Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score
Study Details
Study Description
Brief Summary
This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors. Androgen deprivation therapy blocks the production or interferes with the action of male sex hormones such as testosterone, which plays a role in prostate cancer development. Giving radiation treatment alone may be the same as the usual approach in controlling the cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy. In patients with higher Decipher gene risk, this trial compares the addition of darolutamide to usual treatment radiation therapy and hormone therapy, to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
PRIMARY OBJECTIVES:
- To determine whether men with National Comprehensive Cancer Network (NCCN) unfavorable intermediate risk (UIR) prostate cancer and lower Decipher genomic risk (Decipher score < 0.40) treated with radiation therapy (RT) alone instead of 6 months androgen deprivation therapy (ADT) + RT experience non-inferior rate of distant metastasis. (De-intensification study) II. To determine whether men with NCCN UIR prostate cancer who are in the higher genomic risk (Decipher score >= 0.40) will have a superior metastasis-free survival through treatment intensification with darolutamide added to the standard of RT plus 6 months ADT. (Intensification study)
SECONDARY OBJECTIVES:
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To compare overall survival (OS) between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
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To compare time to prostate specific antigen (PSA) failure between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
-
To compare metastasis free survival (MFS) based on conventional imaging between the standard of care (RT plus 6 months of ADT) and de-intensification intervention (RT alone).
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To compare MFS based on either conventional and/or molecular imaging between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
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To compare cumulative incidence of locoregional failure based upon conventional imaging and/ or biopsy between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months ADT plus darolutamide) interventions.
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To compare cumulative incidence of distant metastasis based upon conventional imaging between standard of care (RT plus 6 months of ADT) and intensification intervention (RT plus 6 months ADT plus darolutamide).
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To compare cumulative incidence of distant metastasis based upon either conventional and/or molecular imaging between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
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To compare prostate cancer-specific mortality between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
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To compare sexual and hormonal related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
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To compare fatigue, as measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue instrument, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
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To compare cognition, as measured by the Functional Assessment of Chronic Illness Therapy-Cognitive (FACT-Cog) perceived cognitive abilities subscale, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
EXPLORATORY OBJECTIVES:
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To compare changes in cardio-metabolic markers, including body mass index, lipids, blood glucose, complete blood count (CBC), comprehensive metabolic panel (CMP), and hemoglobin (Hgb) A1c, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
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To compare PSA failure-free survival with non-castrate testosterone and no additional therapies between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
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To compare cumulative incidence of locoregional failure based upon either conventional and/or molecular imaging between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
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To compare castrate-resistant prostate cancer (CRPC) between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
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To compare bowel and urinary function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
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To compare time to testosterone recovery (defined as a T > 200ng/dL) between the standard of care (RT plus 6 months of ADT) and intensification (RT plus 6 months of ADT plus darolutamide) interventions.
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To compare health utilities, as measured by the European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L), between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
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To develop and assess a machine learning/artificial intelligence algorithm for radiotherapy planning and/or quality assurance.
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To perform future translational correlative studies using biological data, Decipher results, and clinical outcomes.
OUTLINE:
DE-INTENSIFICATION STUDY: Patients with Decipher score < 0.40 are randomized to 1 of 2 arms.
ARM I: Patients undergo RT using a recognized regimen (2-3 days a week or 5 days a week for 2-11 weeks) in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo RT as Arm I. Patients also receive ADT consisting of leuprolide, goserelin, buserelin, histrelin, triptorelin, degarelix, or relugolix at the discretion of the treating physician, for 6 months in the absence of disease progression or unacceptable toxicity. Patients may also receive bicalutamide or flutamide for 0, 30 or 180 days.
INTENSIFICATION STUDY: Patients with Decipher score >= 0.40 are randomized to 1 of 2 arms.
ARM III: Patients receive treatment as in Arm II.
ARM IV: Patients receive RT and ADT as in Arm II. Patients also receive darolutamide orally (PO) twice daily (BID). Treatment repeats every 90 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3, 6, 12, 24, 36, 48 and 60 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I (RT) Patients undergo RT using a recognized regimen (2-3 days a week or 5 days a week for 2-11 weeks) in the absence of disease progression or unacceptable toxicity. |
Radiation: Radiation Therapy
Undergo RT
Other Names:
|
| Experimental: Arm II (RT, ADT) Patients undergo RT as Arm I. Patients also receive ADT consisting of leuprolide, goserelin, buserelin, histrelin, triptorelin, degarelix, or relugolix at the discretion of the treating physician, for 6 months in the absence of disease progression or unacceptable toxicity. Patients may also receive bicalutamide or flutamide for 0, 30 or 180 days. |
Drug: Bicalutamide
Anti-androgen
Other Names:
Drug: Buserelin
GnRH agonist
Other Names:
Drug: Degarelix
GnRH antagonist
Other Names:
Drug: Flutamide
Anti-androgen
Other Names:
Drug: Goserelin
GnRH agonist
Other Names:
Drug: Histrelin
GnRH agonist
Drug: Leuprolide
GnRH agonist
Other Names:
Radiation: Radiation Therapy
Undergo RT
Other Names:
Drug: Relugolix
GnRH antagonist
Other Names:
Drug: Triptorelin
GnRH agonist
Other Names:
|
| Experimental: Arm III (RT, ADT) Patients receive treatment as in Arm II. |
Drug: Bicalutamide
Anti-androgen
Other Names:
Drug: Buserelin
GnRH agonist
Other Names:
Drug: Degarelix
GnRH antagonist
Other Names:
Drug: Flutamide
Anti-androgen
Other Names:
Drug: Goserelin
GnRH agonist
Other Names:
Drug: Histrelin
GnRH agonist
Drug: Leuprolide
GnRH agonist
Other Names:
Radiation: Radiation Therapy
Undergo RT
Other Names:
Drug: Relugolix
GnRH antagonist
Other Names:
Drug: Triptorelin
GnRH agonist
Other Names:
|
| Experimental: Arm IV (RT, ADT, darolutamide) Patients receive RT and ADT as in Arm II. Patients also receive darolutamide PO BID on days 1-90. Treatment repeats every 90 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. |
Drug: Buserelin
GnRH agonist
Other Names:
Drug: Darolutamide
Anti-androgen
Other Names:
Drug: Degarelix
GnRH antagonist
Other Names:
Drug: Goserelin
GnRH agonist
Other Names:
Drug: Histrelin
GnRH agonist
Drug: Leuprolide
GnRH agonist
Other Names:
Radiation: Radiation Therapy
Undergo RT
Other Names:
Drug: Relugolix
GnRH antagonist
Other Names:
Drug: Triptorelin
GnRH agonist
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Distant Metastasis (DM) (De-intensification study) [From randomization to the detection of distant metastasis by conventional imaging, assessed up to 5 years]
Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.
- Metastasis-Free Survival (MFS) (Intensification study) [From randomization until the occurrence of distant metastasis by conventional imaging or death from any cause, assessed up to 5 years]
MFS will be estimated by the Kaplan-Meier (1958) method and compared between the two treatment arms using a stratified log-rank test (stratified by the randomization stratification factors) at one-sided alpha level of 0.025.
Secondary Outcome Measures
- Overall Survival [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 log-rank test. Cox regression models will also be fit, adjusted for the stratification factors, to estimate hazard ratios, together with 95% confidence intervals.
- Time to Prostate Specific Antigen (PSA) failure [Up to 5 years]
Defined as PSA > 2 ng/ml above the nadir post randomization. Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.
- MFS (De-intensification study) [From randomization until the occurrence of distant metastasis by conventional imaging 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 log-rank test. Cox regression models will also be fit, adjusted for the stratification factors, to estimate hazard ratios, together with 95% confidence intervals.
- MFS including positron emission tomography (PET) imaging [From randomization until the occurrence of distant metastasis by conventional and/or molecular imaging 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 log-rank test.
- Locoregional failure (LRF) [From randomization until local or regional recurrence based upon conventional imaging or biopsy, assessed up to 5 years]
Will compare cumulative incidence between arms.
- DM including PET imaging [From randomization to the detection of distant metastasis by conventional and/or molecular imaging, assessed up to 5 years]
Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.
- Prostate cancer-specific mortality [From randomization until death from prostate cancer, assessed up to 5 years]
Will be analyzed using competing-risk methods (Gooley 1999) where, in each case death from causes other than prostate cancer as the competing risk.
- Sexual and hormonal function related quality of life [Up to 5 years]
Measured by the Expanded Prostate Cancer Index Composite-26 (EPIC-26).
- Fatigue [Up to 5 years]
Measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue instrument.
- Cognition [Up to 5 years]
Measured by the Functional Assessment of Chronic illness Therapy-Cognitive (FACT-Cog).
- DM (Intensification study) [From randomization to the detection of distant metastasis by conventional imaging, assessed up to 5 years]
Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.
- Locoregional progression [Up to 5 years]
Defined as defined as recurrence within the pelvis including lymph nodes below the iliac bifurcation, or prostate. Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.
Other Outcome Measures
- Castrate-resistant prostate cancer (CRPC) [Up to 5 years]
CRPC is defined as PSA increase > 25% and more than 2 ng/mL above nadir on study in conjunction with a serum testosterone (T) < 50 ng/mL, confirmed by repeat measurements at least 2 weeks apart. Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.
- Bowel and urinary function related quality of life [Up to 5 years]
Measured EPIC-26. Mixed effect regression models will be fit to compare the changes over time in the domain scores. Covariates will include treatment, time, and treatment-by-time treatment interaction terms.
- Cardio-metabolic markers [Up to 5 years]
Will include body mass index, lipids, blood glucose, complete blood count, comprehensive metabolic panel, and hemoglobin A1c. Mixed effect regression models will be fit to compare the changes over time in the cardio-metabolic markers between treatment groups. Covariates will include treatment, time, and treatment-by-time treatment interaction terms.
- PSA failure-free survival with non-castrate testosterone and no additional therapies [Up to 5 years]
- Locoregional failure based upon either conventional or molecular imaging [Up to 5 years]
- Health utilities [Up to 5 years]
Measured by the European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L). ). The bootstrap (Efron 1980) will be performed to obtain standard errors, test for significant differences, and generate 95% confidence intervals.
- Time to testosterone recovery [From randomization until T > 200 ng/dL, assessed up to 5 years]
Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk. Changes in quality of life measures will be correlated with changes in testosterone levels.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of the prostate within 270 days prior to registration
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Unfavorable intermediate risk prostate cancer, defined as having ALL the following bulleted criteria:
-
Has at least one intermediate risk factor (IRF):
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PSA 10-20 ng/mL
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Clinical stage T2b-c (digital rectal examination [DRE] and/or imaging) by American Joint Committee on Cancer (AJCC) 8th edition
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Gleason score 7 (Gleason 3+4 or 4+3 [ International Society of Urological Pathology (ISUP) Grade Group 2-3])
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Has ONE or more of the following 'unfavorable' intermediate-risk designators:
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1 immature reticulocyte fraction (IRF)
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Gleason 4+3=7 (ISUP Grade Group 3)
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= 50% of biopsy cores positive
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Biopsies may include 'sextant' sampling of right/left regions of the prostate, often labeled base, mid-gland and apex. All such 'sextant' biopsy cores should be counted. Men may also undergo 'targeted' sampling of prostate lesions (guided by MRI, ultrasound or other approaches). A targeted lesion that is biopsied more than once and demonstrates cancer (regardless of number of targeted cores involved) should count as a single additional positive core sampled and positive. In cases of uncertainty, count the biopsy sampling as sextant core(s)
-
Absence of high-risk features
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Appropriate stage for study entry based on the following diagnostic workup:
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History/physical examination within 120 days prior to registration;
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Negative bone imaging (M0) within 120 days prior to registration; Note: Tc-99m bone scan or sodium fluoride (NaF) positron emission tomography (PET) are allowed. Equivocal bone scan findings are allowed if plain films X-ray, computed tomography (CT) or magnetic resonance imaging (MRI) are negative for metastasis at the concerned site(s). While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for bone imaging, any suspicious findings must be confirmed and correlated with conventional imaging (Tc-99m bone scan, NaF PET, CT, X-ray, or MRI) to determine eligibility based on the latter modalities (e.g. M0 based on conventional imaging modalities)
-
Clinically negative lymph nodes (N0) as established by conventional imaging (pelvic +/- abdominal CT or MR), within 120 days prior to registration. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< 1.0 cm in short axis and/or if biopsy is negative.
Note: While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for pelvic imaging, any suspicious findings must be confirmed by conventional imaging (CT, MRI or biopsy). If the findings do not meet pathological criteria based on the latter modalities (e.g. node =< 10 mm in short axis, negative biopsy), the patient will still be eligible
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Age >= 18
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration
-
Non-castrate testosterone level (> 50 ng/dL) within 120 days prior to registration
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Absolute neutrophil >= 1,000 cells/mm^3 (within 120 days prior to registration)
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Hemoglobin >= 8.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration)
-
Platelet count >= 100,000 cells/mm^3 independent of transfusion and/or growth factors (within 120 days prior to registration)
-
Creatinine clearance (CrCl) >= 30 mL/min estimated by Cockcroft-Gault equation (within 120 days prior to registration)
-
For African American patients specifically whose renal function is not considered adequate by the formula above, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) should be used for calculating the related estimated glomerular filtration rate (GFR) with a correction factor for African American race creatinine clearance for trial eligibility, where GFR >= 30 mL/min/1.73m^2 will be considered adequate
-
Total bilirubin: 1.5 =< institutional upper limit of normal (ULN) (within 120 days prior to registration) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin. If direct bilirubin is less than or equal to 1.5 x ULN, subject is eligible)
-
Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]): =< 2.5 x institutional ULN (within 120 days prior to registration)
-
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial; Note: HIV testing is not required for eligibility for this protocol
-
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)
-
For 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
-
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:
-
Previous radical surgery (prostatectomy) or any form of curative-intent ablation whether focal or whole-gland (e.g., cryosurgery, high intensity focused ultrasound [HIFU], laser thermal ablation, etc.) for prostate cancer
-
Definitive clinical or radiologic evidence of metastatic disease (M1)
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Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. History of or current diagnosis of hematologic malignancy is not allowed
-
Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields
-
Previous bilateral orchiectomy
-
Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate). ADT started prior to study registration is not allowed
-
Prior use of 5-alpha-reductase inhibitors is allowed, however, it must be stopped prior to enrollment on the study with at least a 30 day washout period before baseline study PSA measure and registration
-
Active testosterone replacement therapy; any replacement therapy must be stopped at least 30 days prior to registration
-
Severe, active co-morbidity defined as follows:
-
Current severe or unstable angina;
-
New York Heart Association Functional Classification III/IV (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)
-
History of any condition that in the opinion of the investigator, would preclude participation in this study
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Inability to swallow oral pills
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High risk features, which includes any of the following:
-
Gleason 8-10 [ISUP Grade Group 4-5]
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PSA > 20
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cT3-4 by digital exam OR gross extra-prostatic extension on imaging [indeterminate MRI evidence will not count and the patient will be eligible]
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | United States | 35233 |
| 2 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 3 | Tower Cancer Research Foundation | Beverly Hills | California | United States | 90211 |
| 4 | Marin General Hospital | Greenbrae | California | United States | 94904 |
| 5 | Los Angeles County-USC Medical Center | Los Angeles | California | United States | 90033 |
| 6 | USC / Norris Comprehensive Cancer Center | Los Angeles | California | United States | 90033 |
| 7 | Cedars Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 8 | Torrance Memorial Physician Network - Cancer Care | Torrance | California | United States | 90505 |
| 9 | Torrance Memorial Medical Center | Torrance | California | United States | 90509 |
| 10 | Gene Upshaw Memorial Tahoe Forest Cancer Center | Truckee | California | United States | 96161 |
| 11 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
| 12 | Rocky Mountain Cancer Centers-Boulder | Boulder | Colorado | United States | 80304 |
| 13 | UCHealth Memorial Hospital Central | Colorado Springs | Colorado | United States | 80909 |
| 14 | Memorial Hospital North | Colorado Springs | Colorado | United States | 80920 |
| 15 | Poudre Valley Hospital | Fort Collins | Colorado | United States | 80524 |
| 16 | Cancer Care and Hematology-Fort Collins | Fort Collins | Colorado | United States | 80528 |
| 17 | UCHealth Greeley Hospital | Greeley | Colorado | United States | 80631 |
| 18 | Medical Center of the Rockies | Loveland | Colorado | United States | 80538 |
| 19 | Beebe South Coastal Health Campus | Frankford | Delaware | United States | 19945 |
| 20 | Helen F Graham Cancer Center | Newark | Delaware | United States | 19713 |
| 21 | Medical Oncology Hematology Consultants PA | Newark | Delaware | United States | 19713 |
| 22 | Beebe Health Campus | Rehoboth Beach | Delaware | United States | 19971 |
| 23 | GenesisCare USA - Plantation | Plantation | Florida | United States | 33324 |
| 24 | Piedmont Hospital | Atlanta | Georgia | United States | 30309 |
| 25 | Piedmont Fayette Hospital | Fayetteville | Georgia | United States | 30214 |
| 26 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 27 | Carle on Vermilion | Danville | Illinois | United States | 61832 |
| 28 | Decatur Memorial Hospital | Decatur | Illinois | United States | 62526 |
| 29 | Northwestern Medicine Cancer Center Kishwaukee | DeKalb | Illinois | United States | 60115 |
| 30 | Crossroads Cancer Center | Effingham | Illinois | United States | 62401 |
| 31 | Elmhurst Memorial Hospital | Elmhurst | Illinois | United States | 60126 |
| 32 | Northwestern Medicine Cancer Center Delnor | Geneva | Illinois | United States | 60134 |
| 33 | Northwestern Medicine Lake Forest Hospital | Lake Forest | Illinois | United States | 60045 |
| 34 | Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | United States | 61938 |
| 35 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 36 | Edward Hospital/Cancer Center | Naperville | Illinois | United States | 60540 |
| 37 | Memorial Medical Center | Springfield | Illinois | United States | 62781 |
| 38 | Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 39 | Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois | United States | 60555 |
| 40 | Saint Luke's Hospital | Cedar Rapids | Iowa | United States | 52402 |
| 41 | Iowa Methodist Medical Center | Des Moines | Iowa | United States | 50309 |
| 42 | University of Kansas Cancer Center | Kansas City | Kansas | United States | 66160 |
| 43 | University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | United States | 66210 |
| 44 | University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | United States | 66205 |
| 45 | Ascension Via Christi Hospitals Wichita | Wichita | Kansas | United States | 67214 |
| 46 | East Jefferson General Hospital | Metairie | Louisiana | United States | 70006 |
| 47 | LSU Healthcare Network / Metairie Multi-Specialty Clinic | Metairie | Louisiana | United States | 70006 |
| 48 | Saint Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
| 49 | Saint Joseph Mercy Brighton | Brighton | Michigan | United States | 48114 |
| 50 | Trinity Health IHA Medical Group Hematology Oncology - Brighton | Brighton | Michigan | United States | 48114 |
| 51 | Saint Joseph Mercy Canton | Canton | Michigan | United States | 48188 |
| 52 | Trinity Health IHA Medical Group Hematology Oncology - Canton | Canton | Michigan | United States | 48188 |
| 53 | Saint Joseph Mercy Chelsea | Chelsea | Michigan | United States | 48118 |
| 54 | Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital | Chelsea | Michigan | United States | 48118 |
| 55 | GenesisCare USA - Clarkston | Clarkston | Michigan | United States | 48346 |
| 56 | GenesisCare USA - Farmington Hills | Farmington Hills | Michigan | United States | 48334 |
| 57 | Mercy Health Saint Mary's | Grand Rapids | Michigan | United States | 49503 |
| 58 | Bronson Methodist Hospital | Kalamazoo | Michigan | United States | 49007 |
| 59 | West Michigan Cancer Center | Kalamazoo | Michigan | United States | 49007 |
| 60 | Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan | United States | 48154 |
| 61 | GenesisCare USA - Macomb | Macomb | Michigan | United States | 48044 |
| 62 | GenesisCare USA - Madison Heights | Madison Heights | Michigan | United States | 48071 |
| 63 | Ascension Saint Mary's Hospital | Saginaw | Michigan | United States | 48601 |
| 64 | Ascension Saint Joseph Hospital | Tawas City | Michigan | United States | 48764 |
| 65 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
| 66 | GenesisCare USA - Troy | Troy | Michigan | United States | 48098 |
| 67 | Metro Health Hospital | Wyoming | Michigan | United States | 49519 |
| 68 | Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus | Ypsilanti | Michigan | United States | 48197 |
| 69 | Miller-Dwan Hospital | Duluth | Minnesota | United States | 55805 |
| 70 | Regions Hospital | Saint Paul | Minnesota | United States | 55101 |
| 71 | Saint Francis Medical Center | Cape Girardeau | Missouri | United States | 63703 |
| 72 | University of Missouri - Ellis Fischel | Columbia | Missouri | United States | 65212 |
| 73 | University of Kansas Cancer Center - North | Kansas City | Missouri | United States | 64154 |
| 74 | University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | United States | 64064 |
| 75 | University of Kansas Cancer Center at North Kansas City Hospital | North Kansas City | Missouri | United States | 64116 |
| 76 | Billings Clinic Cancer Center | Billings | Montana | United States | 59101 |
| 77 | Saint James Community Hospital and Cancer Treatment Center | Butte | Montana | United States | 59701 |
| 78 | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana | United States | 59405 |
| 79 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 80 | Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | United States | 07920 |
| 81 | Cooper Hospital University Medical Center | Camden | New Jersey | United States | 08103 |
| 82 | Saint Barnabas Medical Center | Livingston | New Jersey | United States | 07039 |
| 83 | Memorial Sloan Kettering Monmouth | Middletown | New Jersey | United States | 07748 |
| 84 | Memorial Sloan Kettering Bergen | Montvale | New Jersey | United States | 07645 |
| 85 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
| 86 | Robert Wood Johnson University Hospital Somerset | Somerville | New Jersey | United States | 08876 |
| 87 | MD Anderson Cancer Center at Cooper-Voorhees | Voorhees | New Jersey | United States | 08043 |
| 88 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87102 |
| 89 | Memorial Sloan Kettering Commack | Commack | New York | United States | 11725 |
| 90 | Noyes Memorial Hospital/Myers Cancer Center | Dansville | New York | United States | 14437 |
| 91 | Arnot Ogden Medical Center/Falck Cancer Center | Elmira | New York | United States | 14905 |
| 92 | Memorial Sloan Kettering Westchester | Harrison | New York | United States | 10604 |
| 93 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 94 | Highland Hospital | Rochester | New York | United States | 14620 |
| 95 | University of Rochester | Rochester | New York | United States | 14642 |
| 96 | Stony Brook University Medical Center | Stony Brook | New York | United States | 11794 |
| 97 | Memorial Sloan Kettering Nassau | Uniondale | New York | United States | 11553 |
| 98 | Sanford Broadway Medical Center | Fargo | North Dakota | United States | 58122 |
| 99 | Sanford Roger Maris Cancer Center | Fargo | North Dakota | United States | 58122 |
| 100 | Altru Cancer Center | Grand Forks | North Dakota | United States | 58201 |
| 101 | Summa Health System - Akron Campus | Akron | Ohio | United States | 44304 |
| 102 | Summa Health System - Barberton Campus | Barberton | Ohio | United States | 44203 |
| 103 | UHHS-Chagrin Highlands Medical Center | Beachwood | Ohio | United States | 44122 |
| 104 | University of Cincinnati Cancer Center-UC Medical Center | Cincinnati | Ohio | United States | 45219 |
| 105 | Case Western Reserve University | Cleveland | Ohio | United States | 44106 |
| 106 | Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | United States | 44111 |
| 107 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 108 | Cleveland Clinic Cancer Center Mansfield | Mansfield | Ohio | United States | 44906 |
| 109 | Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | United States | 44124 |
| 110 | Summa Health Medina Medical Center | Medina | Ohio | United States | 44256 |
| 111 | UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio | United States | 44060 |
| 112 | UH Seidman Cancer Center at Southwest General Hospital | Middleburg Heights | Ohio | United States | 44130 |
| 113 | University Hospitals Parma Medical Center | Parma | Ohio | United States | 44129 |
| 114 | University Hospitals Portage Medical Center | Ravenna | Ohio | United States | 44266 |
| 115 | North Coast Cancer Care | Sandusky | Ohio | United States | 44870 |
| 116 | Cleveland Clinic Cancer Center Strongsville | Strongsville | Ohio | United States | 44136 |
| 117 | South Pointe Hospital | Warrensville Heights | Ohio | United States | 44122 |
| 118 | University of Cincinnati Cancer Center-West Chester | West Chester | Ohio | United States | 45069 |
| 119 | Cleveland Clinic Wooster Family Health and Surgery Center | Wooster | Ohio | United States | 44691 |
| 120 | Legacy Mount Hood Medical Center | Gresham | Oregon | United States | 97030 |
| 121 | Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon | United States | 97210 |
| 122 | Legacy Meridian Park Hospital | Tualatin | Oregon | United States | 97062 |
| 123 | Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania | United States | 19317 |
| 124 | Saint Vincent Hospital | Erie | Pennsylvania | United States | 16544 |
| 125 | Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | United States | 17033-0850 |
| 126 | Jefferson Hospital | Jefferson Hills | Pennsylvania | United States | 15025 |
| 127 | Forbes Hospital | Monroeville | Pennsylvania | United States | 15146 |
| 128 | Allegheny Valley Hospital | Natrona Heights | Pennsylvania | United States | 15065 |
| 129 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 130 | Jefferson Torresdale Hospital | Philadelphia | Pennsylvania | United States | 19114 |
| 131 | Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
| 132 | West Penn Hospital | Pittsburgh | Pennsylvania | United States | 15224 |
| 133 | Reading Hospital | West Reading | Pennsylvania | United States | 19611 |
| 134 | Wexford Health and Wellness Pavilion | Wexford | Pennsylvania | United States | 15090 |
| 135 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 136 | Self Regional Healthcare | Greenwood | South Carolina | United States | 29646 |
| 137 | Carolina Regional Cancer Center | Myrtle Beach | South Carolina | United States | 29577 |
| 138 | Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | United States | 57104 |
| 139 | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | United States | 57117-5134 |
| 140 | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | United States | 75390 |
| 141 | Central Vermont Medical Center/National Life Cancer Treatment | Berlin | Vermont | United States | 05602 |
| 142 | University of Vermont Medical Center | Burlington | Vermont | United States | 05401 |
| 143 | Norris Cotton Cancer Center-North | Saint Johnsbury | Vermont | United States | 05819 |
| 144 | Legacy Cancer Institute Medical Oncology and Day Treatment | Vancouver | Washington | United States | 98684 |
| 145 | Legacy Salmon Creek Hospital | Vancouver | Washington | United States | 98686 |
| 146 | Langlade Hospital and Cancer Center | Antigo | Wisconsin | United States | 54409 |
| 147 | ThedaCare Regional Cancer Center | Appleton | Wisconsin | United States | 54911 |
| 148 | Northwest Wisconsin Cancer Center | Ashland | Wisconsin | United States | 54806 |
| 149 | Aurora Cancer Care-Southern Lakes VLCC | Burlington | Wisconsin | United States | 53105 |
| 150 | Aurora Health Care Germantown Health Center | Germantown | Wisconsin | United States | 53022 |
| 151 | Aurora Cancer Care-Grafton | Grafton | Wisconsin | United States | 53024 |
| 152 | Bellin Memorial Hospital | Green Bay | Wisconsin | United States | 54301 |
| 153 | Aurora BayCare Medical Center | Green Bay | Wisconsin | United States | 54311 |
| 154 | Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin | United States | 53142 |
| 155 | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | United States | 53792 |
| 156 | Aurora Bay Area Medical Group-Marinette | Marinette | Wisconsin | United States | 54143 |
| 157 | Aurora Cancer Care-Milwaukee | Milwaukee | Wisconsin | United States | 53209 |
| 158 | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
| 159 | Aurora Sinai Medical Center | Milwaukee | Wisconsin | United States | 53233 |
| 160 | Zablocki Veterans Administration Medical Center | Milwaukee | Wisconsin | United States | 53295 |
| 161 | ProHealth D N Greenwald Center | Mukwonago | Wisconsin | United States | 53149 |
| 162 | ProHealth Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin | United States | 53066 |
| 163 | Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | United States | 54904 |
| 164 | Aurora Cancer Care-Racine | Racine | Wisconsin | United States | 53406 |
| 165 | Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin | United States | 53081 |
| 166 | Aurora Medical Center in Summit | Summit | Wisconsin | United States | 53066 |
| 167 | Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin | United States | 54241 |
| 168 | UW Cancer Center at ProHealth Care | Waukesha | Wisconsin | United States | 53188 |
| 169 | Aspirus Regional Cancer Center | Wausau | Wisconsin | United States | 54401 |
| 170 | Aurora Cancer Care-Milwaukee West | Wauwatosa | Wisconsin | United States | 53226 |
| 171 | Aurora West Allis Medical Center | West Allis | Wisconsin | United States | 53227 |
| 172 | Aspirus Cancer Care - Wisconsin Rapids | Wisconsin Rapids | Wisconsin | United States | 54494 |
| 173 | University Health Network-Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
Sponsors and Collaborators
- NRG Oncology
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Neil B Desai, MD, NRG Oncology
- Principal Investigator: Alejandro Berlin, MD, NRG Oncology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NRG-GU010
- NCI-2021-08760
- NRG-GU010
- NRG-GU010
- U10CA180868