Status:
RECRUITING
Relugolix + Enzalutamide Study in High-Risk Prostate Cancer
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
Pfizer
Astellas Pharma Inc
Conditions:
Androgen Deprivation Therapy
Locally Advanced Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
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 i...
Detailed Description
This clinical trial aims to assess the effectiveness and safety of combining relugolix and enzalutamide as neoadjuvant and adjuvant androgen deprivation therapy (ADT) in patients diagnosed with high-r...
Eligibility Criteria
Inclusion
- Capable of giving signed informed consent;
- Patients must be ≥18 years of age at the time of signing the informed consent form.
- 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)
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- The participant has, in the opinion of the investigator, a life expectancy of at least 6 months.
- 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
- History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 6 months.
- Patients who are receiving any other investigational agents.
- Patients with distant metastatic cancer will be excluded from the study as intermittent hormonal therapy is not standard of care treatment for this population.
- Active secondary malignancies requiring treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of study drugs
- Participants with uncontrolled intercurrent illness.
- Participant is unable to swallow pills.
- Not a candidate for surgical or radiation therapy
Key Trial Info
Start Date :
December 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06130995
Start Date
December 26 2024
End Date
January 1 2030
Last Update
February 11 2025
Active Locations (1)
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1
Stephenson Cancer Center at OU Health, University of Oklahoma Health Sciences Center (SCC-OUHSC)
Oklahoma City, Oklahoma, United States, 73104