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

NCT ID: NCT05053152

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-20

Study Completion Date

2029-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Undergo urine and blood sample collection

Bone Scan

Intervention Type PROCEDURE

Undergo bone scan

Computed Tomography

Intervention Type PROCEDURE

Undergo CT and/or PET/CT

Fluciclovine F18

Intervention Type OTHER

Given fluciclovine F18

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI and/or PET/MRI

Placebo Administration

Intervention Type DRUG

Given PO

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT and/or PET/MRI

PSMA PET Scan

Intervention Type PROCEDURE

Undergo PSMA PET/CT or PET/MRI

Stereotactic Body Radiation Therapy

Intervention Type RADIATION

Undergo SABR

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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo urine and blood sample collection

Bone Scan

Intervention Type PROCEDURE

Undergo bone scan

Computed Tomography

Intervention Type PROCEDURE

Undergo CT and/or PET/CT

Fluciclovine F18

Intervention Type OTHER

Given fluciclovine F18

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI and/or PET/MRI

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT and/or PET/MRI

PSMA PET Scan

Intervention Type PROCEDURE

Undergo PSMA PET/CT or PET/MRI

Relugolix

Intervention Type DRUG

Given PO

Stereotactic Body Radiation Therapy

Intervention Type RADIATION

Undergo SABR

Interventions

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Biospecimen Collection

Undergo urine and blood sample collection

Intervention Type PROCEDURE

Bone Scan

Undergo bone scan

Intervention Type PROCEDURE

Computed Tomography

Undergo CT and/or PET/CT

Intervention Type PROCEDURE

Fluciclovine F18

Given fluciclovine F18

Intervention Type OTHER

Magnetic Resonance Imaging

Undergo MRI and/or PET/MRI

Intervention Type PROCEDURE

Placebo Administration

Given PO

Intervention Type DRUG

Positron Emission Tomography

Undergo PET/CT and/or PET/MRI

Intervention Type PROCEDURE

PSMA PET Scan

Undergo PSMA PET/CT or PET/MRI

Intervention Type PROCEDURE

Relugolix

Given PO

Intervention Type DRUG

Stereotactic Body Radiation Therapy

Undergo SABR

Intervention Type RADIATION

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection Bone Scintigraphy CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan tomography (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 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 Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography PT Prostate-specific Membrane Antigen PET PSMA PET PSMA-Positron emission tomography 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 SABR SBRT Stereotactic Ablative Body Radiation Therapy

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

NRG Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bridget F Koontz

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

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Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Site Status RECRUITING

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Site Status RECRUITING

Tower Cancer Research Foundation

Beverly Hills, California, United States

Site Status RECRUITING

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Site Status RECRUITING

Los Angeles General Medical Center

Los Angeles, California, United States

Site Status ACTIVE_NOT_RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status ACTIVE_NOT_RECRUITING

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Memorial Medical Center

Modesto, California, United States

Site Status RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status ACTIVE_NOT_RECRUITING

Sutter Medical Center Sacramento

Sacramento, California, United States

Site Status RECRUITING

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Site Status RECRUITING

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

Site Status RECRUITING

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status RECRUITING

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Site Status RECRUITING

Memorial Hospital North

Colorado Springs, Colorado, United States

Site Status RECRUITING

AdventHealth Porter

Denver, Colorado, United States

Site Status RECRUITING

Shaw Cancer Center

Edwards, Colorado, United States

Site Status RECRUITING

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status RECRUITING

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

Site Status RECRUITING

Banner North Colorado Medical Center

Greeley, Colorado, United States

Site Status SUSPENDED

UCHealth Greeley Hospital

Greeley, Colorado, United States

Site Status RECRUITING

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, United States

Site Status RECRUITING

AdventHealth Littleton

Littleton, Colorado, United States

Site Status RECRUITING

Medical Center of the Rockies

Loveland, Colorado, United States

Site Status RECRUITING

Banner McKee Medical Center

Loveland, Colorado, United States

Site Status SUSPENDED

AdventHealth Parker

Parker, Colorado, United States

Site Status RECRUITING

Beebe South Coastal Health Campus

Millville, Delaware, United States

Site Status RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status RECRUITING

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Site Status RECRUITING

George Washington University Medical Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

AdventHealth Altamonte

Altamonte Springs, Florida, United States

Site Status RECRUITING

AdventHealth Celebration

Celebration, Florida, United States

Site Status RECRUITING

Jupiter Medical Center

Jupiter, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

GenesisCare USA - Lakewood Ranch

Lakewood Rch, Florida, United States

Site Status SUSPENDED

AdventHealth Orlando

Orlando, Florida, United States

Site Status RECRUITING

GenesisCare USA - Plantation

Plantation, Florida, United States

Site Status SUSPENDED

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Cleveland Clinic-Weston

Weston, Florida, United States

Site Status RECRUITING

Grady Health System

Atlanta, Georgia, United States

Site Status RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status RECRUITING

Piedmont Hospital

Atlanta, Georgia, United States

Site Status SUSPENDED

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status RECRUITING

WellStar Cobb Hospital

Austell, Georgia, United States

Site Status RECRUITING

Emory Decatur Hospital

Decatur, Georgia, United States

Site Status RECRUITING

Piedmont Fayette Hospital

Fayetteville, Georgia, United States

Site Status SUSPENDED

Emory Johns Creek Hospital

Johns Creek, Georgia, United States

Site Status RECRUITING

Wellstar Kennestone Hospital

Marietta, Georgia, United States

Site Status RECRUITING

Alton Memorial Hospital

Alton, Illinois, United States

Site Status RECRUITING

Advocate Good Shepherd Hospital

Barrington, Illinois, United States

Site Status RECRUITING

Advocate Illinois Masonic Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, United States

Site Status RECRUITING

Carle at The Riverfront

Danville, Illinois, United States

Site Status RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status RECRUITING

Advocate Good Samaritan Hospital

Downers Grove, Illinois, United States

Site Status RECRUITING

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status RECRUITING

Advocate Sherman Hospital

Elgin, Illinois, United States

Site Status RECRUITING

Advocate South Suburban Hospital

Hazel Crest, Illinois, United States

Site Status RECRUITING

AMG Libertyville - Oncology

Libertyville, Illinois, United States

Site Status RECRUITING

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Site Status RECRUITING

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, United States

Site Status RECRUITING

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Site Status RECRUITING

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Site Status RECRUITING

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status RECRUITING

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status RECRUITING

Memorial Hospital East

Shiloh, Illinois, United States

Site Status RECRUITING

Springfield Memorial Hospital

Springfield, Illinois, United States

Site Status RECRUITING

Carle Cancer Center

Urbana, Illinois, United States

Site Status RECRUITING

Parkview Regional Medical Center

Fort Wayne, Indiana, United States

Site Status ACTIVE_NOT_RECRUITING

Goshen Center for Cancer Care

Goshen, Indiana, United States

Site Status RECRUITING

Mary Greeley Medical Center

Ames, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Ames

Ames, Iowa, United States

Site Status RECRUITING

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Site Status RECRUITING

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

Site Status RECRUITING

UofL Health Medical Center Northeast

Louisville, Kentucky, United States

Site Status RECRUITING

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Site Status RECRUITING

Mary Bird Perkins Cancer Center - Gonzales

Gonzales, Louisiana, United States

Site Status RECRUITING

Mary Bird Perkins Cancer Center - Metairie

Metairie, Louisiana, United States

Site Status RECRUITING

East Jefferson General Hospital

Metairie, Louisiana, United States

Site Status RECRUITING

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, United States

Site Status SUSPENDED

University Medical Center New Orleans

New Orleans, Louisiana, United States

Site Status RECRUITING

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Site Status RECRUITING

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Site Status RECRUITING

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Site Status RECRUITING

Chelsea Hospital

Chelsea, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Site Status RECRUITING

Michigan Healthcare Professionals Clarkston

Clarkston, Michigan, United States

Site Status RECRUITING

Michigan Healthcare Professionals Farmington

Farmington Hills, Michigan, United States

Site Status RECRUITING

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Site Status RECRUITING

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Site Status RECRUITING

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status RECRUITING

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Site Status RECRUITING

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Site Status RECRUITING

Michigan Healthcare Professionals Macomb

Macomb, Michigan, United States

Site Status RECRUITING

Michigan Healthcare Professionals Madison Heights

Madison Heights, Michigan, United States

Site Status RECRUITING

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Site Status RECRUITING

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Site Status RECRUITING

Munson Medical Center

Traverse City, Michigan, United States

Site Status RECRUITING

Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States

Site Status RECRUITING

Michigan Healthcare Professionals Troy

Troy, Michigan, United States

Site Status RECRUITING

University of Michigan Health - West

Wyoming, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Site Status RECRUITING

Regions Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Site Status RECRUITING

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center-South County

St Louis, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Site Status RECRUITING

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Site Status RECRUITING

The Valley Hospital - Luckow Pavilion

Paramus, New Jersey, United States

Site Status ACTIVE_NOT_RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status SUSPENDED

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status RECRUITING

Highland Hospital

Rochester, New York, United States

Site Status RECRUITING

University of Rochester

Rochester, New York, United States

Site Status RECRUITING

Wilmot Cancer Institute at Webster

Webster, New York, United States

Site Status RECRUITING

East Carolina University

Greenville, North Carolina, United States

Site Status RECRUITING

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Site Status RECRUITING

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status RECRUITING

UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Miami Valley Hospital South

Centerville, Ohio, United States

Site Status RECRUITING

Case Western Reserve University

Cleveland, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, United States

Site Status RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

Miami Valley Hospital

Dayton, Ohio, United States

Site Status RECRUITING

Premier Blood and Cancer Center

Dayton, Ohio, United States

Site Status RECRUITING

Miami Valley Hospital North

Dayton, Ohio, United States

Site Status RECRUITING

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Site Status RECRUITING

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, United States

Site Status RECRUITING

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

University Hospitals Parma Medical Center

Parma, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

University Hospitals Portage Medical Center

Ravenna, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Cleveland Clinic Cancer Center Strongsville

Strongsville, Ohio, United States

Site Status RECRUITING

ProMedica Flower Hospital

Sylvania, Ohio, United States

Site Status RECRUITING

Upper Valley Medical Center

Troy, Ohio, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

UPMC Altoona

Altoona, Pennsylvania, United States

Site Status RECRUITING

UPMC-Heritage Valley Health System Beaver

Beaver, Pennsylvania, United States

Site Status RECRUITING

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Site Status RECRUITING

Carlisle Regional Cancer Center

Carlisle, Pennsylvania, United States

Site Status RECRUITING

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, United States

Site Status RECRUITING

Chambersburg Hospital

Chambersburg, Pennsylvania, United States

Site Status RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status RECRUITING

Fox Chase Cancer Center - East Norriton Hospital Outpatient Center

East Norriton, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Ephrata Cancer Center

Ephrata, Pennsylvania, United States

Site Status RECRUITING

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, United States

Site Status RECRUITING

UPMC Cancer Center at UPMC Horizon

Farrell, Pennsylvania, United States

Site Status RECRUITING

Fox Chase Cancer Center Buckingham

Furlong, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Adams Cancer Center

Gettysburg, Pennsylvania, United States

Site Status RECRUITING

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, United States

Site Status RECRUITING

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status RECRUITING

IRMC Cancer Center

Indiana, Pennsylvania, United States

Site Status RECRUITING

Sechler Family Cancer Center

Lebanon, Pennsylvania, United States

Site Status RECRUITING

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, United States

Site Status RECRUITING

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, United States

Site Status RECRUITING

Riddle Memorial Hospital

Media, Pennsylvania, United States

Site Status RECRUITING

UPMC Hillman Cancer Center in Coraopolis

Moon Township, Pennsylvania, United States

Site Status RECRUITING

Paoli Memorial Hospital

Paoli, Pennsylvania, United States

Site Status RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Geisinger Cancer Services-Pottsville

Pottsville, Pennsylvania, United States

Site Status RECRUITING

UPMC Cancer Center at UPMC Northwest

Seneca, Pennsylvania, United States

Site Status RECRUITING

UPMC Washington Hospital Radiation Oncology

Washington, Pennsylvania, United States

Site Status RECRUITING

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Site Status RECRUITING

Divine Providence Hospital

Williamsport, Pennsylvania, United States

Site Status RECRUITING

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Site Status RECRUITING

WellSpan Health-York Cancer Center

York, Pennsylvania, United States

Site Status RECRUITING

UPMC Memorial

York, Pennsylvania, United States

Site Status RECRUITING

Ralph H Johnson VA Medical Center

Charleston, South Carolina, United States

Site Status RECRUITING

Carolina Regional Cancer Center

Myrtle Beach, South Carolina, United States

Site Status SUSPENDED

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Covenant Medical Center-Lakeside

Lubbock, Texas, United States

Site Status RECRUITING

Central Vermont Medical Center/National Life Cancer Treatment

Berlin Corners, Vermont, United States

Site Status RECRUITING

University of Vermont Medical Center

Burlington, Vermont, United States

Site Status RECRUITING

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, United States

Site Status RECRUITING

Bon Secours Saint Francis Medical Center

Midlothian, Virginia, United States

Site Status RECRUITING

Bon Secours Cancer Institute at Reynolds Crossing

Richmond, Virginia, United States

Site Status RECRUITING

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

Site Status RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Site Status RECRUITING

VCU Community Memorial Health Center

South Hill, Virginia, United States

Site Status RECRUITING

FHCC at EvergreenHealth

Kirkland, Washington, United States

Site Status RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Site Status RECRUITING

FHCC at Northwest Hospital

Seattle, Washington, United States

Site Status RECRUITING

University of Washington Medical Center - Montlake

Seattle, Washington, United States

Site Status RECRUITING

Edwards Comprehensive Cancer Center

Huntington, West Virginia, United States

Site Status RECRUITING

Langlade Hospital and Cancer Center

Antigo, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Site Status RECRUITING

Aurora Cancer Care-Grafton

Grafton, Wisconsin, United States

Site Status RECRUITING

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Site Status RECRUITING

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Site Status RECRUITING

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, United States

Site Status RECRUITING

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States

Site Status RECRUITING

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States

Site Status RECRUITING

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

Site Status RECRUITING

Drexel Town Square Health Center

Oak Creek, Wisconsin, United States

Site Status RECRUITING

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

Site Status RECRUITING

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, United States

Site Status RECRUITING

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Site Status RECRUITING

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, United States

Site Status RECRUITING

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Site Status RECRUITING

Aurora Medical Center in Summit

Summit, Wisconsin, United States

Site Status RECRUITING

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Site Status RECRUITING

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Site Status RECRUITING

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, United States

Site Status RECRUITING

Aurora West Allis Medical Center

West Allis, Wisconsin, United States

Site Status RECRUITING

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

Site Status RECRUITING

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, United States

Site Status RECRUITING

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Site Status RECRUITING

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

Québec, Quebec, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2021-09164

Identifier Type: REGISTRY

Identifier Source: secondary_id

NRG-GU011

Identifier Type: OTHER

Identifier Source: secondary_id

NRG-GU011

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180868

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NRG-GU011

Identifier Type: -

Identifier Source: org_study_id