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

April 28, 2026 updated by: NRG Oncology

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. 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:

I. 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.

V. 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:

I. 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.

Study Type

Interventional

Enrollment (Estimated)

194

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network-Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • CHUM - Centre Hospitalier de l'Universite de Montreal
      • Québec, Quebec, Canada, G1R 2J6
        • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Cancer Center at Saint Joseph's
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Beverly Hills, California, United States, 90211
        • Tower Cancer Research Foundation
      • Greenbrae, California, United States, 94904
        • Marin General Hospital
      • Irvine, California, United States, 92612
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
      • Los Angeles, California, United States, 90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • Los Angeles General Medical Center
      • Modesto, California, United States, 95355
        • Memorial Medical Center
      • Orange, California, United States, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Sacramento, California, United States, 95816
        • Sutter Medical Center Sacramento
      • Santa Rosa, California, United States, 95403
        • Sutter Pacific Medical Foundation
      • Vallejo, California, United States, 94589
        • Sutter Solano Medical Center/Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • UCHealth University of Colorado Hospital
      • Boulder, Colorado, United States, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Colorado Springs, Colorado, United States, 80909
        • UCHealth Memorial Hospital Central
      • Colorado Springs, Colorado, United States, 80920
        • Memorial Hospital North
      • Denver, Colorado, United States, 80210
        • AdventHealth Porter
      • Edwards, Colorado, United States, 81632
        • Shaw Cancer Center
      • Fort Collins, Colorado, United States, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, United States, 80528
        • Cancer Care and Hematology-Fort Collins
      • Greeley, Colorado, United States, 80631
        • UCHealth Greeley Hospital
      • Greeley, Colorado, United States, 80631
        • Banner North Colorado Medical Center
      • Highlands Ranch, Colorado, United States, 80129
        • UCHealth Highlands Ranch Hospital
      • Littleton, Colorado, United States, 80122
        • AdventHealth Littleton
      • Loveland, Colorado, United States, 80538
        • Medical Center of the Rockies
      • Loveland, Colorado, United States, 80539
        • Banner North Colorado Medical Center - Loveland Campus
      • Parker, Colorado, United States, 80138
        • AdventHealth Parker
    • Delaware
      • Millville, Delaware, United States, 19967
        • Beebe South Coastal Health Campus
      • Newark, Delaware, United States, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, United States, 19713
        • Medical Oncology Hematology Consultants PA
      • Rehoboth Beach, Delaware, United States, 19971
        • Beebe Health Campus
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • George Washington University Medical Center
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • AdventHealth Altamonte
      • Celebration, Florida, United States, 34747
        • AdventHealth Celebration
      • Jupiter, Florida, United States, 33458
        • Jupiter Medical Center
      • Lakewood Rch, Florida, United States, 34202
        • GenesisCare USA - Lakewood Ranch
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
      • Plantation, Florida, United States, 33324
        • GenesisCare USA - Plantation
      • Ruskin, Florida, United States, 33570
        • Moffitt Cancer Center at SouthShore
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
      • Tampa, Florida, United States, 33607
        • Moffitt Cancer Center-International Plaza
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center - McKinley Campus
      • Wesley Chapel, Florida, United States, 33544
        • Moffitt Cancer Center at Wesley Chapel
      • Weston, Florida, United States, 33331
        • Cleveland Clinic-Weston
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, United States, 30342
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, United States, 30303
        • Grady Health System
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Austell, Georgia, United States, 30106
        • WellStar Cobb Hospital
      • Decatur, Georgia, United States, 30033
        • Emory Decatur Hospital
      • Fayetteville, Georgia, United States, 30214
        • Piedmont Fayette Hospital
      • Johns Creek, Georgia, United States, 30097
        • Emory Johns Creek Hospital
      • Marietta, Georgia, United States, 30060
        • Wellstar Kennestone Hospital
    • Illinois
      • Alton, Illinois, United States, 62002
        • Alton Memorial Hospital
      • Barrington, Illinois, United States, 60010
        • Advocate Good Shepherd Hospital
      • Chicago, Illinois, United States, 60657
        • Advocate Illinois Masonic Medical Center
      • Crystal Lake, Illinois, United States, 60014
        • AMG Crystal Lake - Oncology
      • Danville, Illinois, United States, 61832
        • Carle at The Riverfront
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Downers Grove, Illinois, United States, 60515
        • Advocate Good Samaritan Hospital
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Elgin, Illinois, United States, 60123
        • Advocate Sherman Hospital
      • Hazel Crest, Illinois, United States, 60429
        • Advocate South Suburban Hospital
      • Libertyville, Illinois, United States, 60048
        • AMG Libertyville - Oncology
      • Mattoon, Illinois, United States, 61938
        • Carle Physician Group-Mattoon/Charleston
      • O'Fallon, Illinois, United States, 62269
        • HSHS Saint Elizabeth's Hospital
      • Oak Lawn, Illinois, United States, 60453-2699
        • Advocate Christ Medical Center
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
      • Shiloh, Illinois, United States, 62269
        • Memorial Hospital East
      • Springfield, Illinois, United States, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Regional Medical Center
      • Goshen, Indiana, United States, 46526
        • Goshen Center for Cancer Care
    • Iowa
      • Ames, Iowa, United States, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, United States, 50010
        • McFarland Clinic - Ames
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • The James Graham Brown Cancer Center at University of Louisville
      • Louisville, Kentucky, United States, 40245
        • UofL Health Medical Center Northeast
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center
      • Gonzales, Louisiana, United States, 70737
        • Mary Bird Perkins Cancer Center - Gonzales
      • Metairie, Louisiana, United States, 70006
        • East Jefferson General Hospital
      • Metairie, Louisiana, United States, 70006
        • LSU Healthcare Network / Metairie Multi-Specialty Clinic
      • Metairie, Louisiana, United States, 70002
        • Mary Bird Perkins Cancer Center - Metairie
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Brighton, Michigan, United States, 48114
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
      • Brighton, Michigan, United States, 48114
        • Trinity Health Medical Center - Brighton
      • Canton, Michigan, United States, 48188
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
      • Canton, Michigan, United States, 48188
        • Trinity Health Medical Center - Canton
      • Chelsea, Michigan, United States, 48118
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
      • Chelsea, Michigan, United States, 48118
        • Chelsea Hospital
      • Clarkston, Michigan, United States, 48346
        • Michigan Healthcare Professionals Clarkston
      • Farmington Hills, Michigan, United States, 48334
        • Michigan Healthcare Professionals Farmington
      • Grand Rapids, Michigan, United States, 49503
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Lansing, Michigan, United States, 48912
        • University of Michigan Health - Sparrow Lansing
      • Livonia, Michigan, United States, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Macomb, Michigan, United States, 48044
        • Michigan Healthcare Professionals Macomb
      • Madison Heights, Michigan, United States, 48071
        • Michigan Healthcare Professionals Madison Heights
      • Pontiac, Michigan, United States, 48341
        • Trinity Health Saint Joseph Mercy Oakland Hospital
      • Royal Oak, Michigan, United States, 48073
        • Corewell Health William Beaumont University Hospital
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
      • Troy, Michigan, United States, 48098
        • Michigan Healthcare Professionals Troy
      • Troy, Michigan, United States, 48085
        • Corewell Health Beaumont Troy Hospital
      • Wyoming, Michigan, United States, 49519
        • University of Michigan Health - West
      • Ypsilanti, Michigan, United States, 48197
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • City of Saint Peters, Missouri, United States, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Creve Coeur, Missouri, United States, 63141
        • Siteman Cancer Center at West County Hospital
      • Rolla, Missouri, United States, 65401
        • Phelps Health Delbert Day Cancer Institute
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, United States, 63129
        • Siteman Cancer Center-South County
      • St Louis, Missouri, United States, 63136
        • Siteman Cancer Center at Christian Hospital
    • Montana
      • Great Falls, Montana, United States, 59405
        • Benefis Sletten Cancer Institute
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital - Luckow Pavilion
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Cancer Center
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Rochester, New York, United States, 14620
        • Highland Hospital
      • Webster, New York, United States, 14580
        • Wilmot Cancer Institute at Webster
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • East Carolina University
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Akron, Ohio, United States, 44307
        • Cleveland Clinic Akron General
      • Avon, Ohio, United States, 44011
        • UH Seidman Cancer Center at UH Avon Health Center
      • Beachwood, Ohio, United States, 44122
        • UHHS-Chagrin Highlands Medical Center
      • Centerville, Ohio, United States, 45459
        • Miami Valley Hospital South
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, United States, 45409
        • Premier Blood and Cancer Center
      • Franklin, Ohio, United States, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital Cancer Center
      • Mentor, Ohio, United States, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
      • Parma, Ohio, United States, 44129
        • University Hospitals Parma Medical Center
      • Ravenna, Ohio, United States, 44266
        • University Hospitals Portage Medical Center
      • Strongsville, Ohio, United States, 44136
        • Cleveland Clinic Cancer Center Strongsville
      • Sylvania, Ohio, United States, 43560
        • ProMedica Flower Hospital
      • Troy, Ohio, United States, 45373
        • Upper Valley Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Saint Luke's Cancer Center - Allentown
      • Altoona, Pennsylvania, United States, 16601
        • UPMC Altoona
      • Beaver, Pennsylvania, United States, 15009
        • UPMC-Heritage Valley Health System Beaver
      • Bethlehem, Pennsylvania, United States, 18015
        • Saint Luke's University Hospital-Bethlehem Campus
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
      • Carlisle, Pennsylvania, United States, 17015
        • Carlisle Regional Cancer Center
      • Chadds Ford, Pennsylvania, United States, 19317
        • Christiana Care Health System-Concord Health Center
      • Chambersburg, Pennsylvania, United States, 17201
        • Chambersburg Hospital
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • East Norriton, Pennsylvania, United States, 19401
        • Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
      • Easton, Pennsylvania, United States, 18045
        • Saint Luke's Hospital-Anderson Campus
      • Ephrata, Pennsylvania, United States, 17522
        • Ephrata Cancer Center
      • Erie, Pennsylvania, United States, 16505
        • UPMC Hillman Cancer Center Erie
      • Farrell, Pennsylvania, United States, 16121
        • UPMC Cancer Center at UPMC Horizon
      • Furlong, Pennsylvania, United States, 18925
        • Fox Chase Cancer Center Buckingham
      • Gettysburg, Pennsylvania, United States, 17325
        • Adams Cancer Center
      • Harrisburg, Pennsylvania, United States, 17109
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Indiana, Pennsylvania, United States, 15701
        • IRMC Cancer Center
      • Lebanon, Pennsylvania, United States, 17042
        • Sechler Family Cancer Center
      • Lewisburg, Pennsylvania, United States, 17837
        • Geisinger Medical Oncology-Lewisburg
      • Mechanicsburg, Pennsylvania, United States, 17050
        • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
      • Media, Pennsylvania, United States, 19063
        • Riddle Memorial Hospital
      • Moon Township, Pennsylvania, United States, 15108
        • UPMC Hillman Cancer Center in Coraopolis
      • Paoli, Pennsylvania, United States, 19301
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC-Magee Womens Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Cancer Institute (UPCI)
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC-Shadyside Hospital
      • Pittsburgh, Pennsylvania, United States, 15215
        • UPMC-Saint Margaret
      • Pittsburgh, Pennsylvania, United States, 15237
        • UPMC-Passavant Hospital
      • Pottsville, Pennsylvania, United States, 17901
        • Geisinger Cancer Services-Pottsville
      • Quakertown, Pennsylvania, United States, 18951
        • Saint Luke's Hospital - Upper Bucks Campus
      • Seneca, Pennsylvania, United States, 16346
        • UPMC Cancer Center at UPMC Northwest
      • Stroudsburg, Pennsylvania, United States, 18360
        • Saint Luke's Hospital - Monroe Campus
      • Washington, Pennsylvania, United States, 15301
        • UPMC Washington Hospital Radiation Oncology
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
      • Williamsport, Pennsylvania, United States, 17754
        • Divine Providence Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
      • York, Pennsylvania, United States, 17403
        • WellSpan Health-York Cancer Center
      • York, Pennsylvania, United States, 17408
        • UPMC Memorial
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29401
        • Ralph H Johnson VA Medical Center
      • Myrtle Beach, South Carolina, United States, 29577
        • Carolina Regional Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center Oncology Clinic
    • Texas
      • Lubbock, Texas, United States, 79410
        • Covenant Medical Center-Lakeside
    • Vermont
      • Berlin Corners, Vermont, United States, 05602
        • Central Vermont Medical Center/National Life Cancer Treatment
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
      • Saint Johnsbury, Vermont, United States, 05819
        • Dartmouth Cancer Center - North
    • Virginia
      • Midlothian, Virginia, United States, 23114
        • Bon Secours Saint Francis Medical Center
      • Richmond, Virginia, United States, 23235
        • VCU Massey Cancer Center at Stony Point
      • Richmond, Virginia, United States, 23230
        • Bon Secours Cancer Institute at Reynolds Crossing
      • Richmond, Virginia, United States, 23298
        • VCU Massey Comprehensive Cancer Center
      • South Hill, Virginia, United States, 23970
        • VCU Community Memorial Health Center
    • Washington
      • Kirkland, Washington, United States, 98034
        • FHCC at EvergreenHealth
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center - Montlake
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center
      • Seattle, Washington, United States, 98133
        • FHCC at Northwest Hospital
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Edwards Comprehensive Cancer Center
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Langlade Hospital and Cancer Center
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Grafton, Wisconsin, United States, 53024
        • Aurora Cancer Care-Grafton
      • Green Bay, Wisconsin, United States, 54311
        • Aurora BayCare Medical Center
      • Marinette, Wisconsin, United States, 54143
        • Aurora Bay Area Medical Group-Marinette
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center-Marshfield
      • Menomonee Falls, Wisconsin, United States, 53051
        • Froedtert Menomonee Falls Hospital
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Saint Luke's Medical Center
      • Milwaukee, Wisconsin, United States, 53233
        • Aurora Sinai Medical Center
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Medical Center - Minocqua
      • Mukwonago, Wisconsin, United States, 53149
        • ProHealth D N Greenwald Center
      • New Richmond, Wisconsin, United States, 54017
        • Cancer Center of Western Wisconsin
      • Oak Creek, Wisconsin, United States, 53154
        • Drexel Town Square Health Center
      • Oconomowoc, Wisconsin, United States, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Oshkosh, Wisconsin, United States, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Rhinelander, Wisconsin, United States, 54501
        • Aspirus Cancer Care - James Beck Cancer Center
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Medical Center-Rice Lake
      • Sheboygan, Wisconsin, United States, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Stevens Point, Wisconsin, United States, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Stevens Point, Wisconsin, United States, 54481
        • Aspirus Cancer Care - Stevens Point
      • Summit, Wisconsin, United States, 53066
        • Aurora Medical Center in Summit
      • Waukesha, Wisconsin, United States, 53188
        • UW Cancer Center at ProHealth Care
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Regional Cancer Center
      • Wauwatosa, Wisconsin, United States, 53226
        • Aurora Cancer Care-Milwaukee West
      • West Allis, Wisconsin, United States, 53227
        • Aurora West Allis Medical Center
      • West Bend, Wisconsin, United States, 53095
        • Froedtert West Bend Hospital/Kraemer Cancer Center
      • Weston, Wisconsin, United States, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Aspirus Cancer Care - Wisconsin Rapids

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

      • 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

Exclusion Criteria:

  • 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

    • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Placebo Administration
Given PO
Radiation: Stereotactic Body Radiation Therapy
Undergo SABR
Other Names:
  • SBRT
  • SABR
  • Stereotactic Ablative Body Radiation Therapy
Procedure: Bone Scan
Undergo bone scan
Other Names:
  • Bone Scintigraphy
Procedure: Computed Tomography
Undergo CT and/or PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Procedure: Biospecimen Collection
Undergo urine and blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Fluciclovine F18
Given fluciclovine F18
Other Names:
  • (18F)Fluciclovine
  • (18F)GE-148
  • 18F-Fluciclovine
  • [18F]FACBC
  • Anti-(18f)FABC
  • Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid
  • Anti-[18F] FACBC
  • Axumin
  • Fluciclovine (18F)
  • FLUCICLOVINE F-18
  • GE-148 (18F)
  • GE-148 F-18
Procedure: Magnetic Resonance Imaging
Undergo MRI and/or PET/MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Positron Emission Tomography
Undergo PET/CT and/or PET/MRI
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • PT
  • Positron emission tomography (procedure)
Procedure: PSMA PET Scan
Undergo PSMA PET/CT or PET/MRI
Other Names:
  • PSMA PET
  • Prostate-specific Membrane Antigen PET
  • PSMA-Positron emission tomography
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.
Drug: Relugolix
Given PO
Other Names:
  • TAK-385
  • Orgovyx
  • 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
  • TAK 385
  • Relumina
  • TAK385
Radiation: Stereotactic Body Radiation Therapy
Undergo SABR
Other Names:
  • SBRT
  • SABR
  • Stereotactic Ablative Body Radiation Therapy
Procedure: Bone Scan
Undergo bone scan
Other Names:
  • Bone Scintigraphy
Procedure: Computed Tomography
Undergo CT and/or PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Procedure: Biospecimen Collection
Undergo urine and blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Fluciclovine F18
Given fluciclovine F18
Other Names:
  • (18F)Fluciclovine
  • (18F)GE-148
  • 18F-Fluciclovine
  • [18F]FACBC
  • Anti-(18f)FABC
  • Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid
  • Anti-[18F] FACBC
  • Axumin
  • Fluciclovine (18F)
  • FLUCICLOVINE F-18
  • GE-148 (18F)
  • GE-148 F-18
Procedure: Magnetic Resonance Imaging
Undergo MRI and/or PET/MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Positron Emission Tomography
Undergo PET/CT and/or PET/MRI
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • PT
  • Positron emission tomography (procedure)
Procedure: PSMA PET Scan
Undergo PSMA PET/CT or PET/MRI
Other Names:
  • PSMA PET
  • Prostate-specific Membrane Antigen PET
  • PSMA-Positron emission tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Time from randomization to the occurrence of radiological progression detected by conventional imaging or death from any cause, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positron emission tomography (PET)-based radiological progression-free survival
Time Frame: Time from randomization to the occurrence of conventional or PET-based radiological progression or death from any cause, assessed up to 5 years
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.
Time from randomization to the occurrence of conventional or PET-based radiological progression or death from any cause, assessed up to 5 years
Metastasis-free survival
Time Frame: From randomization to distant metastases or death from any cause, assessed up to 5 years
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.
From randomization to distant metastases or death from any cause, assessed up to 5 years
Overall survival
Time Frame: From randomization to death from any cause, assessed up to 5 years
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.
From randomization to death from any cause, assessed up to 5 years
Sexual and hormonal quality of life
Time Frame: Up to 5 years from randomization
Assessed by Expanded Prostate Cancer Index Composite Short Form (EPIC-26).
Up to 5 years from randomization
Quality of life
Time Frame: Up to 5 years from randomization
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).
Up to 5 years from randomization
Fatigue
Time Frame: Up to 5 years from randomization
Assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue short form.
Up to 5 years from randomization
Time from randomization to administration of salvage therapy
Time Frame: Up to 5 years from randomization
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.
Up to 5 years from randomization
Time from randomization to castrate-resistant prostate cancer
Time Frame: Up to 5 years from randomization
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.
Up to 5 years from randomization
Time from randomization to local progression within a stereotactic ablative body radiation therapy (SABR)-targeted lesion
Time Frame: Up to 5 years from randomization
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.
Up to 5 years from randomization
Time from randomization to biochemical progression
Time Frame: Up to 5 years from randomization
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.
Up to 5 years from randomization
Time from randomization to the occurrence of distance metastases
Time Frame: Up to 5 years from randomization
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.
Up to 5 years from randomization
Time from randomization to death from prostate cancer
Time Frame: Up to 5 years from randomization
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.
Up to 5 years from randomization

Other Outcome Measures

Outcome Measure
Time Frame
Genomic, peripheral tissue, and blood biomarkers
Time Frame: Up to 5 years from randomization
Up to 5 years from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NRG Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Bridget F Koontz, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2022

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRG-GU011 (Other Identifier: CTEP)
  • U10CA180868 (U.S. NIH Grant/Contract)
  • NCI-2021-09164 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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