Comparing Docetaxel with Carboplatin for metastatic castration-resistant prostate cancer

Inclusion

• +Histologic diagnosis of adenocarcinoma of the prostate. The presence of neuroendocrine or small cell carcinoma will be exclusionary
• +Prior treatment with any ARPI, such as abiraterone, enzalutamide, apalutamide, or darotlutamide, is required.
• +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
• +2 weeks, 5 half lives, or standard cycle length (whichever is longer) for investigational agents
• +Radiologically documented presence of metastatic disease within 28 days prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
• +Disease progression after ARPI therapy as assessed by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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 baselineBaselineYour starting measurements, taken before treatment begins.Read more →/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.
• +Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
• +Participants must have adequate organ and marrow function measured within 14 days prior to enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
• +Life expectancy \> 12 weeks.
• +Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and health utility questionnaires in either English or French
• +Participant consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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-upFollow-upContinued check-ins after the treatment part is finished.Read more →. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more →, and follow-up.
• +In accordance with CCTG policy, protocolProtocolThe detailed plan a study must follow.Read more → treatment is to begin within 2 working days after participant enrolment.
• +If the participant and the participant's partner are of childbearing potential, they must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 6 months after the last dose of study drug.
• +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 washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more → as follows:
• +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