AzTrials
AzTrials

Oligometastatic Prostate CarcinomaPhase 2NCT05053152

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

A Phase 2 study testing Biospecimen Collection, Bone Scan and Computed Tomography in people with Oligometastatic Prostate Carcinoma and Prostate Adenocarcinoma, run by NRG Oncology at 245 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Biospecimen Collection, Bone Scan and Computed Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
194 participants
Where
245 sitesin 2 countries
Study dates
20 Apr 2022to 1 Feb 2034
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically (histologically or cytologically) proven diagnosis of prostate adenocarcinoma at any anatomical location (for example, prostate, metastatic site), including intraductal or ductal carcinoma, at any time before registration
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 180 days prior to registration
  • Prior curative-intent treatment to the prostate, by either:
  • External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites
  • Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes.
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  • Note: Patients who have received curative intent with radiation prior to prostatectomy are eligible and should be categorized as RT to Intact Prostate since that was the first curative intent
  • Must meet study entry criteria based on the following diagnostic workup within 120 days prior to registration:
  • History and physical examination;
  • Fluciclovine or PSMA PET scan;
  • PET must be combined with either CT or MRI, but a diagnostic CT or MRI reading/interpretation is not required
  • 1 - 5 oligometastatic lesions in bone and/or nodal/soft tissue (non-abutting nodes are counted separately) sites on fluciclovine or PSMA PET within 180 days prior to registration and includes at least ONE of the following:
  • Bone - each metastasis is counted (for example, 2 distinct lesions in the right ilium count as 2 oligometastatic lesions)
  • Extrapelvic Nodal/ soft tissue - requires at least one extrapelvic inguinal or a nodal/soft tissue lesion superior to the iliac bifurcation (that is, American Joint Committee on Cancer [AJCC] M1a version 8)
  • Note: Although a patient must have bone and/or extrapelvic disease to be eligible, when counting the number of oligometastatic lesions, each lymph node lesion, whether pelvic or extrapelvic, is counted (for example, 2 distinct lymph nodes in the right external iliac basin count as 2 oligometastatic lesions; one extrapelvic and one pelvic node count as 2 oligometastic lesions, etc)
  • Serum total prostate-specific antigen (PSA) =< 10.0 ng/mL that also meets ONE of the following PSA recurrence definitions:
  • If patient has received-radiation therapy to intact prostate, either
  • PSA > post-RT nadir PSA + 2 ng/mL obtained within 180 days prior to registration, or
  • PSA > 0.2 ng/mL with at least two rises from post-treatment nadir with the most recent PSA within 180 days prior to registration
  • If patient has received a radical prostatectomy with or without post-op RT, either
  • Current PSA > 0.2 ng/mL, with a second confirmatory PSA > 0.2 ng/mL, with most recent PSA obtained within 180 days prior to registration, or
  • Two consecutive PSA rises from post-operative nadir, with most recent PSA obtained within 180 days prior to registration
  • Must have >= 3 PSA values within the last two years since end of primary treatment or within the last 2 years prior to registration, whichever is less
  • Note: PSA doubling time must be calculated by entering all PSA values since end of primary treatment or within the last 2 years prior to registration (whichever is less) into the PSA Doubling Time Calculator found at MDCalc.com
  • Serum total testosterone >= 100 ng/dL within 180 days prior to registration
  • Note: Prior androgen deprivation therapy (other than bilateral orchiectomy) is allowed if discontinued prior to registration and serum total testosterone is >= 100 ng/dL
  • Total bilirubin: =< 1.5 x institutional upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, subject is eligible if direct bilirubin is =< 1.5 x ULN) (within 180 days prior to registration)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]): =< 2.5 x institutional ULN (within 180 days prior to registration)
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • The patient must agree to use a highly effective contraception (even men with vasectomies) if he is having sex with a woman of childbearing potential or with a woman who is pregnant while on study drug and for 2 weeks following the last dose of study drug
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

Who cannot join

  • Currently on androgen deprivation or anti-androgen therapy
  • Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, etc.) metastasis
  • Note: Spinal metastases (PET-detected) with epidural extension are eligible if there is > 0.3 cm spatial separation between the gross tumor volume and spinal cord. Lung metastases are eligible
  • Biopsy-proven prostatic carcinoma with signet-ring, sarcomatoid, or neuroendocrine features (for example, small cell)
  • Prior metastatic or non-metastatic, invasive malignancy (except non metastatic, non-melanomatous skin cancer) unless continuously disease free for >= 3 years
  • Prior chemotherapy for prostate cancer or bilateral orchiectomy
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  • Note: Prior chemotherapy for a different cancer is allowed if continuously disease-free for >= 3 years
  • Prior high dose radiotherapy to a lesion (i.e. oligometastatic recurrence by PET)
  • Note: Lesions included in or near a previously irradiated planning target volume (PTV) are eligible as long as previous delivered dose is estimated to be less than an EQD2 of 50 Gy
  • Inability to treat all oligometastatic sites with radiotherapy in the judgement of the investigator
  • Intrapelvic lymph nodes as only site of prostate cancer recurrence
  • Inability to swallow whole, undivided, unchewed, and uncrushed pills
  • Known gastrointestinal disorder affecting oral medication absorption
  • Co-morbidity defined as follows:
  • Patients with any comorbidities that would prohibit completion of protocol specified therapy
  • Inflammatory bowel disease in patients in whom abdominopelvic radiotherapy is planned
  • History of congenital long QT syndrome
  • Current severe or unstable angina
  • New York Heart Association functional classification III/IV heart failure (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification)

Trial locations and contacts

245 sites in 2 countries.

245 sites in 2 countries

United States242 sites

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Saint Luke's Cancer Center - Allentown

    Allentown, Pennsylvania, 18104

  • AdventHealth Altamonte

    Altamonte Springs, Florida, 32701

  • Alton Memorial Hospital

    Alton, Illinois, 62002

  • UPMC Altoona

    Altoona, Pennsylvania, 16601

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • UH Seidman Cancer Center at UH Avon Health Center

    Avon, Ohio, 44011

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Carlisle Regional Cancer Center

    Carlisle, Pennsylvania, 17015

  • AdventHealth Celebration

    Celebration, Florida, 34747

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • Chambersburg Hospital

    Chambersburg, Pennsylvania, 17201

  • Ralph H Johnson VA Medical Center

    Charleston, South Carolina, 29401

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Michigan Healthcare Professionals Clarkston

    Clarkston, Michigan, 48346

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Emory Decatur Hospital

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • AdventHealth Porter

    Denver, Colorado, 80210

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

  • Fox Chase Cancer Center - East Norriton Hospital Outpatient Center

    East Norriton, Pennsylvania, 19401

  • Saint Luke's Hospital-Anderson Campus

    Easton, Pennsylvania, 18045

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Shaw Cancer Center

    Edwards, Colorado, 81632

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Michigan Healthcare Professionals Farmington

    Farmington Hills, Michigan, 48334

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 30214

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528

  • Parkview Regional Medical Center

    Fort Wayne, Indiana, 46845

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Fox Chase Cancer Center Buckingham

    Furlong, Pennsylvania, 18925

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Mary Bird Perkins Cancer Center - Gonzales

    Gonzales, Louisiana, 70737

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Banner North Colorado Medical Center

    Greeley, Colorado, 80631

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Marin General Hospital

    Greenbrae, California, 94904

  • East Carolina University

    Greenville, North Carolina, 27834

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • UCHealth Highlands Ranch Hospital

    Highlands Ranch, Colorado, 80129

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

  • IRMC Cancer Center

    Indiana, Pennsylvania, 15701

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

  • Emory Johns Creek Hospital

    Johns Creek, Georgia, 30097

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • FHCC at EvergreenHealth

    Kirkland, Washington, 98034

  • GenesisCare USA - Lakewood Ranch

    Lakewood Rch, Florida, 34202

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • Sechler Family Cancer Center

    Lebanon, Pennsylvania, 17042

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • AMG Libertyville - Oncology

    Libertyville, Illinois, 60048

  • AdventHealth Littleton

    Littleton, Colorado, 80122

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • UofL Health Medical Center Northeast

    Louisville, Kentucky, 40245

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • Banner North Colorado Medical Center - Loveland Campus

    Loveland, Colorado, 80539

  • Covenant Medical Center-Lakeside

    Lubbock, Texas, 79410

  • Michigan Healthcare Professionals Macomb

    Macomb, Michigan, 48044

  • Michigan Healthcare Professionals Madison Heights

    Madison Heights, Michigan, 48071

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

    Mechanicsburg, Pennsylvania, 17050

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • Mary Bird Perkins Cancer Center - Metairie

    Metairie, Louisiana, 70002

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006

  • LSU Healthcare Network / Metairie Multi-Specialty Clinic

    Metairie, Louisiana, 70006

  • Bon Secours Saint Francis Medical Center

    Midlothian, Virginia, 23114

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

  • Memorial Medical Center

    Modesto, California, 95355

  • UPMC Hillman Cancer Center in Coraopolis

    Moon Township, Pennsylvania, 15108

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

  • Carolina Regional Cancer Center

    Myrtle Beach, South Carolina, 29577

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269

  • Drexel Town Square Health Center

    Oak Creek, Wisconsin, 53154

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • The Valley Hospital - Luckow Pavilion

    Paramus, New Jersey, 07652

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • AdventHealth Parker

    Parker, Colorado, 80138

  • University Hospitals Parma Medical Center

    Parma, Ohio, 44129

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Cancer Center at Saint Joseph's

    Phoenix, Arizona, 85004

  • UPMC-Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • UPMC-Saint Margaret

    Pittsburgh, Pennsylvania, 15215

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

  • GenesisCare USA - Plantation

    Plantation, Florida, 33324

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Geisinger Cancer Services-Pottsville

    Pottsville, Pennsylvania, 17901

  • Saint Luke's Hospital - Upper Bucks Campus

    Quakertown, Pennsylvania, 18951

  • University Hospitals Portage Medical Center

    Ravenna, Ohio, 44266

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Aspirus Cancer Care - James Beck Cancer Center

    Rhinelander, Wisconsin, 54501

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • Bon Secours Cancer Institute at Reynolds Crossing

    Richmond, Virginia, 23230

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

  • Highland Hospital

    Rochester, New York, 14620

  • University of Rochester

    Rochester, New York, 14642

  • Phelps Health Delbert Day Cancer Institute

    Rolla, Missouri, 65401

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073

  • Moffitt Cancer Center at SouthShore

    Ruskin, Florida, 33570

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • Dartmouth Cancer Center - North

    Saint Johnsbury, Vermont, 05819

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • FHCC at Northwest Hospital

    Seattle, Washington, 98133

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

  • UPMC Cancer Center at UPMC Northwest

    Seneca, Pennsylvania, 16346

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • Memorial Hospital East

    Shiloh, Illinois, 62269

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • VCU Community Memorial Health Center

    South Hill, Virginia, 23970

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136

  • Aspirus Cancer Care - Stevens Point

    Stevens Point, Wisconsin, 54481

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

  • Cleveland Clinic Cancer Center Strongsville

    Strongsville, Ohio, 44136

  • Saint Luke's Hospital - Monroe Campus

    Stroudsburg, Pennsylvania, 18360

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

  • Moffitt Cancer Center-International Plaza

    Tampa, Florida, 33607

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida, 33612

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Corewell Health Beaumont Troy Hospital

    Troy, Michigan, 48085

  • Michigan Healthcare Professionals Troy

    Troy, Michigan, 48098

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Sutter Solano Medical Center/Cancer Center

    Vallejo, California, 94589

  • UPMC Washington Hospital Radiation Oncology

    Washington, Pennsylvania, 15301

  • George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188

  • Aspirus Regional Cancer Center

    Wausau, Wisconsin, 54401

  • Aurora Cancer Care-Milwaukee West

    Wauwatosa, Wisconsin, 53226

  • Wilmot Cancer Institute at Webster

    Webster, New York, 14580

  • Moffitt Cancer Center at Wesley Chapel

    Wesley Chapel, Florida, 33544

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    West Bend, Wisconsin, 53095

  • Cleveland Clinic-Weston

    Weston, Florida, 33331

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Divine Providence Hospital

    Williamsport, Pennsylvania, 17754

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, Wisconsin, 54494

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • University of Michigan Health - West

    Wyoming, Michigan, 49519

  • WellSpan Health-York Cancer Center

    York, Pennsylvania, 17403

  • UPMC Memorial

    York, Pennsylvania, 17408

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan, 48197

Other trials in United States

Canada3 sites

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)

    Québec, Quebec, G1R 2J6

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase II Double-Blinded, Placebo-Controlled Trial of PROstate OligoMETastatic RadiotHErapy With or Without ANdrogen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean)

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Compare conventional radiological progression-free survival (rPFS) for positron emission tomography (PET)-detected, biochemically recurrent, oligometastatic, castration-sensitive prostate cancer patients treated with stereotactic ablative body radiation therapy (SABR) plus placebo versus (vs.) SABR plus relugolix.

SECONDARY OBJECTIVES:

  1. Compare conventional or PET-based radiological progression-free survival (prPFS) between treatment arms.

II. Compare patient-reported sexual and hormonal quality of life as assessed by corresponding Expanded Prostate Cancer Index Composite Short Form (EPIC-26) domains between treatment arms.

III. Compare other measures of quality of life obtained from the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ5D-5L), European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-30), Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue instruments between the two treatment arms.

IV. Compare time to salvage therapy and time to castration-resistance between treatment arms.

  1. Compare local progression (SABR-targeted lesion), biochemical progression, distant metastases, prostate cancer-specific mortality, metastasis-free survival, and overall survival between treatment arms.

VI. Determine adverse events rates and compare rates between the two treatment arms.

EXPLORATORY OBJECTIVE:

  1. Evaluate genomic and peripheral tissue and blood markers of treatment response.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive placebo orally (PO) once daily (QD) on days 1-180 and undergo SABR for 1-3 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: 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, computed tomography (CT), magnetic resonance imaging (MRI), prostate-specific membrane antigen (PSMA) positron emission tomography (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.

After completion of study treatment, patients are followed up at 9 and 12 months, subsequently every 6 months to month 60, and then annually thereafter or at the time of progression.

Being tested
Biospecimen Collection, Bone Scan, Computed Tomography, Fluciclovine F18, Magnetic Resonance Imaging
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo urine and blood sample collection

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT and/or PET/CT

  • Fluciclovine F18Other

    Also called (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBC

    Given fluciclovine F18

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI and/or PET/MRI

  • Placebo AdministrationDrug

    Given PO

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT and/or PET/MRI

  • PSMA PET ScanProcedure or surgery

    Also called Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography

    Undergo PSMA PET/CT or PET/MRI

  • RelugolixDrug

    Also called N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385

    Given PO

  • Stereotactic Body Radiation TherapyRadiation

    Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

    Undergo SABR

Study groups in NCT05053152
Study groupRoleWhat they receive
Arm I (placebo, SABR)Placebo comparatorPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Other: Fluciclovine F18; Procedure: Magnetic Resonance Imaging; Drug: Placebo Administration; Procedure: Positron Emission Tomography; Procedure: PSMA PET Scan; Radiation: Stereotactic Body Radiation Therapy
Arm II (relugolix, SABR)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Other: Fluciclovine F18; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: PSMA PET Scan; Drug: Relugolix; Radiation: Stereotactic Body Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiological progression-free survival (rPFS)

    The rPFS curves will be estimated by the Kaplan-Meier method and compared between the two treatment arms using a one-sided, logrank test stratified by the three randomization factors.

    Measured: Time from randomization to the occurrence of radiological progression detected by conventional imaging or death from any cause, assessed up to 5 years

Secondary outcomes (12)

  1. Positron emission tomography (PET)-based radiological progression-free survival

    Will be estimated by the Kaplan-Meier method and compared between treatments arms by stratified logrank test. Cox regression models will also be fit, adjusted for the stratification factors and other prognostic baseline factors, to estimate hazard ratios, together with 95% confidence intervals.

    Measured: Time from randomization to the occurrence of conventional or PET-based radiological progression or death from any cause, assessed up to 5 years

  2. Metastasis-free survival

    Will be estimated by the Kaplan-Meier method and compared between treatments arms by stratified logrank test. Cox regression models will also be fit, adjusted for the stratification factors and other prognostic baseline factors, to estimate hazard ratios, together with 95% confidence intervals.

    Measured: From randomization to distant metastases or death from any cause, assessed up to 5 years

  3. Overall survival

    Will be estimated by the Kaplan-Meier method and compared between treatments arms by stratified logrank test. Cox regression models will also be fit, adjusted for the stratification factors and other prognostic baseline factors, to estimate hazard ratios, together with 95% confidence intervals.

    Measured: From randomization to death from any cause, assessed up to 5 years

  4. Sexual and hormonal quality of life

    Assessed by Expanded Prostate Cancer Index Composite Short Form (EPIC-26).

    Measured: Up to 5 years from randomization

  5. Quality of life

    Assessed by European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ5D-5L) and European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-30).

    Measured: Up to 5 years from randomization

  6. Fatigue

    Assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue short form.

    Measured: Up to 5 years from randomization

  7. Time from randomization to administration of salvage therapy

    Will be analyzed using competing-risk methods where, in each case, death prior to occurrence of the event in question will be considered a competing risk. (In the case of death from prostate cancer, the competing risk will be non-prostate cancer death.) Cumulative incidence curves will be generated and compared using the Fine-Gray method and sub-distribution hazard ratios (SHRs) will be estimated, along with 95% confidence intervals, to summarize the magnitude of the treatment effect. In addition to Fine-Gray tests, we will estimate cause-specific hazard ratios by treating the competing risk as a censored observation via stratified logrank tests and Cox regression modelling.

    Measured: Up to 5 years from randomization

  8. Time from randomization to castrate-resistant prostate cancer

    Will be analyzed using competing-risk methods where, in each case, death prior to occurrence of the event in question will be considered a competing risk. (In the case of death from prostate cancer, the competing risk will be non-prostate cancer death.) Cumulative incidence curves will be generated and compared using the Fine-Gray method and SHRs will be estimated, along with 95% confidence intervals, to summarize the magnitude of the treatment effect. In addition to Fine-Gray tests, we will estimate cause-specific hazard ratios by treating the competing risk as a censored observation via stratified logrank tests and Cox regression modelling.

    Measured: Up to 5 years from randomization

  9. Time from randomization to local progression within a stereotactic ablative body radiation therapy (SABR)-targeted lesion

    Will be analyzed using competing-risk methods where, in each case, death prior to occurrence of the event in question will be considered a competing risk. (In the case of death from prostate cancer, the competing risk will be non-prostate cancer death.) Cumulative incidence curves will be generated and compared using the Fine-Gray method and SHRs will be estimated, along with 95% confidence intervals, to summarize the magnitude of the treatment effect. In addition to Fine-Gray tests, we will estimate cause-specific hazard ratios by treating the competing risk as a censored observation via stratified logrank tests and Cox regression modelling.

    Measured: Up to 5 years from randomization

  10. Time from randomization to biochemical progression

    Will be analyzed using competing-risk methods where, in each case, death prior to occurrence of the event in question will be considered a competing risk. (In the case of death from prostate cancer, the competing risk will be non-prostate cancer death.) Cumulative incidence curves will be generated and compared using the Fine-Gray method and SHRs will be estimated, along with 95% confidence intervals, to summarize the magnitude of the treatment effect. In addition to Fine-Gray tests, we will estimate cause-specific hazard ratios by treating the competing risk as a censored observation via stratified logrank tests and Cox regression modelling.

    Measured: Up to 5 years from randomization

  11. Time from randomization to the occurrence of distance metastases

    Will be analyzed using competing-risk methods where, in each case, death prior to occurrence of the event in question will be considered a competing risk. (In the case of death from prostate cancer, the competing risk will be non-prostate cancer death.) Cumulative incidence curves will be generated and compared using the Fine-Gray method and SHRs will be estimated, along with 95% confidence intervals, to summarize the magnitude of the treatment effect. In addition to Fine-Gray tests, we will estimate cause-specific hazard ratios by treating the competing risk as a censored observation via stratified logrank tests and Cox regression modelling.

    Measured: Up to 5 years from randomization

  12. Time from randomization to death from prostate cancer

    Will be analyzed using competing-risk methods where, in each case, death prior to occurrence of the event in question will be considered a competing risk. (In the case of death from prostate cancer, the competing risk will be non-prostate cancer death.) Cumulative incidence curves will be generated and compared using the Fine-Gray method and SHRs will be estimated, along with 95% confidence intervals, to summarize the magnitude of the treatment effect. In addition to Fine-Gray tests, we will estimate cause-specific hazard ratios by treating the competing risk as a censored observation via stratified logrank tests and Cox regression modelling.

    Measured: Up to 5 years from randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2021
  2. Study start20 Apr 2022
  3. Primary completion1 Feb 2029 (estimated)
  4. Study completion1 Feb 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
194 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05053152
Sponsor's protocol ID
NRG-GU011
Other IDs
NCI-2021-09164, NRG-GU011, NRG-GU011, U10CA180868
Status last verified
Aug 2026
First submitted
13 Sep 2021
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Bone Scan and Computed Tomography in people with Oligometastatic Prostate Carcinoma and Prostate Adenocarcinoma, run by NRG Oncology at 245 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 245 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05053152.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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