Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Immunotherapy + Radiation ± PARP Inhibitor for Prostate Cancer
Phase 2
Recruiting
Led By Zin W Myint, MD
Research Sponsored by Zin W Myint
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial will evaluate whether immunotherapy and radiation with or without a PARP-inhibitor will increase the effects of immunotherapy in men with high-risk localized prostate cancer.
Who is the study for?
Men with high-risk localized prostate cancer who meet specific health criteria can join this trial. They must have a certain level of physical fitness, no large pelvic nodes as per CT scans, and agree to use contraception post-treatment. Those with PSA levels over 150ng/ml, extensive prior hormone therapy or radiation to the prostate, other cancers within 2 years, or recent anti-cancer treatments cannot participate.Check my eligibility
What is being tested?
The study is testing if combining Pembrolizumab (an immunotherapy drug) and radiation therapy improves treatment outcomes in these patients. Some will also receive Olaparib (a PARP-inhibitor) to see if it boosts the immune system's response when added to the mix.See study design
What are the potential side effects?
Possible side effects include fatigue, skin reactions from radiation, immune-related conditions like inflammation in organs due to Pembrolizumab, and gastrointestinal issues or blood cell changes from Olaparib.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Response Rate
Secondary outcome measures
Biochemical-Free Survival
Metastasis-Free Survival
Molecular Alterations in Homologous Recombination Repair Genes
+1 moreOther outcome measures
Cytokine
Correlation between clinical outcome and immune cell subtype.
Correlation between clinical outcomes and TCR repertories clonotypes.
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2 - PembrolizumabExperimental Treatment3 Interventions
Patients with high-risk prostate cancer receiving combination therapy with Pembrolizumab.
Group II: Arm 1 - Pembrolizumab and OlaparibExperimental Treatment4 Interventions
Patients with high-risk prostate cancer receiving combination therapy with Pembrolizumab and Olaparib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Olaparib
2007
Completed Phase 4
~2140
Radiation Therapy
2017
Completed Phase 3
~7250
Androgen Deprivation Therapy
2008
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,082 Total Patients Enrolled
26 Trials studying Prostate Cancer
16,933 Patients Enrolled for Prostate Cancer
Zin W MyintLead Sponsor
2 Previous Clinical Trials
51 Total Patients Enrolled
2 Trials studying Prostate Cancer
51 Patients Enrolled for Prostate Cancer
Zin W Myint, MDPrincipal InvestigatorUniversity of Kentucky
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My pelvic nodes are not larger than 2 cm as shown by a CT scan.I have had radiation treatment on my prostate before.I am fully active or can carry out light work.My organs and bone marrow are working well.I have been on hormone therapy for prostate cancer for over 90 days.I have a history of ulcerative proctitis.I have had major pelvic surgery or radiation therapy before.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.My cancer has spread to distant parts of my body.My condition is considered high-risk according to NCCN guidelines.I stopped taking medication for prostate enlargement at least 60 days ago.I am a man diagnosed with prostate cancer.I started hormone therapy for prostate cancer less than 90 days ago.I have not had another type of cancer in the last 2 years.I have a heart condition or have been treated with heart-affecting drugs and need a heart function assessment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 - Pembrolizumab and Olaparib
- Group 2: Arm 2 - Pembrolizumab
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.
Are there currently any openings for enrolment in this clinical trial?
"The findings on clinicaltrials.gov report that this particular medical trial, which was first posted in January 2nd 2023 and last updated October 3rd 2022, is not presently enrolling participants. Nevertheless there are 1,315 other trials actively recruiting right now."
Answered by AI
Has the joint usage of pembrolizumab and olaparib been ratified by the Food and Drug Administration?
"The safety of Arm 1 - Pembrolizumab and Olaparib has been assessed at 2, as the Phase 2 trial does not yet have any evidence-based data to support efficacy."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger