RecruitingPhase 1NCT06130995

Relugolix + Enzalutamide Study in High-Risk Prostate Cancer

Phase IB Trial of Relugolix and Enzalutamide as Neoadjuvant/ Adjuvant to Local-regional Treatment in Patients With High-risk Locally Advanced Prostate CAncer (RENAPCA)


Sponsor

University of Oklahoma

Enrollment

46 participants

Start Date

Dec 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test how effective and safe it is to use a combination of two medications, relugolix and enzalutamide, in patients with advanced prostate cancer. We want to see if this combination can help improve the chances of curing the cancer and make the patients live longer without the cancer getting worse. The main questions we want to answer in this study are: * Can using relugolix and enzalutamide together help increase the chances of curing high-risk advanced prostate cancer? * Does this combination treatment help patients live longer without their cancer getting worse? Participants in this study will be asked to take relugolix and enzalutamide as part of their cancer treatment. They will also undergo Radiation Therapy or prostatectomy, which are standard treatments for this type of cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether combining two hormone-blocking drugs — relugolix (a hormone-reducing pill) and enzalutamide (a testosterone-blocking drug) — can improve outcomes for men with high-risk, locally advanced prostate cancer. Both drugs work to lower or block the male hormones (androgens) that fuel prostate cancer growth. **You may be eligible if...** - You are 18 or older and have been diagnosed with high-risk or locally advanced prostate cancer - Your PSA is greater than 20, or your Gleason score is 8-10, or cancer has spread to nearby lymph nodes or tissue (but not distant organs) - You are a candidate for surgery or radiation therapy - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - You have prostate cancer that has spread to distant organs (metastatic disease) - You had a heart attack, heart failure, or stroke within the past 6 months - You are unable to swallow pills - You are on other investigational drugs - You have another active cancer requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRelugolix and Enzalutamide

Dose level of Relugolix and Enzalutamide Safety Lead-in Cohort, 3-12 patient. Relugolix;120 mg, oral, once daily, with a loading dose of 360 mg on day 1, Enzalutamide; 120-160 mg, oral, once daily. Dose Expansion Cohort, up to 34 patients. Relugolix;120 mg, oral, once daily, with a loading dose of 360 mg on day 1, Enzalutamide; To be determined by safety lead-in cohort. One cycle = 3 months The dose limiting toxicity (DLT) period is the first 28 days Neoadjuvant ADT: 6 months; Relugolix: 120 mg orally, daily (with a 360 mg loading dose on day 1, Enzalutamide: 160 mg (or 120 mg) orally, daily Concurrent ADT during Radiation Therapy; Relugolix: 120 mg orally, daily (with a 360 mg loading dose on day 1, Enzalutamide: 160 mg (or 120 mg) orally, daily Maintenance ADT: Additional 18 months; Relugolix: 120 mg orally, daily (with a 360 mg loading dose on day 1, Enzalutamide: 160 mg (or 120 mg) orally, daily


Locations(1)

Stephenson Cancer Center at OU Health, University of Oklahoma Health Sciences Center (SCC-OUHSC)

Oklahoma City, Oklahoma, United States

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NCT06130995


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