← Back to Search

Hormone Therapy

Relugolix + Radiation for Advanced-Stage Prostate Cancer (NRG PROMETHEAN Trial)

Phase 2
Recruiting
Led By Bridget F Koontz
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HCV infection treated and cured or undetectable viral load if currently on treatment
HBV viral load undetectable on suppressive therapy if indicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

NRG PROMETHEAN Trial Summary

This trial is testing whether a drug that lowers testosterone levels combined with radiation therapy can shrink tumors in patients with prostate cancer that has spread to 1 to 5 other parts of the body.

Who is the study for?
Men aged 18+ with advanced-stage prostate cancer that has spread to a limited number of other body parts (1-5 sites). They must have had prior treatment for prostate cancer, no severe comorbidities preventing protocol completion, and agree to use effective contraception. Excluded are those with only intrapelvic lymph node recurrence or certain heart conditions.Check my eligibility
What is being tested?
The trial is testing if adding Relugolix to usual radiation therapy can shrink tumors in men with oligometastatic prostate cancer. Relugolix lowers testosterone which may inhibit tumor growth. Participants will either receive Relugolix or a placebo alongside their radiation treatments.See study design
What are the potential side effects?
Potential side effects of Relugolix include hot flashes, fatigue, diarrhea, constipation, joint pain and high blood pressure. It might also affect liver enzymes and cause reactions at the injection site.

NRG PROMETHEAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My hepatitis C is cured or undetectable while on treatment.
Select...
My hepatitis B virus load is undetectable with current treatment.
Select...
I have 1 to 5 small cancer spread areas in bones or soft tissues, confirmed by a PET scan within the last 4 months.
Select...
I have been diagnosed with prostate cancer.
Select...
I have undergone treatment aimed at curing prostate cancer.
Select...
I am 18 years old or older.

NRG PROMETHEAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Radiological progression-free survival (rPFS)
Secondary outcome measures
Fatigue
Metastasis-free Survival
Overall Survival
+2 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446
79%
Cough
64%
Nausea
64%
Dyspnea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Back pain
29%
Anemia
29%
Vomiting
21%
Chest pain
21%
Anorexia
21%
Lymphocyte count decreased
21%
Death NOS
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Dysphagia
14%
Depression
14%
Hypotension
14%
Diarrhea
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Creatinine increased
7%
Alopecia
7%
Sinusitis
7%
Dysgeusia
7%
Hemorrhoids
7%
Dementia
7%
Productive cough
7%
Dysuria
7%
Throat pain
7%
Hearing impaired
7%
Rash
7%
Bone marrow biopsy
7%
Hypernatremia
7%
Eye pain
7%
Tachycardia
7%
Lung infection
7%
Amnesia
7%
Neuropathy
7%
Dehydration
7%
Pneumonitis
7%
Pleuritic pain
7%
Otitis externa
7%
White blood cell count decreased
7%
Confusion
7%
Neutropenia
7%
Hypertension
7%
Blurred vision
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Esophagitis
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy

NRG PROMETHEAN Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm II (relugolix, SABR)Experimental Treatment3 Interventions
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.
Group II: Arm I (placebo, SABR)Placebo Group3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Relugolix
2016
Completed Phase 3
~5360
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
232 Previous Clinical Trials
100,518 Total Patients Enrolled
20 Trials studying Prostate Cancer
12,301 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,729 Previous Clinical Trials
40,965,787 Total Patients Enrolled
566 Trials studying Prostate Cancer
529,208 Patients Enrolled for Prostate Cancer
Bridget F KoontzPrincipal InvestigatorNRG Oncology

Media Library

Relugolix (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05053152 — Phase 2
Prostate Cancer Research Study Groups: Arm I (placebo, SABR), Arm II (relugolix, SABR)
Prostate Cancer Clinical Trial 2023: Relugolix Highlights & Side Effects. Trial Name: NCT05053152 — Phase 2
Relugolix (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05053152 — Phase 2
~31 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top