Relugolix + Enzalutamide Study in High-Risk Prostate Cancer

Launched by UNIVERSITY OF OKLAHOMA · Nov 8, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness and safety of combining two medications, relugolix and enzalutamide, for men with high-risk, locally advanced prostate cancer. The main aim is to find out if this combination can help improve the chances of curing the cancer and allow patients to live longer without their cancer worsening. Participants will receive these medications as part of their cancer treatment, alongside standard therapies such as radiation or surgery.

To be eligible for the trial, participants must be adult men aged 18 or older with a confirmed diagnosis of high-risk prostate cancer. They should have normal organ function and be able to give their consent to participate. Those with certain health conditions or who are using other investigational drugs will not be able to join. If you decide to participate, you will be closely monitored throughout the study to assess how well the treatment works and how it affects your health. It's important to discuss this option with your healthcare provider to see if it might be the right choice for you.

Gender

MALE

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