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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
No Placebo-Only Group

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Minimal Residual Disease (MRD) rate
Inverse PCR
Secondary study objectives
Assess Cardiovascular Adverse Events
Assess adverse events
Evaluate changes in Prostate specific antigen (PSA)
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2190
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
4,427 Previous Clinical Trials
289,164,579 Total Patients Enrolled
University of California, San DiegoOTHER
1,189 Previous Clinical Trials
1,587,709 Total Patients Enrolled
Rana R. McKay, MDPrincipal InvestigatorUniversity of California, San Diego
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

LHRH agonist (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05498272 — Phase 2
BRCA1 Research Study Groups: Investigational Group
BRCA1 Clinical Trial 2023: LHRH agonist Highlights & Side Effects. Trial Name: NCT05498272 — Phase 2
LHRH agonist (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05498272 — Phase 2
~10 spots leftby Dec 2025