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PARP Inhibitor and ATR Inhibitor

ATR + PARP Inhibitors for Prostate Cancer

Phase 2

Waitlist Available

Led By Zachery Reichert, M.D.

Research Sponsored by University of Michigan Rogel Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Progression of bidimensionally measurable soft tissue or nodal metastasis by CT or MRI based on RECIST, v1.1

Second generation anti-androgen (e.g. abiraterone, enzalutamide or apalutamide) within the hormone-sensitive phase of disease AND progression occurs while on therapy

Must not have

Uncontrolled hypertension (Grade 2 or above) requiring urgent (for example, adjusting medications within 24 hours) clinical intervention

A diagnosis of ataxia telangiectasia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after study completion (an average of 1 year for study completion)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new combination of drugs to treat prostate cancer that has spread and is resistant to hormone therapy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems, potential liver issues indicated by altered tests results; specific drug-related reactions are also possible but vary individually.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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My cancer has worsened despite low testosterone and previous treatments.

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My prostate cancer has spread, as shown on scans.

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I am a man aged 18 or older.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been diagnosed with ataxia telangiectasia.

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I have or had myelodysplastic syndrome or acute myeloid leukemia.

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

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

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

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

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

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

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

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

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I have previously been treated with drugs targeting DNA repair.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after study completion (an average of 1 year for study completion)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after study completion (an average of 1 year for study completion)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after study completion (an average of 1 year for study completion) for reporting.