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.
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.
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
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.
Parallel
Docetaxel
Drug75mg/m2 q21 days
Carboplatin
DrugAUC5 q21 days
Overall Survival
To compare the two treatment arms with respect to PSA response
Defined as a reduction in PSA from baseline by 50%
To compare the two treatment arms with respect to progression free survival
as defined by PCWG3 and RECIST 1.1
To compare the two treatment arms with respect to time to next systemic therapy
To compare the two treatment arms with respect to time to number and severity of adverse events
Utilizing CTCAE version 5.0
Click on the lead sponsor to view all of their trials.
Canadian Cancer Trials Group
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
