Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study

Conditions

• Oligometastatic Prostate Carcinoma
• Prostate Adenocarcinoma
• Prostate Ductal Adenocarcinoma
• Prostate Intraductal Carcinoma
• Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo urine and blood sample collection
• Bone Scan — PROCEDURE
  Undergo bone scan
• Computed Tomography — PROCEDURE
  Undergo CT and/or PET/CT
• Fluciclovine F18 — OTHER
  Given fluciclovine F18
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI and/or PET/MRI
• Placebo Administration — DRUG
  Given PO
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT and/or PET/MRI
• PSMA PET Scan — PROCEDURE
  Undergo PSMA PET/CT or PET/MRI
• Relugolix — DRUG
  Given PO
• Stereotactic Body Radiation Therapy — RADIATION
  Undergo SABR

Study Details

This phase II trial compares the usual treatment of radiation therapy alone to using the study drug, relugolix, plus the usual radiation therapy in patients with castration-sensitive prostate cancer that has spread to limited other parts of the body (oligometastatic). Relugolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of testosterone (a male hormone) produced by the body. It may stop the growth of cancer cells that need testosterone to grow. Radiation therapy uses high-energy x rays or protons to kill tumor cells. The addition of relugolix to the radiation may reduce the chance of oligometastatic prostate cancer spreading further.

Key Dates

Start date

Apr 20, 2022

Status verified

Apr 2026

Primary completion

Feb 1, 2029

Completion

Feb 1, 2029

Study Design

Enrollment

194 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Arm I (placebo, SABR)
  Patients receive placebo PO QD on days 1-180 and undergo SABR for 1-3 weeks in the absence of disease progression or unacceptable toxicity. Patients may also undergo bone scan, CT, MRI, PSMA PET/CT or PET/MRI, and/or fluciclovine F18 PET/CT or PET/MRI at time of disease progression. Patients may optionally undergo urine and blood sample collection throughout the trial.
• Experimental: Arm II (relugolix, SABR)
  Patients receive relugolix PO QD on days 1-180 and undergo SABR for 1-3 weeks in the absence of disease progression or unacceptable toxicity. Patients may also undergo bone scan, CT, MRI, PSMA PET/CT or PET/MRI, and/or fluciclovine F18 PET/CT or PET/MRI at time of disease progression. Patients may optionally undergo urine and blood sample collection throughout the trial.

Primary Outcome Measure

Radiological progression-free survival (rPFS) [ Time Frame: Time from randomization to the occurrence of radiological progression detected by conventional imaging or death from any cause, assessed up to 5 years ]

Locations (242)

Find similar trials in Phoenix, AZ

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