Relugolix + Enzalutamide Study in High-Risk Prostate 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.

Conditions

Androgen Deprivation Therapy, Locally Advanced Prostate Cancer

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Study Overview

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Study Details

Study overview

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.

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

Relugolix + Enzalutamide Study in High-Risk Prostate Cancer

Condition
Androgen Deprivation Therapy
Intervention / Treatment

-

Contacts and Locations

Oklahoma City

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Oklahoma,

Study Record Dates

2030-01