comprehensive Cancer Center at Hollywood

Hollywood, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

North Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Grady Health System

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Atlanta VA Medical Center

Decatur, Georgia, United States

Emory Decatur Hospital

Decatur, Georgia, United States

Emory Johns Creek Hospital

Johns Creek, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza