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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
Must not have
Intrapelvic lymph nodes as only site of prostate cancer recurrence
Prior radiotherapy to a lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My prostate cancer has come back only in the lymph nodes in my pelvis.
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I have had radiation therapy on a cancerous lesion.
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I have inflammatory bowel disease and am planned for radiotherapy in the abdomen or pelvis area.
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I have severe heart failure.
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My prostate cancer diagnosis was confirmed by a biopsy.
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I am currently receiving hormone therapy for my cancer.
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I have a stomach or intestine problem that affects how I absorb pills.
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I have had chemotherapy for prostate cancer or have undergone surgical removal of both testicles.
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I have severe or unpredictable chest pain.
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My cancer has returned in the prostate area after radiation treatment.
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My cancer has spread to my brain, spinal cord, or internal organs.
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I have a history of long QT syndrome.
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Radiotherapy cannot target all my cancer spread sites.
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I cannot swallow whole pills.

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

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

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446
87%
Fatigue
53%
Nausea
33%
Cough
27%
Pain
27%
Fall
27%
Dyspnea
27%
Depression
27%
Lymphocyte count decreased
27%
Platelet count decreased
27%
Anemia
20%
Chills
20%
Dizziness
20%
Chest pain
20%
Neutropenia
20%
Diarrhea
20%
Edema limbs
13%
Dysesthesia
13%
Insomnia
13%
Edema
13%
Constipation
13%
Delirium
13%
Dysgeusia
13%
Skin infection
13%
Vomiting
13%
Tinnitus
13%
Rash
13%
Myalgia
13%
Back pain
13%
Weakness (limb)
13%
Weight loss
7%
Proteinuria
7%
Bruising
7%
Hearing loss
7%
Anxiety
7%
Oral lesions
7%
Headaches
7%
Acute kidney injury
7%
Hypokalemia
7%
Lymphocytopenia
7%
Seizures
7%
Weakness (facial)
7%
Hearing impaired
7%
Neutrophil count decreased
7%
Death NOS
7%
Hypertension
7%
Headache
7%
Creatinine increased
7%
Fever
7%
Pleural effusion
7%
Gait disturbance
7%
Nasal congestion
7%
Tremor
7%
Urinary urgency
7%
Amnesia
7%
Hypernatremia
7%
Photophobia
7%
Urinary frequency
7%
Dysphagia
7%
Low white blood count
7%
Sneezing
7%
Cognitive disturbance
7%
Erythema multitforme
7%
Lung infection
7%
Allergy (seasonal)
7%
Muscle weakness
7%
Hypomagnesemia
7%
Parathesia (tingling)
7%
Febrile Neutropenia
7%
Anorexia
7%
Hypoxic respiratory failure
7%
Sleep apnea
7%
Encephalopathy
7%
Hypoxia
7%
Shingles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Chemotherapy
Stereotactic Body Radiation Therapy

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
~5410
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
238 Previous Clinical Trials
102,625 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,111,837 Total Patients Enrolled
Bridget F KoontzPrincipal InvestigatorNRG Oncology

Media Library

Relugolix (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05053152 — Phase 2
Prostate Adenocarcinoma Research Study Groups: Arm I (placebo, SABR), Arm II (relugolix, SABR)
Prostate Adenocarcinoma 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
~150 spots leftby Feb 2029
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