Prostate Cancer

EA8191 / INDICATE



Treating Prostate Cancer That Has Come Back after Surgery with Apalutamide and Targeted Radiation Based on PET Imaging

STATUS: Active


This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen [PSA] after surgical removal of the prostate cancer). A second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced therapy (apalutamide in combination with abiraterone + prednisone) is tested. Diagnostic procedures, such as PET, may help doctors look for cancer that has spread to the pelvis. Androgens are hormones that may cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.
  • STEP 0: REGISTRATION ELIGIBILITY CRITERIA

  • Patient must be male and >= 18 years of age.

  • Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma

  • Patient must have biochemical recurrence (BCR) after RP, defined as follows: * If time to BCR, defined as time to first detectable PSA ( > lower limit of normal for assay used) after RP, is < 12 months, a minimum PSA level of >= 0.2 ng/mL and a confirmatory reading of >= 0.2 ng/mL is required, per the American Urological Association (AUA) definition (Note: patients with a persistent PSA reading of at least 0.2 ng/mL are eligible) * If time to BCR, defined as time to first detectable PSA (> lower limit of normal for assay used) after RP, is >= 12 months, a minimum absolute PSA of 0.5 ng/mL is required * If the patient has a detectable PSA (> lower limit of normal for assay used) at any time after RP AND has an eligible baseline SOC PET (PET1) with at least one positive lesion in any location, then there is no minimum PSA requirement

  • Patients must have no definite evidence for extrapelvic metastatic disease by conventional imaging modalities (CIM) (CT abdomen/pelvis or MRI abdomen/pelvis AND bone scintigraphy, or equivalent), within 26 weeks prior to Step 0 registration. If a patient only has a study-eligible PET/CT or PET/MR (i.e., PET done without prior CIM): if the PET is negative for extrapelvic lesions, then baseline CIM is NOT required. If the PET positive for extrapelvic lesions, then patient should have a baseline CT/MRI for soft tissue lesions and/or a bone scan for osseous lesions * Study eligible = PET using FDA-approved radiotracer and performed within 16 weeks prior to study registration

  • Extra-pelvic metastases is defined as any osseous metastases and/or any extrapelvic soft tissue, lymph nodes and organ metastases; extra-pelvic is defined as superior to common iliac bifurcation, outside of standard prostate bed + whole pelvis nodal RT fields. Baseline PET/CT or PET/MR scan (PET1) is eligible for this study if the SOC PET scan is completed with an FDA approved radiotracer for prostate cancer after Step 0 registration and prior to Step 1 randomization OR up to 16 weeks prior to Step 0 registration

  • Patient must be a candidate for SOC post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (ADT)

  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible

  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2

  • Patient must not have started ADT for biochemical recurrence prior to baseline PET (PET1) imaging. A short course of low-dose anti-androgen such as bicalutamide, given after baseline study PET/CT but prior to study registration, is permitted as a brief temporizing measure in advance of starting protocol-approved SOC ADT.

  • Patient must not be enrolled in another therapeutic clinical trial

  • Patient must be able to lie flat and still for approximately 20-30 minutes or otherwise tolerate a PET scan and radiation treatment planning and delivery

  • Patients undergoing a PET/MR must meet local institutional safety guidelines for MRI

  • Patient must not have history of seizures or known condition that may cause predisposal to seizures (e.g., stroke or head trauma resulting in loss of consciousness) within 1 year prior to registration

  • Patient must not have history of inflammatory bowel disease or any gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy

  • Hemoglobin (Hgb) >= 9.0 g/dL (independent of transfusion and/or growth factors within 3 months prior to Step 0 registration) (obtained within 8 weeks prior to Step 0 registration)

  • Leukocytes >= 3,000/mcL (obtained within 8 weeks prior to Step 0 registration)

  • Absolute neutrophil count >= 1,500/mcL (obtained within 8 weeks prior to Step 0 registration)

  • Platelets >= 100,000/mcL (obtained within 8 weeks prior to Step 0 registration)

  • Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (patients with Gilbertโ€™s syndrome, if total bilirubin is > 1.5 x ULN, must have a direct bilirubin of < 1.5 x ULN to be eligible) (obtained within 8 weeks prior to Step 0 registration)

  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained within 8 weeks prior to Step 0 registration)

  • Creatine < 1.5 x instituional ULN (or measured creatinine clearance > 30 mL/min)

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

  • 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. To be eligible for this trial, patients should be class I or II (by patient symptoms) or A or B (by objective assessment)

  • Patient must not have completed a course of prior pelvic radiation therapy for any reason

  • Patient must agree not to father children while on study

  • Patient must be English or Spanish speaking to be eligible for the QOL component of the study * NOTE: Sites cannot translate the associated QOL forms

  • STEP 1: RANDOMIZATION ELIGIBILITY CRITERIA

  • Patient must have completed a baseline SOC PET/CT or PET/MR (PET1 scan) using FDA approved radiotracer with results of extra-pelvic metastases involvement known (positive or negative). The PET1 must have been completed after Step 0 registration and prior to Step 1 randomization OR up to 12 weeks prior to Step 0 registration

  • For patients with negative extra-pelvic metastases, PET-imaging status of intra-pelvic nodes must be known (positive or negative)

  • For patients with positive extra-pelvic metastases (defined as any PET positive lesions outside of standard salvage RT fields [prostate bed +/- typical whole pelvis]), the number of extra-pelvic lesions must be known (1 - 5 or > 5 extra-pelvic lesions)

United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Oncology and Hematology LLC
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Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Women's Cancer Care
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Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Associates in Radiation Medicine
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Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Oncology Centre
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Email: AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
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Email: AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
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Email: AKPAMC.OncologyResearchSupport@providence.org

AR
Ft. Smith
Mercy Hospital Fort Smith
Contact: Site Public Contact

CA
Burbank
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Contact: Site Public Contact
Email: Najee.Boucher@providence.org

Duarte
City of Hope Comprehensive Cancer Center
Contact: Scott M Glaser
Email: sglaser@coh.org

La Jolla
UC San Diego Moores Cancer Center
Contact: Site Public Contact
Email: cancercto@ucsd.edu

Los Angeles
Los Angeles County-USC Medical Center
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UCLA / Jonsson Comprehensive Cancer Center
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USC / Norris Comprehensive Cancer Center
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DC
Washington
Sibley Memorial Hospital
Contact: Site Public Contact
Email: jquiver1@jhmi.edu

ID
Boise
Saint Alphonsus Cancer Care Center-Boise
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Boise
Contact: Site Public Contact
Email: eslinget@slhs.org

Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
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Email: stephanie.couch@stjoeshealth.org

Coeur D'Alene
Kootenai Health - Coeur d'Alene
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Email: mccinfo@mtcancer.org

Fruitland
Saint Luke's Cancer Institute - Fruitland
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Email: eslinget@slhs.org

Meridian
Idaho Urologic Institute-Meridian
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Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Meridian
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Email: eslinget@slhs.org

Nampa
Saint Alphonsus Cancer Care Center-Nampa
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Email: mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Nampa
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Email: eslinget@slhs.org

Post Falls
Kootenai Clinic Cancer Services - Post Falls
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Email: mccinfo@mtcancer.org

Twin Falls
Saint Luke's Cancer Institute - Twin Falls
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Email: eslinget@slhs.org

IL
Aurora
Rush - Copley Medical Center
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Email: Cancer.Research@rushcopley.com

Chicago
Northwestern University
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Email: cancer@northwestern.edu

University of Illinois
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Danville
Carle at The Riverfront
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Email: Research@Carle.com

DeKalb
Northwestern Medicine Cancer Center Kishwaukee
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Email: Donald.Smith3@nm.org

Effingham
Carle Physician Group-Effingham
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Email: Research@carle.com

Geneva
Northwestern Medicine Cancer Center Delnor
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Email: Donald.Smith3@nm.org

Mattoon
Carle Physician Group-Mattoon/Charleston
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Email: Research@carle.com

Maywood
Loyola University Medical Center
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Mount Vernon
Good Samaritan Regional Health Center
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Urbana
Carle Cancer Center
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Email: Research@carle.com

The Carle Foundation Hospital
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Email: Research@carle.com

Warrenville
Northwestern Medicine Cancer Center Warrenville
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

KS
Garden City
Central Care Cancer Center - Garden City
Contact: Site Public Contact
Email: aroland@kccop.org

Great Bend
Central Care Cancer Center - Great Bend
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Email: aroland@kccop.org

KY
Louisville
Jewish Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org

MD
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Contact: Site Public Contact
Email: jhcccro@jhmi.edu

University of Maryland/Greenebaum Cancer Center
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Bethesda
Suburban Hospital
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Email: bsquill1@jhmi.edu

Glen Burnie
UM Baltimore Washington Medical Center/Tate Cancer Center
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ME
Bath
MaineHealth Coastal Cancer Treatment Center
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Email: ctsucontact@westat.com

Biddeford
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
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Email: LLemire@mmc.org

Portland
Maine Medical Center-Bramhall Campus
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Sanford
MaineHealth Cancer Care Center of York County
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MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
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Email: LLemire@mmc.org

Scarborough
Maine Medical Center- Scarborough Campus
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Email: wrighd@mmc.org

South Portland
Maine Medical Partners - South Portland
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Email: ClinicalResearch@mmc.org

MN
Burnsville
Minnesota Oncology - Burnsville
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Email: mmcorc@healthpartners.com

Coon Rapids
Mercy Hospital
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Email: mmcorc@healthpartners.com

Edina
Fairview Southdale Hospital
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Email: mmcorc@healthpartners.com

Fridley
Unity Hospital
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Email: mmcorc@healthpartners.com

Maple Grove
Fairview Clinics and Surgery Center Maple Grove
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Email: mmcorc@healthpartners.com

Maplewood
Minnesota Oncology Hematology PA-Maplewood
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Email: mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
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Email: mmcorc@healthpartners.com

Minneapolis
Abbott-Northwestern Hospital
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Email: mmcorc@healthpartners.com

Health Partners Inc
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Email: mmcorc@healthpartners.com

Hennepin County Medical Center
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Email: mmcorc@healthpartners.com

Monticello
Monticello Cancer Center
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Email: mmcorc@healthpartners.com

Robbinsdale
North Memorial Medical Health Center
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Email: mmcorc@healthpartners.com

Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
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Email: mmcorc@healthpartners.com

Saint Paul
Regions Hospital
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Email: mmcorc@healthpartners.com

United Hospital
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Email: mmcorc@healthpartners.com

Shakopee
Saint Francis Regional Medical Center
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Email: mmcorc@healthpartners.com

Stillwater
Lakeview Hospital
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Email: mmcorc@healthpartners.com

Waconia
Ridgeview Medical Center
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Email: mmcorc@healthpartners.com

Willmar
Rice Memorial Hospital
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Email: mmcorc@healthpartners.com

Woodbury
Minnesota Oncology Hematology PA-Woodbury
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Email: mmcorc@healthpartners.com

MO
Bolivar
Central Care Cancer Center - Bolivar
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Email: aroland@kccop.org

Creve Coeur
Siteman Cancer Center at West County Hospital
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Email: info@siteman.wustl.edu

Joplin
Freeman Health System
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Email: LJCrockett@freemanhealth.com

Mercy Hospital Joplin
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Email: esmeralda.carrillo@mercy.net

Rolla
Delbert Day Cancer Institute at PCRMC
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Email: research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
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Saint Joseph
Heartland Regional Medical Center
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Email: linda.schumacher@mymlc.com

Saint Louis
Mercy Hospital Saint Louis
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Mercy Hospital South
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Email: janet.lesko@mercy.net

Siteman Cancer Center at Christian Hospital
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Email: info@siteman.wustl.edu

Siteman Cancer Center-South County
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Email: info@siteman.wustl.edu

Washington University School of Medicine
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Email: info@siteman.wustl.edu

Saint Peters
Siteman Cancer Center at Saint Peters Hospital
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Email: info@siteman.wustl.edu

Springfield
CoxHealth South Hospital
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Mercy Hospital Springfield
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MS
Jackson
University of Mississippi Medical Center
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MT
Billings
Billings Clinic Cancer Center
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Email: research@billingsclinic.org

Bozeman
Bozeman Deaconess Hospital
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Email: mccinfo@mtcancer.org

Great Falls
Benefis Healthcare- Sletten Cancer Institute
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Email: mccinfo@mtcancer.org

Great Falls Clinic
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Email: mccinfo@mtcancer.org

Kalispell
Kalispell Regional Medical Center
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Email: mccinfo@mtcancer.org

Missoula
Community Medical Hospital
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Email: mccinfo@mtcancer.org

Saint Patrick Hospital - Community Hospital
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Email: amy.hanneman@providence.org

NC
Kenansville
Vidant Oncology-Kenansville
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Email: research@ecuhealth.org

Kinston
Vidant Oncology-Kinston
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Email: research@ecuhealth.org

Richlands
Vidant Oncology-Richlands
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Email: research@ecuhealth.org

NJ
Camden
Cooper Hospital University Medical Center
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New Brunswick
Rutgers Cancer Institute of New Jersey
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Somerville
Robert Wood Johnson University Hospital Somerset
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Email: Siby.Varughese@rwjbh.org

Toms River
Community Medical Center
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Email: Lennette.Gonzales@rwjbh.org

Voorhees
MD Anderson Cancer Center at Cooper-Voorhees
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NY
Bronx
Montefiore Medical Center - Moses Campus
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Email: eskwak@montefiore.org

Montefiore Medical Center-Einstein Campus
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Email: eskwak@montefiore.org

Montefiore Medical Center-Weiler Hospital
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Email: eskwak@montefiore.org

New York
Mount Sinai Chelsea
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Email: CCTO@mssm.edu

Mount Sinai Hospital
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Email: CCTO@mssm.edu

Mount Sinai Union Square
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Email: CCTO@mssm.edu

Mount Sinai West
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Email: CCTO@mssm.edu

OH
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
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Email: cancer@uchealth.com

Columbus
Ohio State University Comprehensive Cancer Center
Contact: Site Public Contact
Email: Jamesline@osumc.edu

West Chester
University of Cincinnati Cancer Center-West Chester
Contact: Site Public Contact
Email: cancer@uchealth.com

OK
Oklahoma City
Mercy Hospital Oklahoma City
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University of Oklahoma Health Sciences Center
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Email: ou-clinical-trials@ouhsc.edu

OR
Bend
Saint Charles Health System
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Email: nosall@stcharleshealthcare.org

Clackamas
Clackamas Radiation Oncology Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Cancer Institute Clackamas Clinic
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Email: CanRsrchStudies@providence.org

Coos Bay
Bay Area Hospital
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Email: cherie.cox@bayareahospital.org

Gresham
Legacy Mount Hood Medical Center
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Newberg
Providence Newberg Medical Center
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Email: CanRsrchStudies@providence.org

Oregon City
Providence Willamette Falls Medical Center
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Email: CanRsrchStudies@providence.org

Portland
Legacy Good Samaritan Hospital and Medical Center
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Email: cancer@lhs.org

Oregon Health and Science University
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Email: trials@ohsu.edu

Providence Portland Medical Center
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Email: CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
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Email: CanRsrchStudies@providence.org

Tualatin
Legacy Meridian Park Hospital
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PA
Altoona
UPMC Altoona
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Email: ecog.rss@jimmy.harvard.edu

Beaver
UPMC-Heritage Valley Health System Beaver
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Email: haneydl@upmc.edu

Broomall
Crozer-Keystone Regional Cancer Center at Broomall
Contact: Site Public Contact
Email: Jolene.garney@crozer.org

Carlisle
Carlisle Regional Cancer Center
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Drexel Hill
Delaware County Memorial Hospital
Contact: Site Public Contact
Email: jolene.garney@crozer.org

East Norriton
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Erie
UPMC Hillman Cancer Center Erie
Contact: Site Public Contact
Email: haneydl@upmc.edu

Farrell
UPMC Cancer Center at UPMC Horizon
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Email: ecog.rss@jimmy.harvard.edu

Furlong
Fox Chase Cancer Center Buckingham
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Glen Mills
Crozer Regional Cancer Center at Brinton Lake
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Greensburg
UPMC Cancer Centers - Arnold Palmer Pavilion
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Harrisburg
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
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Email: klitchfield@PINNACLEHEALTH.org

Hershey
Penn State Milton S Hershey Medical Center
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Email: CTO@hmc.psu.edu

Johnstown
UPMC-Johnstown/John P. Murtha Regional Cancer Center
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Mechanicsburg
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
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Email: haneydl@upmc.edu

Monroeville
UPMC Cancer Center - Monroeville
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Email: ecog.rss@jimmy.harvard.edu

Moon Township
UPMC Hillman Cancer Center in Coraopolis
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Email: haneydl@upmc.edu

Natrona Heights
UPMC Cancer Center-Natrona Heights
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Philadelphia
Fox Chase Cancer Center
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Penn Presbyterian Medical Center
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Email: ecog.rss@jimmy.harvard.edu

Temple University Hospital
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Thomas Jefferson University Hospital
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Email: ONCTrialNow@jefferson.edu

University of Pennsylvania/Abramson Cancer Center
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Pittsburgh
UPMC-Magee Womens Hospital
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UPMC-Passavant Hospital
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UPMC-Saint Clair Hospital Cancer Center
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UPMC-Saint Margaret
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UPMC-Shadyside Hospital
Contact: Site Public Contact

University of Pittsburgh Cancer Institute (UPCI)
Contact: Site Public Contact

Seneca
UPMC Cancer Center at UPMC Northwest
Contact: Site Public Contact

Uniontown
UPMC Uniontown Hospital Radiation Oncology
Contact: Site Public Contact

Washington
UPMC Washington Hospital Radiation Oncology
Contact: Site Public Contact
Email: cancer@washingtonhospital.org

Williamsport
UPMC Susquehanna
Contact: Site Public Contact

York
UPMC Memorial
Contact: Site Public Contact

SC
Charleston
Medical University of South Carolina
Contact: Site Public Contact
Email: hcc-clinical-trials@musc.edu

SD
Sioux Falls
Sanford Cancer Center Oncology Clinic
Contact: Site Public Contact
Email: OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Contact: Site Public Contact
Email: OncologyClinicalTrialsSF@SanfordHealth.org

TX
Dallas
UT Southwestern Simmons Cancer Center - RedBird
Contact: Site Public Contact
Email: canceranswerline@utsouthwestern.edu

UT Southwestern/Simmons Cancer Center-Dallas
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

Fort Worth
UT Southwestern/Simmons Cancer Center-Fort Worth
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

Richardson
UT Southwestern Clinical Center at Richardson/Plano
Contact: Site Public Contact
Email: Suzanne.cole@utsouthwestern.edu

San Antonio
Audie L Murphy VA Hospital
Contact: Site Public Contact

University of Texas Health Science Center at San Antonio
Contact: Site Public Contact
Email: phoresearchoffice@uthscsa.edu

VA
Richmond
Virginia Commonwealth University/Massey Cancer Center
Contact: Site Public Contact
Email: CTOclinops@vcu.edu

WI
Antigo
Langlade Hospital and Cancer Center
Contact: Site Public Contact
Email: Juli.Alford@aspirus.org

Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Johnson Creek
UW Cancer Center Johnson Creek
Contact: Site Public Contact
Email: lynda.persico@uwmf.wisc.edu

Madison
University of Wisconsin Carbone Cancer Center
Contact: Site Public Contact

Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Minocqua
Marshfield Clinic-Minocqua Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

New Richmond
Cancer Center of Western Wisconsin
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Rice Lake
Marshfield Medical Center-Rice Lake
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Stevens Point
Ascension Saint Michael's Hospital
Contact: Site Public Contact
Email: Beth.Knetter@aspirus.org

Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wausau
Aspirus Regional Cancer Center
Contact: Site Public Contact

Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wisconsin Rapids
Aspirus Cancer Care - Wisconsin Rapids
Contact: Site Public Contact

WY
Sheridan
Welch Cancer Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

PRIMARY OBJECTIVES:
I. For patients without PET-evidence of extrapelvic metastases, to evaluate whether the addition of enhanced systemic therapy to standard of care (SOC) salvage radiation therapy (RT) could prolong progression-free survival (PFS).
II. For patients with PET-evidence of extrapelvic metastases, to evaluate whether the addition of metastasis-directed RT to enhanced systemic therapy and SOC salvage RT could prolong PFS.
III. To compare overall quality of life, measured by Functional Assessment of Cancer Therapy - Prostate (FACT-P) total score, at 6 months between the two sets of treatment arms (A with B and C with D). (QUALITY OF LIFE [QOL] OBJECTIVE)

SECONDARY OBJECTIVES:
I. To evaluate overall survival in each arm.
II. To evaluate event-free survival in each arm.
III. To evaluate time to prostate-specific antigen (PSA) progression in each arm.
IV. To assess the incidence of adverse events with the addition of enhanced systemic therapy in patients without PET-evidence of extrapelvic metastases.
V. To assess the incidence of adverse events with local ablative metastasis-directed RT for PET-positive metastatic disease in patients with PET-evidence of extrapelvic metastases.
VI. To estimate the detection rate of PET at the patient and regional level, and to evaluate its concordance with the follow-up Food and Drug Administration (FDA)-approved conventional imaging modalities (CIM) (as available) considered standard-of-care per institution, including computed tomography (CT), bone scintigraphy, magnetic resonance imaging (MRI) and PET imaging.
VII. To determine the distribution of PET-positive lesions among anatomic sites (prostate fossa, intrapelvic soft tissue/lymph node, extrapelvic soft tissue/lymph node, and bone metastases) in patients with post-radical prostatectomy (RP) biochemical recurrence (BCR), correlated with PSA (level, doubling time, velocity) and other relevant clinical parameters.
VIII. To compare the change in overall QOL, measured by FACT-P total score, from baseline to 6 months between the two sets of treatment arms (A with B and C with D). (QOL OBJECTIVE)
IX. To compare patient-reported fatigue (Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue scores) at 6 months between the two sets of treatment arms (A with B and C with D). (QOL OBJECTIVE)
X. To compare patient-reported overall QOL (FACT-P scores), fatigue (FACIT-Fatigue scores) and pain interference (patient reported outcomes measurement information system [PROMIS] Pain Interference Short Form 4a) between the two sets of treatment arms (A with B and C with D) at the time of disease progression. (QOL OBJECTIVE)

EXPLORATORY OBJECTIVES:
I.To determine the value of repeat PET (PET2) at time of second PSA progression, clinical concern for progression, or 12 months after completion of enhanced systemic therapy, whichever comes first to assess response to therapy (enhanced systemic therapy +/- focal RT and/or androgen deprivation therapy [ADT]) compared to available standard response assessments (PSA and conventional imaging modalities [CIM]).
II. To compare cognitive function, measured by FACT - cognitive function (Cog) peritoneal cancer index (PCI) and total scores, between the three treatment arms receiving enhanced systemic treatment with ADT and apalutamide (Arms B, C, and D) and antiandrogen therapy (ADT) alone (Arm A) at 6 and 12 month. (QOL OBJECTIVE)
III. To compare the change in cognitive function, measured by change in FACT-Cog PCI and total scores, from baseline to 6 and baseline to 12 months, between the three treatment arms receiving enhanced systemic treatment with ADT and apalutamide (Arms B, C, and D) and ADT alone (Arm A) at 6 and 12 months. (QOL OBJECTIVE)
IV. To characterize longitudinal change in cognitive function between baseline and 24 months in patients with prostate cancer receiving treatment for biochemical recurrence (BCR) and define clinical and disease related characteristics associated with greater cognitive change by the FACT-Cog PCI and total scores. (QOL OBJECTIVE)

OUTLINE: 

STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 intravenously (IV) undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2. 

STEP 1: Patients are randomized to 1 of 4 arms based on results of fluciclovine F18 PET/CT or PET/MR in Step 0.

ARM A (PET NEGATIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC external beam radiation therapy (EBRT) for 6 months. Patients also receive goserelin acetate subcutaneously (SC), leuprolide acetate intramuscularly (IM), triptorelin IM, relugolix orally (PO), or degarelix SC for 6 months starting up to 3 months prior to EBRT but no later than 7 days after start of EBRT. All treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.

ARM B (PET NEGATIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO once daily (QD) for 6 months in the absence of disease progression or unacceptable toxicity.

ARM C: (PET POSITIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD as in Arm B.

ARM D (PET POSITIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A and apalutamide PO QD as in Arm B. Patients also undergo stereotactic body radiation therapy (SBRT) or 3-dimensional (3D) conformal radiation therapy (CRT), intensity-modulated radiation therapy (IMRT) (including volume modulated arc therapy [VMAT]), and intensity-modulated proton therapy (IMPT) over 3-10 fractions in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for the first 2 years, every 6 months for years 3-5, and then annually for years 6-10.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


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