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Hormone Therapy
Neoadjuvant PARP Inhibition + Hormone Therapy for Prostate Cancer (NePtune Trial)
Phase 2
Recruiting
Led By Rana R. McKay, MD
Research Sponsored by Rana McKay, MD
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 4 years
Awards & highlights
NePtune Trial Summary
This trial tests a drug+hormone combo to treat prostate cancer in men with genetic mutations. After 6 mo. of treatment, patients will have surgery to remove cancer and be followed for recovery & progression.
Who is the study for?
Men over 18 with intermediate to high-risk localized prostate cancer and confirmed BRCA1/2 gene mutations, who are candidates for radical prostatectomy. They must not have had certain hormone therapies or chemotherapy for prostate cancer, no prior PARP inhibitors, and no severe health issues like heart disease or uncontrolled infections.Check my eligibility
What is being tested?
The trial is testing the combination of olaparib (a PARP inhibitor) and an LHRH agonist given before surgery to remove the prostate in men with specific genetic changes linked to higher risk of aggressive cancer. The treatment lasts 6 months followed by surgery and evaluation of recovery.See study design
What are the potential side effects?
Olaparib may cause nausea, vomiting, fatigue, anemia, blood clots, shortness of breath; LHRH agonists can lead to hot flashes, sexual dysfunction. Side effects vary per individual based on their overall health and reaction to these medications.
NePtune Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Minimal Residual Disease (MRD) rate
Inverse PCR
Secondary outcome measures
Assess Cardiovascular Adverse Events
Assess adverse events
Evaluate changes in Prostate specific antigen (PSA)
+7 moreNePtune Trial Design
1Treatment groups
Experimental Treatment
Group I: Investigational GroupExperimental Treatment2 Interventions
300 mg of olaparib taken orally twice a day for 6 cycles (approximately 6 months). There are 30 days in a cycle.
Olaparib will be taken with an LHRH agonist (leuprolide, triptorelin, or goserlin). This choice of therapy will be taken for a total of 180 days per institutional standards.
After 6 cycles of neoadjuvant therapy, patients will undergo a radical prostatectomy (RP). After RP, patients will be followed for testosterone recovery and PSA progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140
LHRH agonist
2000
Completed Phase 4
~2420
Find a Location
Who is running the clinical trial?
Rana McKay, MDLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,271 Previous Clinical Trials
288,613,328 Total Patients Enrolled
59 Trials studying Prostate Cancer
27,490 Patients Enrolled for Prostate Cancer
University of California, San DiegoOTHER
1,121 Previous Clinical Trials
1,521,393 Total Patients Enrolled
6 Trials studying Prostate Cancer
1,238 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer is at an early to intermediate stage.I am currently on medication for an infection.I have been treated with a PARP inhibitor before.My scans show no cancer spread, and my lymph nodes are small.I have prostate cancer with a high Gleason score, high PSA, or T3 disease.I've had a prostate biopsy with cancer in at least 3 samples, or I have advanced prostate cancer on an MRI.I have been mostly active and able to carry on all pre-disease activities without restriction in the last 28 days.I understand and can follow the study's procedures.I am 18 years old or older.My cancer has a BRCA1 or BRCA2 gene mutation.My prostate cancer is mainly adenocarcinoma, with no major variants.I am eligible for prostate removal surgery as per my doctor's evaluation.I use more than 10 mg of prednisone daily for a chronic condition, but I can use replacement therapies.I do not have any current severe infections, liver problems, or issues that prevent me from taking pills.My blood tests and organ functions are within the required ranges.I haven't had hormone or radiation therapy for prostate cancer, except for short-term bicalutamide or LHRH treatments.I will use recommended birth control methods during and for 3 months after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational Group
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 any open slots for those wishing to partake in this investigation?
"Affirmative, this trial is actively recruiting as indicated on clinicaltrials.gov. The listing initially appeared on February 1st 2023 and was updated most recently on the 2nd of February that same year."
Answered by AI
What security protocols are in place to protect participants of the Investigational Group?
"Our team has cautiously appraised the Investigational Group's safety with a score of 2, since this is still an early stage study with limited data indicating its efficacy."
Answered by AI
What is the total participant count for this research project?
"Affirmative. Evidenced by data found on clinicaltrials.gov, this trial commenced recruiting participants on February 1st 2023 and is still actively seeking out volunteers now. The study requires 32 individuals to be recruited at one site."
Answered by AI
What is the goal of this clinical investigation?
"This four-year medical trial holds as its primary objective the evaluation of Minimal Residual Disease (MRD) rates. Secondary objectives include assessing Cardiovascular Adverse Events, analyzing Surgical Pathologic Outcomes at Radical Prostatectomy, and gauging Residual Cancer Burden (RCB) at Radical Prostatectomy."
Answered by AI
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