ATR + PARP Inhibitors for Prostate Cancer

Palo Alto (17 mi)

Dr. Zachery R. Reichert, MD | Ann Arbor ...

Overseen byZachery R. Reichert

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Michigan Rogel Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to test the effectiveness (how well the drugs work), safety, and tolerability of the investigational drug combination of olaparib and AZD6738 for all patients with metastatic castration-resistant prostate cancer.

Eligibility Criteria

Men over 18 with advanced prostate cancer that's resistant to castration and has spread, showing progression despite hormone therapy. They must have good performance status, adequate organ function, agree to use contraception, and not have had certain treatments or conditions that could interfere with the trial.

Inclusion Criteria

My cancer has grown or spread, as shown by recent scans.

I have taken medication like abiraterone for my cancer, but it's still getting worse.

I've had treatment for prostate cancer that's now resistant to hormone therapy.

My cancer has worsened despite low testosterone and previous treatments.

My prostate cancer has spread, as shown on scans.

I am a man aged 18 or older.

My prostate cancer is confirmed not to be small-cell or neuroendocrine type.

I have received one treatment for metastatic castration-resistant prostate cancer.

Exclusion Criteria

My high blood pressure is severe and needs quick medication changes.

I have been diagnosed with ataxia telangiectasia.

I have or had myelodysplastic syndrome or acute myeloid leukemia.

I haven't taken certain cancer drugs for at least 21 days or 5 half-lives before starting the new treatment.

I had major surgery more than 2 weeks ago and have recovered.

I have stopped taking certain medications that affect liver enzymes as required before starting treatment.

I am not allergic to olaparib, AZD6738, or their ingredients.

I have not had serious heart issues in the last 6 months.

I have not had a live vaccine in the last 2 weeks.

I haven't had a whole blood transfusion in the last 4 months.

I have had a bone marrow or cord blood transplant in the past.

I have previously been treated with drugs targeting DNA repair.

Treatment Details

The TRAP Trial is testing a combination of two drugs, Olaparib and AZD6738, for their effectiveness in treating metastatic castration-resistant prostate cancer. The study will assess how well these drugs work together and monitor patients' safety and tolerance to this treatment regimen.

2Treatment groups

Experimental Treatment

Group I: Cohort 2 (DRDef)Experimental Treatment2 Interventions

Patients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair deficient (DRDef).

Group II: Cohort 1 (DRPro)Experimental Treatment2 Interventions

Patients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair proficient (DRPro).