Platinum and Taxane Chemo in Met Castration Resistant Prostate Cancer Patients With Alterations i… (NCT06439225) | Clinical Trial Compass
RecruitingPhase 3
Platinum and Taxane Chemo in Met Castration Resistant Prostate Cancer Patients With Alterations in DNA Damage Response Genes
Canada236 participantsStarted 2024-12-30
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* 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.
* 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
* 2 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 pr…