Actively Recruiting

Phase 3
Age: 18Years +
MALE
NCT06439225

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

Led by Canadian Cancer Trials Group · Updated on 2026-04-16

236

Participants Needed

14

Research Sites

273 weeks

Total Duration

On this page

Sponsors

C

Canadian Cancer Trials Group

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologic diagnosis of prostate adenocarcinoma without neuroendocrine or small cell carcinoma
  • Prior treatment with androgen receptor pathway inhibitors such as abiraterone, enzalutamide, apalutamide, or darolutamide
  • Recovery to grade 1 or less from prior treatment toxicities except chemotherapy-induced hair loss and grade 2 peripheral neuropathy
  • Adequate washout periods from prior therapies according to specified timelines
  • Major surgery completed at least 28 days before enrollment with wound healing
  • Prior external beam radiation completed at least 7 days before enrollment
  • Radiologic evidence of metastatic disease within 28 days before randomization
  • Disease progression after androgen receptor pathway inhibitor therapy shown by PSA or radiographic criteria
  • Medical or surgical castration with testosterone levels below 50 ng/dL or 1.7 mmol/L
  • Presence of qualifying DNA damage response gene alterations of clinical significance, excluding monoallelic deletions
  • Age 18 years or older
  • ECOG Performance Status of 2 or less
  • Adequate organ and marrow function within 14 days before enrollment
  • Life expectancy longer than 12 weeks
  • Agreement to use medically accepted contraception during and for 6 months after treatment if of childbearing potential
  • Ability to complete quality of life questionnaires in English or French
  • Signed informed consent and availability for treatment and follow-up
  • Treatment to begin within 2 working days after enrollment
Not Eligible

You will not qualify if you...

  • Prior platinum or taxane chemotherapy for prostate cancer, except limited docetaxel after curative treatment for localized disease with at least 12 months since last treatment
  • Active anticancer systemic therapy or investigational agents within 14 days of randomization
  • Uncontrolled illnesses including active infection, severe heart failure, unstable angina, arrhythmias, uncontrolled hypertension, or psychiatric/social issues limiting compliance
  • Myelodysplastic syndrome or acute myeloid leukemia
  • Malignancy within past 2 years with high risk of recurrence except certain skin and bladder cancers
  • Symptomatic brain metastases, though stable treated asymptomatic metastases are allowed
  • Symptomatic or impending spinal cord compression unless treated and stable
  • Conditions that pose significant risk or interfere with study participation as judged by investigator
  • Live attenuated vaccine within 30 days prior to randomization
  • For HIV patients, undetectable viral load on therapy within 6 months
  • For hepatitis B or C, viral load control or cure with treatment
  • Inability to obtain provincial reimbursement for study drugs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada, T2N 5G2

Actively Recruiting

2

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Actively Recruiting

3

BCCA - Vancouver

Vancouver, British Columbia, Canada, V5Z 4E6

Actively Recruiting

4

William Osler Health System

Brampton, Ontario, Canada, L6R 3J7

Actively Recruiting

5

Waterloo Regional Health Network (WRHN)

Kitchener, Ontario, Canada, N2G 1G3

Actively Recruiting

6

London Health Sciences Centre Research Inc.

London, Ontario, Canada, N6A 5W9

Actively Recruiting

7

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

8

Odette Cancer Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

9

University Health Network

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

10

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada, H2X 3E4

Actively Recruiting

11

The Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

Actively Recruiting

12

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

Québec, Quebec, Canada, G1J 1Z4

Actively Recruiting

13

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada, S4T 7T1

Actively Recruiting

14

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada, S7N 4H4

Actively Recruiting

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Research Team

M

Mariam Jafri

CONTACT

W

Wendy Parulekar

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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