Actively Recruiting
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Led by Northwestern University · Updated on 2025-10-21
50
Participants Needed
1
Research Sites
428 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well relugolix and enzalutamide, in combination with radiation therapy, works in treating patients with very high risk prostate cancer. Relugolix is a form of androgen deprivation therapy. It prevents the release of testosterone, a hormone required to sustain prostate growth. Reducing testosterone levels may inhibit the proliferation of prostate tumor cells that need testosterone to grow. Enzalutamide is an androgen receptor signaling inhibitor. It inhibits the activity of prostate tumor cell receptors, which may reduce proliferation of prostate tumor cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Adding relugolix and enzalutamide to radiation therapy may be more effective at treating patients with very high risk prostate cancer than giving any of these treatments alone.
CONDITIONS
Official Title
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed prostate adenocarcinoma meeting NCCN very-high-risk criteria including at least one: cT3b-cT4 stage, more than 4 cores with grade group 4 or 5, primary Gleason pattern 5, or 2-3 NCCN high-risk features
- Involved pelvic lymph nodes below the common iliac bifurcation allowed if very-high-risk criteria met
- Age 18 years or older
- Testosterone level greater than 50 ng/dL within 90 days before registration
- Prior androgen deprivation therapy allowed if less than 60 days total and testosterone is above 50 ng/dL before enrollment; must stop 5-alpha reductase inhibitors before treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- White blood cells count at least 2,500/mcL
- Absolute neutrophil count at least 1,500/mcL
- Hemoglobin level at least 8 g/dL
- Platelet count at least 80,000/mcL
- Liver enzymes AST and ALT less than or equal to 3 times the institutional upper limit of normal
- Creatinine level within institutional normal limits
- Glomerular filtration rate (GFR) at least 30 mL/min/1.73 m2
- For patients with HIV, on effective anti-retroviral therapy with undetectable viral load for 3 months and CD4 count at least 200 cells/µL
- Cardiac function better than New York Heart Association Functional Classification class III
- Able to undergo magnetic resonance imaging and tolerate PET/CT imaging and radiation therapy
- Male patients with female partners of reproductive potential agree to use effective contraception during treatment and for 3 months after; male patients must use condoms during sex with pregnant women
- Ability to understand and willing to sign informed consent and comply with study requirements
You will not qualify if you...
- Evidence of metastatic disease by clinical or radiologic assessment
- Prior invasive cancer except certain skin cancers, carcinoma in situ of male breast, penis, oral cavity, or stage Ta bladder cancer unless disease-free for at least 2 years
- Prior radiotherapy that overlaps with planned radiation fields
- History of inflammatory bowel disease
- Symptomatic congestive heart failure New York Heart Association Class III or IV within 4 months prior to registration
- Unstable angina requiring hospitalization within 4 months prior to registration
- History of seizure disorder or condition with high seizure risk
- Psychiatric illness or social situations limiting study compliance
- History of repeated falls or fractures in past 12 months risking poor bone outcomes from therapy
- Any illness or condition compromising study compliance or patient safety
- Inability to take oral medication or having malabsorption or uncontrolled gastrointestinal conditions that may affect drug absorption (e.g., nausea, diarrhea, vomiting)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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