Platinum and Taxane Chemo in Met Castration Resistant Prostate Cancer Patients With Alterations in DNA Damage Response Genes

NCT06439225 | Recruiting Phase 3 DMC

• 1 other identifier: PR25
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 14

Brief Summary

The usual approach for most patients who are not in a study is treatment with docetaxel. 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 approach? This study is being done to find out if this approach is better or worse than the usual approach for prostate cancer. The usual approach is defined as the care most people get for prostate cancer.

Conditions

Metastatic Castration-resistant Prostate Cancer; Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  5.25 years

Secondary Outcomes (9)

• To compare the two treatment arms with respect to PSA response

  5.25 years

• To compare the two treatment arms with respect to progression free survival

  5.25 years

• To compare the two treatment arms with respect to time to next systemic therapy

  5.25 years

• To compare the two treatment arms with respect to time to number and severity of adverse events

  5.25 years

• To compare the two treatment arms with respect to patient-reported Quality of Life (QoL) quantified by FACT-P questionnaire

  5.25 years

Study Arms (2)

Docetaxel

ACTIVE COMPARATOR

Drug: Docetaxel

Carboplatin + Docetaxel

EXPERIMENTAL

Drug: Docetaxel; Drug: Carboplatin

Interventions

Docetaxel DRUG

75mg/m2 q21 days

Carboplatin + Docetaxel; Docetaxel

Carboplatin DRUG

AUC5 q21 days

Carboplatin + Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior treatment with any ARPI, such as abiraterone, enzalutamide, apalutamide, or darotlutamide, is required.
• Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior systemic or radiation therapy, with the exception of chemotherapy induced alopecia and grade 2 peripheral neuropathy, and have adequate washout as follows:
• Longest of one of the following:
• Two weeks for oral therapies (such as abiraterone, apalutamide, enzalutamide, darolutamide and olaparib)
• Standard cycle of standard IV or IM therapies (such as radium 223 or Lu-177-PSMA-617
• weeks, 5 half lives, or standard cycle length (whichever is longer) for investigational agents
• Previous major surgery is permitted provided that surgery occurred at least 28 days prior to participant enrollment and that wound healing has occurred
• Prior external beam radiation is permitted provided a minimum of 7 days have elapsed between the last dose of radiation and date of enrollment
• Radiologically documented presence of metastatic disease within 28 days prior to randomization
• Disease progression after ARPI therapy as assessed by the investigator with at least one of the following:
• PSA progression with a minimum of two rising PSA values at least 1 week apart, at least 25% and 2ug/L above baseline/nadir.
• Radiographic progression of soft tissue disease by RECIST 1.1 criteria or bone metastases by PCWG3 criteria.
• Medical or surgical castration with serum testosterone levels \<50ng/dL or \<1.7mmol/L
• Qualifying Tier I or Tier II (clinically significant/likely clinically significant or pathogenic / likely pathogenic) germline or somatic alterations involving one or more of the following DDR genes: BRCA1, BRCA2, ATM, ATR, BRIP1, BARD1, CDK12, CHEK1, CHEK2, ERCC2, FANCA, FANCC, FANCD2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L. Monoallelic gene deletions in isolation will not be eligible.
• Age 18 years or older.

You may not qualify if:

• Received prior platinum chemotherapy (i.e. carboplatin, cisplatin, oxaliplatin, satraplatin) or prior taxane chemotherapy (docetaxel, paclitaxel, cabazitaxel) at any time for the treatment of prostate cancer with the exception of docetaxel for mCSPCor adjuvant therapy after curative intent treatment for localized prostate cancer, as long as it was no more than 6 cycles and at least 12 months have elapsed from their last treatment to the date of enrollment. If the participant received prior platinum or taxane chemotherapy for other cancers, then please contact the CCTG office to discuss this further with the trial team.
• Active anticancer systemic therapy or investigational agents within 14 days of randomization.
• Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure (NYHA Class III or IV heart disease), unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements.
• Participants with myelodysplastic syndrome/acute myeloid leukemia.
• Malignancy within the previous 2-years with a \> 30% probability of recurrence within 12 months, with the exception of non-melanoma skin cancer, and in-situ or superficial bladder cancer.
• Participants with known symptomatic brain metastasis. However, participants with asymptomatic, treated brain metastases that have been stable for at least 12 weeks are eligible for study entry.
• Participants with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable and asymptomatic.
• Presence of a condition or situation, which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with participation in the study.
• Live attenuated vaccination administered within 30 days prior to randomization.
• For patients with known immunodeficiency virus (HIV) infection, the HIV viral load must be undetectable on effective anti-retroviral therapy within 6 months of enrollment.
• For participants with evidence 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.
• Unable to obtain provincial reimbursement of carboplatin and docetaxel

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (14)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

RECRUITING

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

BCCA - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

William Osler Health System

Brampton, Ontario, L6R 3J7, Canada

RECRUITING

Waterloo Regional Health Network (WRHN)

Kitchener, Ontario, N2G 1G3, Canada

RECRUITING

London Health Sciences Centre Research Inc.

London, Ontario, N6A 5W9, Canada

RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

The Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)

Québec, Quebec, G1J 1Z4, Canada

RECRUITING

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

RECRUITING

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Carboplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Michael Kolinsky

  Cross Cancer Institute, Edmonton, Alberta, Canada

  STUDY CHAIR

Central Study Contacts

Mariam Jafri

CONTACT

613-533-6430; mjafri@ctg.queensu.ca

Wendy Parulekar

CONTACT

613-533-6430; wparulekar@ctg.queensu.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 3, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): March 31, 2030
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (14)