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PARP Inhibitor
CJNJ-67652000 + Prednisone for Prostate Cancer
Phase 2
Recruiting
Led By Alan H Bryce
Research Sponsored by Mayo Clinic
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 from registration to the earliest date of documentation of progression, assessed up to 2 years
Awards & highlights
Study Summary
This trial tests a drug combo to treat metastatic prostate cancer with SPOP gene mutation. Drug combo stops cancer cells from repairing, prednisone reduces inflammation & immune response. May kill more tumor cells than either alone.
Who is the study for?
Men aged 18+ with advanced prostate cancer resistant to castration and spread beyond the original site, having specific SPOP gene mutations. They can have had one prior chemotherapy but must be in relatively good health (ECOG status 0-2) with adequate blood counts and organ function. Men must agree not to donate sperm and use contraception during the trial.Check my eligibility
What is being tested?
The effectiveness of CJNJ-67652000 (a combination of niraparib/abiraterone acetate) alongside prednisone is being tested for treating metastatic castration-resistant prostate cancer with SPOP mutations. The study will assess if this drug combo kills more tumor cells compared to standard treatments.See study design
What are the potential side effects?
Potential side effects include those typical of cancer therapies such as fatigue, digestive issues, changes in blood counts leading to increased infection risk, possible liver or kidney function changes, and reactions related to steroid use like increased blood sugar levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from registration to the earliest date of documentation of progression, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from registration to the earliest date of documentation of progression, assessed up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prostate specific antigen (PSA) response rate (PSA decline by >= 50% [PSA50])
Secondary outcome measures
Incidence of adverse events
Radiologic progression-free survival (rPFS)
Time to progression
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (CJNJ-67652000 and prednisone)Experimental Treatment6 Interventions
Patients receive CJNJ-67652000 PO and prednisone PO on study. Patients also undergo blood specimen collection, CT or MRI, and bone scan throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2370
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,458 Total Patients Enrolled
34 Trials studying Prostate Cancer
8,388 Patients Enrolled for Prostate Cancer
Alan H BrycePrincipal InvestigatorMayo Clinic
Daniel S. Childs, MDPrincipal InvestigatorMayo Clinic in Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases that are causing symptoms.I do not have any unmanaged ongoing illnesses.I have had recent surgery or chemotherapy.I have been diagnosed with a type of blood cancer or myelodysplastic syndrome.I have been treated with PARP inhibitors or platinum-based chemotherapy.I cannot take prednisone or need high doses of steroids due to my medical condition.My cancer has a specific SPOP mutation.I have had only one prior treatment with taxane chemotherapy.I am able to care for myself and perform daily activities.My blood count and liver function meet the required levels.I will use birth control during and after my treatment.My prostate cancer has spread and is not responding to hormone therapy.I have not had any other cancer in the last 3 years.My prostate cancer is confirmed to be adenocarcinoma.I have had a heart attack in the last 6 months.I am a man aged 18 or older.My cancer has worsened despite hormone therapy and one other treatment.My testosterone levels are 50 ng/dL or lower after castration.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (CJNJ-67652000 and prednisone)
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.
Does the FDA recognize CJNJ-67652000 and prednisone as a valid treatment option?
"Based on the available clinical data, our team at Power has judged Treatment (CJNJ-67652000 and prednisone) to be a 2 in terms of safety. This is due to it being a Phase 2 trial, with evidence for safety but not efficacy."
Answered by AI
Is registration for this experiment currently open?
"Confirmed. The medical trial, which was first posted on March 1st 2023 and most recently updated on January 9th of the same year, is not currently looking for volunteers. Nevertheless, there are a plethora of other clinical trials enrolling patients at this time with 1241 being listed online."
Answered by AI
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