NCT06130995 Relugolix + Enzalutamide Study in High-Risk Prostate Cancer
| NCT ID | NCT06130995 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Oklahoma |
| Condition | Androgen Deprivation Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-12-26 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 46 participants in total. It began in 2024-12-26 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Capable of giving signed informed consent; 2. Patients must be ≥18 years of age at the time of signing the informed consent form. 3. Men with a diagnosis of adenocarcinoma of the prostate pathologically proven diagnosis with the following: • Locally advanced high-risk prostate defined as i. PSA \>20 ng/mL or ISUP grade 4/5 (Gleason score \>7) or cT2c or ii. Any PSA, any ISUP grade, cT3-4 or cN+ (locally advanced) 4. Have normal organ and bone marrow function measured at the screening visit including * Platelets ≥100 × 103/microliter (μL); * Hemoglobin ≥ 10.0 grams/dL; * Leukocytes (WBC) ≥ 3 × 103/μL; * Absolute neutrophil count ≥1.5 × 103/μL; * Serum AST and ALT ≤2.5 × upper limit of normal (ULN); * Total bilirubin ≤1.5 ×ULN (unless values are consistent with Gilbert's syndrome for which the total bilirubin must be \< 3x ULN); * Serum creatinine ≤ 1.5 × ULN; OR Measured or calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 6. The participant has, in the opinion of the investigator, a life expectancy of at least 6 months. 7. Male patients must be willing to use contraception during treatment and for 3 months after the last dose of study treatment when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential. Exclusion Criteria: 1. History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 6 months. 2. Patients who are receiving any other investigational agents. 3. Patients with distant metastatic cancer will be excluded from the study as intermittent hormonal therapy is not standard of care treatment for this population. 4. Active secondary malignancies requiring treatment 5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of study drugs 6. Participants with uncontrolled intercurrent illness. 7. Participant is unable to swallow pills. 8. Not a candidate for surgical or radiation therapy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06130995 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Androgen Deprivation Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06130995 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06130995 currently recruiting?
Yes, NCT06130995 is actively recruiting participants. Contact the research team at SCCIITOffice@ouhsc.edu for enrollment information.
Where is the NCT06130995 trial being conducted?
This trial is being conducted at Oklahoma City, United States.
Who is sponsoring the NCT06130995 clinical trial?
NCT06130995 is sponsored by University of Oklahoma. The trial plans to enroll 46 participants.