Combining relugolix and enzalutamide for high-risk prostate cancer treatment

Phase IB Trial of Relugolix and Enzalutamide as Neoadjuvant/ Adjuvant to Local-regional Treatment in Patients With High-risk Locally Advanced Prostate CAncer (RENAPCA)

This study is testing if combining two medications, relugolix and enzalutamide, can help men with high-risk prostate cancer do better with their treatment and live longer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University of Oklahoma (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Oklahoma City, Oklahoma)
• Trial ID: NCT06130995 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of using relugolix and enzalutamide together as neoadjuvant and adjuvant androgen deprivation therapy in men with high-risk locally advanced prostate cancer. Participants will receive this combination treatment alongside standard therapies such as radiation or surgery. The study aims to determine if this approach can improve the chances of curing the cancer and prolong survival without disease progression. A total of up to 41 patients will be enrolled, with a focus on monitoring efficacy, safety, and biomarker changes throughout the treatment process.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older with a diagnosis of high-risk locally advanced prostate cancer.

Not a fit: Patients with low-risk prostate cancer or those who are not candidates for radiation therapy or surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve cure rates and survival for patients with high-risk prostate cancer.

How similar studies have performed: Other studies have shown promise with similar combination therapies in prostate cancer, indicating potential for success in this approach.

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

Where this trial is running

Oklahoma City, Oklahoma

• Stephenson Cancer Center at OU Health, University of Oklahoma Health Sciences Center (SCC-OUHSC) — Oklahoma City, Oklahoma, United States (Recruiting)

Study contacts

• Study coordinator: lead onco nurse, RN

Conditions Androgen Deprivation Therapy; Locally Advanced Prostate Cancer; dose limiting toxicity; pathologic complete response; minimal residual disease; radiation therapy