RECRUITING

Relugolix + Enzalutamide Study in High-Risk Prostate Cancer

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Conditions

Androgen Deprivation TherapyLocally Advanced Prostate Cancerdose limiting toxicity (DLTs)pathologic complete response (pCR)minimal residual disease (MRD)radiation therapy (RT)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-26
Study Completion:2030-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06130995

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Capable of giving signed informed consent;
  2. 2. Patients must be ≥18 years of age at the time of signing the informed consent form.
  3. 3. Men with a diagnosis of adenocarcinoma of the prostate pathologically proven diagnosis with the following:
  4. 4. Have normal organ and bone marrow function measured at the screening visit including
  5. * Platelets ≥100 × 103/microliter (μL);
  6. * Hemoglobin ≥ 10.0 grams/dL;
  7. * Leukocytes (WBC) ≥ 3 × 103/μL;
  8. * Absolute neutrophil count ≥1.5 × 103/μL;
  9. * Serum AST and ALT ≤2.5 × upper limit of normal (ULN);
  10. * Total bilirubin ≤1.5 ×ULN (unless values are consistent with Gilbert's syndrome for which the total bilirubin must be \< 3x ULN);
  11. * Serum creatinine ≤ 1.5 × ULN; OR Measured or calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN
  12. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  13. 6. The participant has, in the opinion of the investigator, a life expectancy of at least 6 months.
  14. 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.
  1. 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. 2. Patients who are receiving any other investigational agents.
  3. 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. 4. Active secondary malignancies requiring treatment
  5. 5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of study drugs
  6. 6. Participants with uncontrolled intercurrent illness.
  7. 7. Participant is unable to swallow pills.
  8. 8. Not a candidate for surgical or radiation therapy

Contacts and Locations

Study Contact

lead onco nurse, RN
CONTACT
405-271-8777
SCCIITOffice@ouhsc.edu
Kelly Stratton, MD
CONTACT
(405) 271-6900
Kelly-Stratton@ouhsc.edu

Study Locations (Sites)

Stephenson Cancer Center at OU Health, University of Oklahoma Health Sciences Center (SCC-OUHSC)
Oklahoma City, Oklahoma, 73104
United States

Collaborators and Investigators

Sponsor: University of Oklahoma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-26
Study Completion Date2030-01

Study Record Updates

Study Start Date2024-12-26
Study Completion Date2030-01

Terms related to this study

Keywords Provided by Researchers

  • dose limiting toxicity (DLTs)
  • pathologic complete response (pCR)
  • minimal residual disease (MRD)
  • radiation therapy (RT)

Additional Relevant MeSH Terms

  • Androgen Deprivation Therapy
  • Locally Advanced Prostate Cancer