Combining relugolix and enzalutamide for high-risk prostate cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: SCCIITOffice@ouhsc.edu
• Phone: 405-271-8777

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fezolinetant to reduce hot flashes in men on androgen-deprivation therapy

  This trial will test whether taking fezolinetant once daily for 4 weeks reduces how often and how severe hot flashes are in men with prostate cancer who are on androgen-deprivation therapy.

  Recruiting Phase 2 Brigham and Women's Hospital · Boston, Massachusetts · NCT06957691

• Understanding how ADT for prostate cancer may raise blood pressure and whether nerves or kidneys are involved

  This study tests whether nervous system or kidney dysfunction contributes to high blood pressure in men receiving androgen deprivation therapy for prostate cancer.

  Recruiting Phase 4 Virginia Commonwealth University · Richmond, Virginia · NCT07848828

• Radiotherapy after prostate removal for node-positive prostate cancer

  This study tests whether adding pelvic radiotherapy to ongoing hormone therapy helps men with node-positive prostate cancer after prostate removal live longer without cancer progression.

  Recruiting at 5 sites Phase 3 Sun Yat-sen University · Dongguan, Guangdong and 12 other locations · NCT07477626

• Targeted tumor boost and shortened radiation schedules for prostate cancer

  This trial tests whether giving a higher radiation dose to the tumor inside the prostate (a focal boost) and delivering treatment in 12 instead of 20 sessions helps men with intermediate- or high-risk prostate cancer have fewer relapses and need less hormonal therapy.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Aarhus and 2 other locations · NCT07343349

• Acupuncture to ease hot flashes in men on hormone therapy for prostate cancer

  This trial will test if weekly acupuncture plus lifestyle education can help reduce hot flashes and related symptoms in men receiving androgen deprivation therapy for prostate cancer.

  Recruiting Inova Health Care Services · Fairfax, Virginia · NCT07335224

• Home-based telerehabilitation for rural men on hormone therapy for metastatic prostate cancer

  This trial tests whether a home telerehabilitation program helps men in rural areas receiving androgen deprivation therapy for metastatic prostate cancer feel and function better than home exercise without the technology.

  Recruiting University of Utah · Salt Lake City, Utah · NCT07032584

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.