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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I've had treatment for prostate cancer that's now resistant to hormone therapy.
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I stopped my previous cancer therapy 3 weeks ago but may still be on prednisone.
Select...
My cancer has worsened despite low testosterone and previous treatments.
Select...
My prostate cancer has spread, as shown on scans.
Select...
I have been mostly active and able to carry out all my pre-disease activities up to 42 days before signing up.
Select...
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.
Select...
I have received one treatment for metastatic castration-resistant prostate cancer.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of response (Complete Response [CR] or Partial Response [PR]) in DNA repair proficient (DRPro) patients
Secondary outcome measures
Adverse Events
Duration of combined radiographic and PSA response in DRDef patients
Duration of combined radiographic and PSA response in DRPro patients
+10 moreTrial Design
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140
AZD6738
2015
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
293 Previous Clinical Trials
24,048 Total Patients Enrolled
28 Trials studying Prostate Cancer
2,937 Patients Enrolled for Prostate Cancer
Zachery Reichert, M.D.Principal InvestigatorUniversity of Michigan Rogel Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on hormone therapy for cancer and my testosterone is very low.My cancer has grown or spread, as shown by recent scans.Your PSA levels have been continuously increasing for at least a week and started at a minimum of 1.0 ng/mL.I have taken medication like abiraterone for my cancer, but it's still getting worse.I can swallow pills and don't have serious stomach or bowel issues affecting medication absorption.I don't have active brain cancer, but if I had it before, it's now stable and I've finished all treatments for it over 3 weeks ago.I've had treatment for prostate cancer that's now resistant to hormone therapy.I agree to a biopsy for DNA repair status, or I have prior DNA sequencing results.I have had episodes of fainting or near-fainting not caused by reversible reasons.I agree to use barrier contraception during the study and for some time after.My high blood pressure is severe and needs quick medication changes.I have been diagnosed with ataxia telangiectasia.Your doctor thinks you will live for at least 16 more weeks.I haven't had any cancer except for skin cancer or early bladder cancer in the last 3 years.It has been over 21 days since my last palliative radiation, except for certain types where it's been over 28 days.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 stopped my previous cancer therapy 3 weeks ago but may still be on prednisone.I am not allergic to olaparib, AZD6738, or their ingredients.My cancer has worsened despite low testosterone and previous treatments.I have not had serious heart issues in the last 6 months.My prostate cancer has spread, as shown on scans.My blood, liver, and kidney functions are within normal ranges as tested recently.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.I don't have lasting side effects from cancer treatment, except for hair loss or mild nerve pain.I have been mostly active and able to carry out all my pre-disease activities up to 42 days before signing up.I am a man aged 18 or older.My prostate cancer is confirmed not to be small-cell or neuroendocrine type.I am willing and able to follow the study's requirements, including biopsies, treatments, and visits.I have received one treatment for metastatic castration-resistant prostate cancer.My heart's electrical activity is normal and I don't have low blood pressure or sudden drops when standing.You must agree to participate in the study before any procedures can be done.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 (DRPro)
- Group 2: Cohort 2 (DRDef)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment a new endeavor?
"Since its initial study in 2005, sponsored by AstraZeneca and involving 98 participants, AZD6738 has been trialed extensively. Ultimately leading to Phase 1 drug approval, there are now 199 active trials for this medication across 59 nations and 1472 cities."
Answered by AI
How many participants are engaged in this experiment?
"At this time, the clinical trial is not open for enrollment. It was originally published on October 31st 2019 and last edited on July 18th 2022. For those seeking alternative studies, there are 1315 trials actively recruiting prostate cancer participants and 199 involving AZD6738 that have opened their doors to volunteers."
Answered by AI
What medical conditions have been found to be treatable with AZD6738?
"AZD6738 is a potential medication for those facing advance directives, malignant neoplasm of the ovary or primary peritoneal cancer."
Answered by AI
To what degree is AZD6738 a safe intervention for patients?
"With only preliminary data regarding its safety, AZD6738 received a score of 2. There is currently no evidence suggesting it's efficacy."
Answered by AI
Has AZD6738 been subject to other research projects?
"At present, 199 scientific investigations are being conducted into AZD6738 with 27 of those studies in the advanced Phase 3. Although Houston is the main hub for researching this therapy, there are a total of 9407 locations running experiments on it."
Answered by AI
Are there currently any open slots for participants in this clinical research?
"Clinicaltrials.gov data confirms that this specific trial is not currently recruiting patients, as the last modification was made on July 18th 2022. However, there are 1,514 alternative studies actively enrolling participants at present."
Answered by AI
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