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

Purpose

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.

Conditions

  • Oligometastatic Prostate Carcinoma
  • Prostate Adenocarcinoma
  • Prostate Ductal Adenocarcinoma
  • Prostate Intraductal Carcinoma
  • Stage IVB Prostate Cancer AJCC v8

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Procedure: Biospecimen Collection
    Undergo urine and blood sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Bone Scan
    Undergo bone scan
    Other names:
    • Bone Scintigraphy
  • Procedure: Computed Tomography
    Undergo CT and/or PET/CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • tomography
  • 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:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Drug: Placebo Administration
    Given PO
  • Procedure: Positron Emission Tomography
    Undergo PET/CT and/or PET/MRI
    Other names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron emission tomography (procedure)
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • PT
  • Procedure: PSMA PET Scan
    Undergo PSMA PET/CT or PET/MRI
    Other names:
    • Prostate-specific Membrane Antigen PET
    • PSMA PET
    • PSMA-Positron emission tomography
  • Radiation: Stereotactic Body Radiation Therapy
    Undergo SABR
    Other names:
    • SABR
    • SBRT
    • Stereotactic Ablative Body Radiation Therapy
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.
  • Procedure: Biospecimen Collection
    Undergo urine and blood sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Bone Scan
    Undergo bone scan
    Other names:
    • Bone Scintigraphy
  • Procedure: Computed Tomography
    Undergo CT and/or PET/CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • tomography
  • 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:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • 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 (procedure)
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • PT
  • Procedure: PSMA PET Scan
    Undergo PSMA PET/CT or PET/MRI
    Other names:
    • Prostate-specific Membrane Antigen PET
    • PSMA PET
    • PSMA-Positron emission tomography
  • Drug: Relugolix
    Given PO
    Other names:
    • 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
    • TAK-385
    • TAK385
  • Radiation: Stereotactic Body Radiation Therapy
    Undergo SABR
    Other names:
    • SABR
    • SBRT
    • Stereotactic Ablative Body Radiation Therapy

Recruiting Locations

Cancer Center at Saint Joseph's
Phoenix, Arizona 85004
Contact:
Site Public Contact
720-874-1881
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Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
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Tower Cancer Research Foundation
Beverly Hills, California 90211
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towercancerresearch@toweroncology.com

Marin General Hospital
Greenbrae, California 94904
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415-925-7325

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612
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Site Public Contact
877-827-8839
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Cedars Sinai Medical Center
Los Angeles, California 90048
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310-423-8965

Memorial Medical Center
Modesto, California 95355
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Sutter Medical Center Sacramento
Sacramento, California 95816
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Sutter Pacific Medical Foundation
Santa Rosa, California 95403
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Sutter Solano Medical Center/Cancer Center
Vallejo, California 94589
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UCHealth University of Colorado Hospital
Aurora, Colorado 80045
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UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909
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Memorial Hospital North
Colorado Springs, Colorado 80920
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AdventHealth Porter
Denver, Colorado 80210
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Shaw Cancer Center
Edwards, Colorado 81632
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970-569-7429

Poudre Valley Hospital
Fort Collins, Colorado 80524
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Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
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412-339-5294
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Banner North Colorado Medical Center
Greeley, Colorado 80631
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UCHealth Greeley Hospital
Greeley, Colorado 80631
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UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado 80129
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AdventHealth Littleton
Littleton, Colorado 80122
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Medical Center of the Rockies
Loveland, Colorado 80538
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Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado 80539
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AdventHealth Parker
Parker, Colorado 80138
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Beebe South Coastal Health Campus
Millville, Delaware 19967
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Helen F Graham Cancer Center
Newark, Delaware 19713
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302-623-4450
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Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
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Beebe Health Campus
Rehoboth Beach, Delaware 19971
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George Washington University Medical Center
Washington D.C., District of Columbia 20037
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202-741-2210

AdventHealth Altamonte
Altamonte Springs, Florida 32701
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AdventHealth Celebration
Celebration, Florida 34747
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AdventHealth Orlando
Orlando, Florida 32803
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Moffitt Cancer Center at SouthShore
Ruskin, Florida 33570
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800-679-0775
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Moffitt Cancer Center-International Plaza
Tampa, Florida 33607
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Moffitt Cancer Center - McKinley Campus
Tampa, Florida 33612
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Moffitt Cancer Center
Tampa, Florida 33612
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Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida 33544
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Cleveland Clinic-Weston
Weston, Florida 33331
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Grady Health System
Atlanta, Georgia 30303
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Emory University Hospital Midtown
Atlanta, Georgia 30308
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Emory Saint Joseph's Hospital
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WellStar Cobb Hospital
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Emory Decatur Hospital
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Emory Johns Creek Hospital
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Wellstar Kennestone Hospital
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Alton Memorial Hospital
Alton, Illinois 62002
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Advocate Good Shepherd Hospital
Barrington, Illinois 60010
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Advocate Illinois Masonic Medical Center
Chicago, Illinois 60657
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AMG Crystal Lake - Oncology
Crystal Lake, Illinois 60014
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Carle at The Riverfront
Danville, Illinois 61832
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Decatur Memorial Hospital
Decatur, Illinois 62526
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Advocate Good Samaritan Hospital
Downers Grove, Illinois 60515
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Crossroads Cancer Center
Effingham, Illinois 62401
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Advocate Sherman Hospital
Elgin, Illinois 60123
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Advocate South Suburban Hospital
Hazel Crest, Illinois 60429
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AMG Libertyville - Oncology
Libertyville, Illinois 60048
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Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
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HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
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Advocate Christ Medical Center
Oak Lawn, Illinois 60453-2699
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Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
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Methodist Medical Center of Illinois
Peoria, Illinois 61636
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309-243-3605
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OSF Saint Francis Medical Center
Peoria, Illinois 61637
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Memorial Hospital East
Shiloh, Illinois 62269
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Springfield Memorial Hospital
Springfield, Illinois 62781
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Carle Cancer Center
Urbana, Illinois 61801
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Goshen Center for Cancer Care
Goshen, Indiana 46526
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574-364-2973
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Mary Greeley Medical Center
Ames, Iowa 50010
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515-956-4132

McFarland Clinic - Ames
Ames, Iowa 50010
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515-239-4734
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Iowa Methodist Medical Center
Des Moines, Iowa 50309
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515-241-6727

UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa 50309
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515-241-3305

The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
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502-562-3429

UofL Health Medical Center Northeast
Louisville, Kentucky 40245
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502-852-2755
ctoinfo@louisville.edu

Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809
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225-215-1353
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Mary Bird Perkins Cancer Center - Gonzales
Gonzales, Louisiana 70737
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225-215-1353
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Mary Bird Perkins Cancer Center - Metairie
Metairie, Louisiana 70002
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504-584-6990

East Jefferson General Hospital
Metairie, Louisiana 70006
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504-210-3539
emede1@lsuhsc.edu

LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana 70006
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504-210-3539
emede1@lsuhsc.edu

University Medical Center New Orleans
New Orleans, Louisiana 70112
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504-210-3539
emede1@lsuhsc.edu

Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan 48106
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734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
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734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Brighton
Brighton, Michigan 48114
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734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
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734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Canton
Canton, Michigan 48188
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734-712-7251
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Chelsea Hospital
Chelsea, Michigan 48118
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Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
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Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Michigan Healthcare Professionals Clarkston
Clarkston, Michigan 48346
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Site Public Contact
941-833-5700
rudi.ross@profoundresearch.io

Michigan Healthcare Professionals Farmington
Farmington Hills, Michigan 48334
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941-833-5700
rudi.ross@profoundresearch.io

Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan 49503
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616-391-1230
crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
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616-391-1230
crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Kalamazoo, Michigan 49007
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Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

University of Michigan Health - Sparrow Lansing
Lansing, Michigan 48912
Contact:
Site Public Contact
517-364-3712
harsha.trivedi@umhsparrow.org

Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
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Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Michigan Healthcare Professionals Macomb
Macomb, Michigan 48044
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Site Public Contact
rudi.ross@profoundresearch.io

Michigan Healthcare Professionals Madison Heights
Madison Heights, Michigan 48071
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Site Public Contact
941-833-5700
rudi.ross@profoundresearch.io

Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan 48341
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734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Corewell Health William Beaumont University Hospital
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

Munson Medical Center
Traverse City, Michigan 49684
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Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Beaumont Troy Hospital
Troy, Michigan 48085
Contact:
Site Public Contact
248-551-7695

Michigan Healthcare Professionals Troy
Troy, Michigan 48098
Contact:
Site Public Contact
rudi.ross@profoundresearch.io

University of Michigan Health - West
Wyoming, Michigan 49519
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Regions Hospital
Saint Paul, Minnesota 55101
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-334-2230
sfmc@sfmc.net

Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri 63376
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Phelps Health Delbert Day Cancer Institute
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-7504
research@phelpshealth.org

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Siteman Cancer Center-South County
St Louis, Missouri 63129
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Siteman Cancer Center at Christian Hospital
St Louis, Missouri 63136
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Benefis Sletten Cancer Institute
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
Contact:
Site Public Contact
800-639-6918
cancer.research.nurse@dartmouth.edu

University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
Contact:
Site Public Contact
505-925-0348
HSC-ClinicalTrialInfo@salud.unm.edu

Roswell Park Cancer Institute
Buffalo, New York 14263
Contact:
Site Public Contact
800-767-9355
askroswell@roswellpark.org

Highland Hospital
Rochester, New York 14620
Contact:
Site Public Contact
585-341-8113

University of Rochester
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830

Wilmot Cancer Institute at Webster
Webster, New York 14580
Contact:
Site Public Contact
WCICTOresearch@urmc.rochester.edu

East Carolina University
Greenville, North Carolina 27834
Contact:
Site Public Contact
252-744-1015
eubankss@ecu.edu

Sanford Broadway Medical Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-234-6161
OncologyClinicalTrialsFargo@sanfordhealth.org

Cleveland Clinic Akron General
Akron, Ohio 44307
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

Miami Valley Hospital South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
Site Public Contact
216-778-7559
ababal@metrohealth.org

Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Site Public Contact
800-293-5066
Jamesline@osumc.edu

Miami Valley Hospital
Dayton, Ohio 45409
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Premier Blood and Cancer Center
Dayton, Ohio 45409
Contact:
Site Public Contact
937-276-8320

Miami Valley Hospital North
Dayton, Ohio 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio 44124
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio 44136
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

ProMedica Flower Hospital
Sylvania, Ohio 43560
Contact:
Site Public Contact
419-824-1842
PCIOncResearch@promedica.org

Upper Valley Medical Center
Troy, Ohio 45373
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Oregon Health and Science University
Portland, Oregon 97239
Contact:
Site Public Contact
503-494-1080
trials@ohsu.edu

UPMC Altoona
Altoona, Pennsylvania 16601
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania 15009
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

Bryn Mawr Hospital
Bryn Mawr, Pennsylvania 19010
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Carlisle Regional Cancer Center
Carlisle, Pennsylvania 17015
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Chambersburg Hospital
Chambersburg, Pennsylvania 17201
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Geisinger Medical Center
Danville, Pennsylvania 17822
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

Ephrata Cancer Center
Ephrata, Pennsylvania 17522
Contact:
Site Public Contact
717-721-4840

UPMC Hillman Cancer Center Erie
Erie, Pennsylvania 16505
Contact:
Site Public Contact
412-864-7716
ClinicalResearchServices@upmc.edu

UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania 16121
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Adams Cancer Center
Gettysburg, Pennsylvania 17325
Contact:
Site Public Contact
877-441-7957

UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania 17109
Contact:
Site Public Contact
717-724-6765
klitchfield@PINNACLEHEALTH.org

Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
Contact:
Site Public Contact
717-531-3779
CTO@hmc.psu.edu

IRMC Cancer Center
Indiana, Pennsylvania 15701
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

Sechler Family Cancer Center
Lebanon, Pennsylvania 17042
Contact:
Site Public Contact
717-741-8303
doxenberg@wellspan.org

Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Contact:
Site Public Contact
570-374-8555
HemonCCTrials@geisinger.edu

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania 17050
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

Riddle Memorial Hospital
Media, Pennsylvania 19063
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

UPMC Hillman Cancer Center in Coraopolis
Moon Township, Pennsylvania 15108
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

Paoli Memorial Hospital
Paoli, Pennsylvania 19301
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania 15213
Contact:
Site Public Contact
412-647-2811

UPMC-Saint Margaret
Pittsburgh, Pennsylvania 15215
Contact:
Site Public Contact
412-784-4900

University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-647-8073

UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-621-2334

UPMC-Passavant Hospital
Pittsburgh, Pennsylvania 15237
Contact:
Site Public Contact
412-367-6454

Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania 17901
Contact:
Site Public Contact
800-275-6401
HemonCCTrials@geisinger.edu

UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania 16346
Contact:
Site Public Contact
814-676-7900

UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania 15301
Contact:
Site Public Contact
724-223-3788
cancer@washingtonhospital.org

Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

Divine Providence Hospital
Williamsport, Pennsylvania 17754
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Lankenau Medical Center
Wynnewood, Pennsylvania 19096
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

WellSpan Health-York Cancer Center
York, Pennsylvania 17403
Contact:
Site Public Contact
877-441-7957

UPMC Memorial
York, Pennsylvania 17408
Contact:
Site Public Contact
717-724-6760

Ralph H Johnson VA Medical Center
Charleston, South Carolina 29401
Contact:
Site Public Contact
843-789-7020
ashley.salvo@va.gov

Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Contact:
Site Public Contact
605-312-3320
OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Contact:
Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org

Covenant Medical Center-Lakeside
Lubbock, Texas 79410
Contact:
Site Public Contact
806-725-8000
jaccresearch@covhs.org

Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont 05602
Contact:
Site Public Contact
802-225-5400

University of Vermont Medical Center
Burlington, Vermont 05401
Contact:
Site Public Contact
802-656-4101
rpo@uvm.edu

Dartmouth Cancer Center - North
Saint Johnsbury, Vermont 05819
Contact:
Site Public Contact
800-639-6918
cancer.research.nurse@hitchcock.org

Bon Secours Saint Francis Medical Center
Midlothian, Virginia 23114
Contact:
Site Public Contact
804-893-8978
anne_carmellat@bshsi.org

Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia 23230
Contact:
Site Public Contact
804-893-8978
Anne_caramella@bshsi.org

VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
Contact:
Site Public Contact
ctoclinops@vcu.edu

VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
Contact:
Site Public Contact
804-628-6430
CTOclinops@vcu.edu

VCU Community Memorial Health Center
South Hill, Virginia 23970
Contact:
Site Public Contact
nemer.elmouallem@vcuhealth.org

FHCC at EvergreenHealth
Kirkland, Washington 98034
Contact:
Site Public Contact
425-899-6000

Fred Hutchinson Cancer Center
Seattle, Washington 98109
Contact:
Site Public Contact
800-804-8824

FHCC at Northwest Hospital
Seattle, Washington 98133
Contact:
Site Public Contact
206-606-5800

University of Washington Medical Center - Montlake
Seattle, Washington 98195
Contact:
Site Public Contact
800-804-8824

Edwards Comprehensive Cancer Center
Huntington, West Virginia 25701
Contact:
Site Public Contact
304-399-6566
Christina.Cole@chhi.org

Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
Contact:
Site Public Contact
715-623-9869
Juli.Alford@aspirus.org

Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin 53051
Contact:
Site Public Contact
262-257-5100

Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Site Public Contact
414-805-3666

Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center - Minocqua
Minocqua, Wisconsin 54548
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
Contact:
Site Public Contact
research.institute@phci.org

Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Drexel Town Square Health Center
Oak Creek, Wisconsin 53154
Contact:
Site Public Contact
414-805-0505

ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
Contact:
Site Public Contact
262-928-7878

Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin 54501
Contact:
Site Public Contact
715-847-2353
Beth.Knetter@aspirus.org

Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin 54481
Contact:
Site Public Contact
715-847-2353
Beth.Knetter@aspirus.org

Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Aurora Medical Center in Summit
Summit, Wisconsin 53066
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
Contact:
Site Public Contact
262-928-5539
Chanda.miller@phci.org

Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
Contact:
Site Public Contact
877-405-6866

Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora West Allis Medical Center
West Allis, Wisconsin 53227
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin 53095
Contact:
Site Public Contact
414-805-0505

Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin 54494
Contact:
Site Public Contact
715-422-7718

More Details

NCT ID
NCT05053152
Status
Recruiting
Sponsor
NRG Oncology

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.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center