Testing the Addition of Relugolix to Radiation Therapy for Advanced Prostate Cancer

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05053152

Provider View

This phase II clinical trial is exploring whether adding the drug relugolix to radiation therapy can help shrink tumors in patients with prostate cancer that has spread to a few other parts of the body. Relugolix works by lowering testosterone levels, which may help stop the growth of cancer cells that need testosterone to grow.

Patient Parameters

Program Overview

The purpose of this study is to see if combining relugolix with radiation therapy can effectively reduce tumors in patients with prostate cancer that has spread to 1 to 5 other areas (oligometastatic). Testosterone can promote the growth of prostate cancer cells, and relugolix helps lower testosterone levels in the body. This combination may help prevent the cancer from growing or spreading further.

Description

PRIMARY OBJECTIVE:

  • To compare how long patients live without their cancer getting worse when treated with radiation therapy and either a placebo or relugolix.

SECONDARY OBJECTIVES:

  • To compare how long patients live without their cancer getting worse using different types of scans.
  • To compare patients' sexual and hormonal quality of life between the two treatment groups.
  • To compare other quality of life measures using specific questionnaires.
  • To compare the time until additional treatment is needed and the time until the cancer becomes resistant to treatment.
  • To compare local cancer progression, new metastases, cancer-specific death, and overall survival between the two groups.
  • To determine and compare side effects between the two treatment groups.

EXPLORATORY OBJECTIVE:

  • To study genetic and blood markers that might predict treatment response.

OUTLINE: Patients are randomly assigned to one of two groups.

GROUP I: Patients take a placebo pill daily for 180 days and receive radiation therapy for 1-3 weeks, unless the cancer progresses or side effects are unacceptable.

GROUP II: Patients take relugolix daily for 180 days and receive radiation therapy for 1-3 weeks, unless the cancer progresses or side effects are unacceptable.

After treatment, patients are followed up at 3 and 6 months, every 6 months for 4 years, and then annually.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer confirmed by lab tests.
  • Age 18 or older.
  • Good overall health with a performance status score of 0 to 2.
  • Previously received treatment aimed at curing the prostate cancer.
  • Must meet specific diagnostic criteria based on recent medical tests.
  • Have 1 to 5 small areas of cancer spread detected by specific scans.
  • PSA level of 10.0 ng/mL or lower, meeting certain conditions.
  • At least 3 PSA tests in the last two years.
  • Testosterone level of 100 ng/dL or higher.
  • Normal liver function tests.
  • No active hepatitis B or C infections.
  • HIV-positive patients must have an undetectable viral load.
  • Must agree to use effective contraception during the study.
  • Must provide informed consent to participate.

Exclusion Criteria

  • Evidence of local tumor recurrence in the prostate or surrounding areas after previous treatment.
  • Currently on hormone therapy for prostate cancer.
  • Clear evidence of cancer spread on conventional imaging.
  • Cancer spread to the spinal cord, brain, or internal organs.
  • Certain rare types of prostate cancer.
  • History of other cancers unless disease-free for 3 years.
  • Previous chemotherapy for prostate cancer.
  • Previous radiation to the same area being studied.
  • Inability to treat all cancer sites with radiation.
  • Only cancer recurrence in pelvic lymph nodes.
  • Difficulty swallowing pills.
  • Gastrointestinal disorders affecting medication absorption.
  • Certain heart conditions or other serious health issues.

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