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Hormone Therapy
Relugolix + Enzalutamide for Prostate Cancer
Phase 1
Waitlist Available
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men with a diagnosis of adenocarcinoma of the prostate meeting specific criteria
Patients must be ≥18 years of age at the time of signing the informed consent form
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-6 years
Awards & highlights
Summary
This trial tests if combining two meds can help treat advanced prostate cancer & improve chances of curing it & help patients live longer.
Who is the study for?
This trial is for men over 18 with advanced prostate cancer who can consent to treatment, have a life expectancy of at least 6 months, and normal organ function. They must be able to perform daily activities (ECOG status 0-2) and agree to use contraception during the study.
What is being tested?
The study tests the effectiveness and safety of combining relugolix with enzalutamide in treating high-risk advanced prostate cancer. It aims to see if this combo increases cure rates and extends the time patients live without their cancer worsening.
What are the potential side effects?
Potential side effects from relugolix may include hot flashes, fatigue, diarrhea, constipation, or joint pain. Enzalutamide could cause weakness or dizziness, back pain, reduced appetite, blood pressure changes or seizures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man diagnosed with a specific type of prostate cancer.
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I am 18 years old or older.
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My blood, liver, and kidney tests are normal.
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I am able to get out of my bed or chair and move around.
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I agree to use contraception during and for 3 months after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-6 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of patient experiencing dose limiting toxicity (DLT) and tolerable dose of relugolix and enzalutamide combination
Proportion of patients experiencing Pathologic Complete Response (pCR) and Minimal Residual Disease (MRD) in Neoadjuvant ADT with the combination of Relugolix and Enzalutamide
Secondary study objectives
Diagnostic precision and constraints of biopsy in assessing positive margin rates and rates of pathologic downgrade.
Frequency and severity of adverse events of relugolix and enzalutamide
Objective response rate (ORR) of neoadjuvant ADT of relugolix and enzalutamide
+2 moreSide effects data
From 2020 Phase 3 trial • 388 Patients • NCT0304973511%
Hot flush
11%
Headache
5%
Hypertension
3%
Arthralgia
1%
Upper respiratory tract infection
1%
Avulsion fracture
1%
Ankle fracture
1%
Uterine myoma expulsion
1%
Haematemesis
1%
uterine leiomyoma
1%
Menorrhagia
1%
Pelvic pain
1%
Rhabdomyolysis
1%
Cough
1%
Vitreous detachment
1%
Hypothyroidism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Relugolix Plus E2/NETA (Group A)
Relugolix Plus Delayed E2/NETA (Group B)
Placebo (Group C)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Prostate Cancer Combo Therapy TrialExperimental Treatment1 Intervention
A single-arm Phase Ib study explores the effectiveness and safety of neoadjuvant and adjuvant hormonal therapy combining relugolix and enzalutamide in high-risk locally advanced prostate cancer patients eligible for ADT followed by radiation therapy or surgery.
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Who is running the clinical trial?
University of OklahomaLead Sponsor
465 Previous Clinical Trials
91,142 Total Patients Enrolled
2 Trials studying Prostate Cancer
110 Patients Enrolled for Prostate Cancer
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