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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

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

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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.

NRG PROMETHEAN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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%

Dyspnea

64%

Nausea

57%

Fatigue

43%

Constipation

36%

Pain

36%

Dizziness

29%

Anemia

29%

Back pain

29%

Vomiting

21%

Anorexia

21%

Chest pain

21%

Lymphocyte count decreased

21%

Death NOS

21%

Anxiety

21%

Fall

14%

Wheezing

14%

Dysphagia

14%

Hypotension

14%

Depression

14%

Diarrhea

14%

Platelet count decreased

14%

Abdominal Pain

14%

Edema

14%

Fever

14%

Headache

14%

Insomnia

14%

Palpitations

Alopecia

Dehydration

Blurred vision

Sinusitis

Otitis externa

Dysgeusia

Hemorrhoids

Amnesia

Confusion

Hypertension

Creatinine increased

Dementia

Productive cough

Pneumonitis

Dysuria

White blood cell count decreased

Throat pain

Bone marrow biopsy

Hearing impaired

Rash

Hypernatremia

Eye pain

Tachycardia

Lung infection

Neuropathy

Pleuritic pain

Neutropenia

Hypoxia

Aspiration pneumonia

Blood bilirubin increased

Muscle weakness

Tremor

Weight loss

Thrombocytopenia

Floaters

Toothache

Esophagitis

Leukocytosis

Edema limbs

Gait disturbance

Parathesia (tingling)

Edema face

COPD

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor

231 Previous Clinical Trials

100,592 Total Patients Enrolled

20 Trials studying Prostate Cancer

12,301 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,407 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,173 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have enrolled in this clinical experiment?

"Affirmative. According to the information located on clinicaltrials.gov, this trial is in active recruitment mode since its inception on December 8th 2021. As of November 22nd 2022, 269 patients are needed from 85 distinct divisions for participation in this research project."

Answered by AI

Could you assess the safety of Stereotactic Body Radiation Therapy for human subjects?

"Stereotactic Body Radiation Therapy has been assigned a rating of 2 based on the fact that there is only some supporting data regarding its safety and no evidence for its efficacy."

Answered by AI

Are there numerous locales across North America that are facilitating this clinical trial?

"85 clinical trial sites are accepting patients, including Geisinger Wyoming Valley/Henry Cancer Center in Wilkes-Barre, Geisinger Cancer Services-Pottsville in Pottsville, and UH Seidman Cancer Center at Lake Health Mentor Campus in Mentor."

Answered by AI

Is this experiment an unprecedented endeavor?

"As of now, there are seven ongoing trials for Stereotactic Body Radiation Therapy in 364 cities and 20 countries. This form of treatment first entered clinical testing back in 2018 with Myovant Sciences GmbH sponsoring the Phase 3 study that included 803 participants. Since then, a further 170 experiments have been conducted to support its efficacy."

Answered by AI

What other research has been conducted regarding Stereotactic Body Radiation Therapy?

"Currently, seven Stereotactic Body Radiation Therapy (SBRT) studies are underway with three in Phase 3. Although the trials based out of Fort Collins, Colorado are the most prominent ones, 610 trial sites across the globe are conducting SBRT research."

Answered by AI

Is recruitment still available for this research endeavor?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial is actively enrolling participants, with an initial posting date of December 8th 2021 and latest edit on November 22nd 2022. 269 candidates from 85 sites are needed for the study's completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer

2021. "Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05053152.

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