Platinum and Taxane Chemo for Prostate Cancer (OPTION-DDR Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Canadian Cancer Trials Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for men with advanced prostate cancer that has spread and doesn't respond to hormone therapy. They must have had prior treatment with drugs like abiraterone or enzalutamide, no small cell carcinoma presence, and be past major surgeries by at least 28 days. Men can't join if they've taken investigational agents recently or have certain types of neuroendocrine tumors.

Inclusion Criteria

My prostate cancer is adenocarcinoma without any neuroendocrine or small cell features.

I have been treated with medications like abiraterone or enzalutamide before.

I have not started any new treatments in the last two weeks.

I have waited long enough since my last experimental treatment.

My PSA levels have increased by at least 25% and 2ug/L from the lowest point, with two tests a week apart.

My cancer has spread to my bones or soft tissues, as confirmed by scans.

Treatment Details

The study tests whether adding Carboplatin to the usual Docetaxel chemotherapy lowers the chance of prostate cancer growing or spreading. It compares this combination against the standard treatment alone to see which is more effective in controlling the disease.

2Treatment groups

Experimental Treatment

Active Control

Group I: Carboplatin + DocetaxelExperimental Treatment2 Interventions

Group II: DocetaxelActive Control1 Intervention

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: