Antiandrogen Therapy and Radiation Therapy with or without Docetaxel in Treating Patients with Prostate Cancer That Has Been Removed by Surgery

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This clinical trial matches:
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Status: Active

Description

This randomized phase II / III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

Eligibility Criteria

Inclusion Criteria

  • Patients post-prostatectomy with baseline Gleason >= 7 (per prostatectomy pathology)
  • Baseline PSA nadir >= 0.2 ng/ml (post-operative value is never undetectable) obtained prior to step 1 registration
  • Baseline testosterone level obtained post prostatectomy prior to step 1 registration
  • Pathologically (histologically) proven diagnosis of adenocarcinoma of the prostate as confirmed at time of prostatectomy; prostatectomy must have been performed =< 365 days (1 year) prior to step 1 registration any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted; (please note: Prior ablative treatment for benign prostatic hypertrophy or focal high-intensity focused ultrasound therapy [HIFU] prior to prostatectomy is allowed)
  • Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on DECIPHER GRID platform * Please note: If a patient already has a Decipher risk score and meets all of the other eligibility criteria, the patient is eligible to be registered; however, the Decipher risk report will need to be submitted to GenomeDx for validation
  • Prior androgen deprivation (luteinizing hormone-releasing hormone [LHRH] agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to study enrollment and given for =< 90 days duration * For example: Patients on prior LHRH analogs (post-prostatectomy), the discontinuation date should be calculated based on the expected duration of the sustained release injection, not simply the injection date of the drug; for instance, if a 22.5 mg sustained release dose of leuprolide acetate is given (3 month duration), then the expected duration of such a dose would be 90 days after the injection date; for a 7.5 mg leuprolide (1 month duration), the discontinuation date would be 30 days after the injection date * Please note: Finasteride or dutasteride must be stopped before treatment but should not determine eligibility
  • Pathologically proven to be lymph node negative by pelvic lymphadenectomy (pN0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [pNx])
  • Any pT-stage based on American Joint Committee on Cancer 7th edition eligible; study entry will be based on the following diagnostic workup: * History/physical examination within 60 days prior to step 1 registration * Negative distant metastatic workup: ** A computed tomography (CT) scan of the abdomen and pelvis (with contrast [CT without contrast is permitted if the patient is not a candidate for contrast, i.e., renal function or allergy]) or magnetic resonance imaging (MRI) of the pelvis within 120 days prior to step 1 registration; (Please note: Lymph nodes will be considered negative (NO)if they are =< 1.5 cm short axis); ** Bone scan within 120 days prior to step 1 registration; (please note: a sodium fluoride [NaF] positron emission tomography [PET]/CT is an acceptable substitute and if the bone scan is suspicious, a plain x-ray, CT scan, NaF PET/CT and/or MRI must be obtained to rule out metastasis)
  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 90 days prior to step 1 registration
  • Platelets >= 100,000 cell/mm^3
  • Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is NOT allowed)
  • Absolute neutrophil count >= 1500 cells/mm^3
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 1.5 x the upper limit of normal
  • Total bilirubin (=< 1.5 mg/dl) normal unless history of Gilbert’s syndrome
  • The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration

Exclusion Criteria

  • Definitive clinical or radiologic evidence of metastatic disease
  • Prior invasive malignancy (except non-melanomatous skin cancer or other in-situ malignancies, or stage Ta bladder cancer) unless disease free for a minimum of 2 years
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if completed more than two years prior to step 1 registration; prior androgen deprivation is allowed
  • Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound [HIFU]) for prostate cancer is allowed; prior focal HIFU or treatment for benign prostatic hypertrophy is allowed
  • Prostatectomy performed greater than 365 days (1 year) prior to step 1 registration
  • Severe and/or active co-morbidity defined as follows: * History of inflammatory bowel disease * History of active hepatitis B or C; blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 15 days of step 1 registration or precluding study therapy at the time of step 1 registration * Uncontrolled severe illness or medical condition (including uncontrolled diabetes), which in the judgment of the treating physician would make the administration of chemotherapy inadvisable
  • Human immunodeficiency virus (HIV) positive with cluster of differentiation 4 (CD4) count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to step 1 registration; note also that HIV testing is not required for eligibility for this protocol

Locations & Contacts

Alaska

Fairbanks
Fairbanks Memorial Hospital
Status: Active
Contact: John A. Keech
Phone: 907-458-5380

Arizona

Tucson
The University of Arizona Medical Center-University Campus
Status: Active
Contact: Shona T. Dougherty
Phone: 520-626-9008
University of Arizona Cancer Center-Orange Grove Campus
Status: Active
Contact: Shona T. Dougherty
Phone: 520-694-8900

California

Antioch
Kaiser Permanente-Deer Valley Medical Center
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
Fremont
Kaiser Permanente-Fremont
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
Fresno
Fresno Cancer Center
Status: Active
Contact: Tatjana Kolevska
Phone: 412-339-5294 Email: Roster@nrgoncology.org
Kaiser Permanente-Fresno
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Contact: Brent Shane Rose
Phone: 858-822-5354 Email: cancercto@ucsd.edu
Modesto
Kaiser Permanente-Modesto
Status: Active
Contact: Tatjana Kolevska
Phone: 877-642-4691
Oakland
Kaiser Permanente Oakland-Broadway
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
Kaiser Permanente-Oakland
Status: Active
Contact: Tatjana Kolevska
Phone: 877-642-4691 Email: Kpoct@kp.org
Paradise
Feather River Cancer Center
Status: Active
Contact: Sam Mazj
Phone: 530-876-7995 Email: haleew@ah.org
Rancho Cordova
Kaiser Permanente-Rancho Cordova Cancer Center
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
Redwood City
Kaiser Permanente-Redwood City
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
Richmond
Kaiser Permanente-Richmond
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
Rohnert Park
Rohnert Park Cancer Center
Status: Active
Contact: Tatjana Kolevska
Phone: 707-584-2200
Roseville
Kaiser Permanente-Roseville
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
Sutter Cancer Centers Radiation Oncology Services-Roseville
Status: Active
Contact: Christopher Uwe Jones
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
The Permanente Medical Group-Roseville Radiation Oncology
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
Sacramento
Kaiser Permanente - Sacramento
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
Kaiser Permanente-South Sacramento
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
South Sacramento Cancer Center
Status: Active
Contact: Tatjana Kolevska
Phone: 916-683-9616
Sutter Medical Center Sacramento
Status: Active
Contact: Christopher Uwe Jones
Phone: 916-537-5237
San Diego
Naval Medical Center -San Diego
Status: Active
Contact: Harvey Bernard Wilds
Phone: 619-532-8712
San Francisco
Kaiser Permanente-San Francisco
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
San Jose
Kaiser Permanente-Santa Teresa-San Jose
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
San Leandro
Kaiser Permanente San Leandro
Status: Active
Contact: Tatjana Kolevska
Phone: 510-454-2724
San Rafael
Kaiser Permanente-San Rafael
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
Kaiser San Rafael-Gallinas
Status: Active
Contact: Tatjana Kolevska
Phone: 877-642-4691 Email: Kpoct@kp.org
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
Santa Rosa
Kaiser Permanente-Santa Rosa
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
South San Francisco
Kaiser Permanente Cancer Treatment Center
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
Kaiser Permanente-South San Francisco
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
Stockton
Kaiser Permanente-Stockton
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
Truckee
Gene Upshaw Memorial Tahoe Forest Cancer Center
Status: Active
Contact: Richard K. Valicenti
Phone: 530-582-6450
Vacaville
Kaiser Permanente Medical Center-Vacaville
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
Vallejo
Kaiser Permanente-Vallejo
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400
Sutter Solano Medical Center / Cancer Center
Status: Active
Contact: Christopher Uwe Jones
Phone: 916-537-5237
Walnut Creek
Kaiser Permanente-Walnut Creek
Status: Active
Contact: Tatjana Kolevska
Phone: 510-891-3400

Colorado

Aurora
University of Colorado Hospital
Status: Active
Contact: Elizabeth Riley Kessler
Phone: 720-848-0650
Fort Collins
Poudre Valley Hospital
Status: Active
Contact: Elizabeth Riley Kessler
Phone: 720-848-0650

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: Active
Contact: Gregory Andrew Masters
Phone: 302-733-6227
Helen F Graham Cancer Center
Status: Active
Contact: Gregory Andrew Masters
Phone: 302-733-6227
Rehoboth Beach
Beebe Health Campus
Status: Active
Contact: Gregory Andrew Masters
Phone: 302-733-6227

Florida

Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Status: Active
Contact: Matthew Charles Abramowitz
Phone: 305-243-2647
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: Active
Contact: Matthew Charles Abramowitz
Phone: 305-243-2647
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Contact: Matthew Charles Abramowitz
Phone: 305-243-2647

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: Active
Contact: Ashesh B. Jani
Phone: 404-489-9164
Emory University Hospital / Winship Cancer Institute
Status: Active
Contact: Ashesh B. Jani
Phone: 404-489-9164
Emory University Hospital Midtown
Status: Active
Contact: Ashesh B. Jani
Phone: 404-489-9164
Grady Health System
Status: Active
Contact: Ashesh B. Jani
Phone: 404-489-9164
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: Active
Contact: Howard A. Zaren
Phone: 912-819-5704

Illinois

Chicago
Northwestern University
Status: Active
Contact: Sean Sachdev
Phone: 312-695-1301 Email: cancer@northwestern.edu
Rush University Medical Center
Status: Active
Contact: Dian Wang
Phone: 312-942-5498 Email: clinical_trials@rush.edu
Decatur
Decatur Memorial Hospital
Status: Active
Contact: Bryan A. Faller
Phone: 217-876-4740 Email: rhamrick@dmhhs.org
Effingham
Crossroads Cancer Center
Status: Active
Contact: Bryan A. Faller
Phone: 217-876-4740 Email: rhamrick@dmhhs.org
Elmhurst
Elmhurst Memorial Hospital
Status: Active
Contact: Brian Christopher Myre
Phone: 630-646-6075
Maywood
Loyola University Medical Center
Status: Active
Contact: Abhishek Ashok Solanki
Phone: 708-226-4357
Naperville
Edward Hospital / Cancer Center
Status: Active
Contact: Brian Christopher Myre
Phone: 630-646-6075
Peoria
OSF Saint Francis Medical Center
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Plainfield
Edward Hospital / Cancer Center?Plainfield
Status: Active
Contact: Brian Christopher Myre
Phone: 630-646-6075

Indiana

Fort Wayne
Parkview Hospital Randallia
Status: Active
Contact: Zhentao Zhang
Phone: 260-373-8888 Email: parkviewresearch@parkview.com
Goshen
Goshen Center for Cancer Care
Status: Active
Contact: Sachin Agarwal
Phone: 574-364-2973 Email: cccois@goshenhealth.com
Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Active
Contact: Nabil Adra
Phone: 412-339-5294 Email: Roster@nrgoncology.org
Richmond
Reid Health
Status: Active
Contact: Howard M. Gross
Phone: 937-775-1350 Email: som_dcop@wright.edu

Iowa

Ames
McFarland Clinic PC - Ames
Status: Active
Contact: Joseph James Merchant
Phone: 515-239-2621

Kansas

Kansas City
University of Kansas Cancer Center
Status: Active
Contact: Xinglei Shen
Phone: 913-945-7552 Email: ctnursenav@kumc.edu
Olathe
Olathe Medical Center
Status: Active
Contact: Xinglei Shen
Phone: 913-791-3500 Email: Jeni.wakefield@olathehealth.org
Overland Park
University of Kansas Cancer Center-Overland Park
Status: Active
Contact: Xinglei Shen
Phone: 913-945-7552 Email: ctnursenav@kumc.edu
Topeka
Cotton O'Neil Cancer Center / Stormont Vail Health
Status: Active
Contact: Ajay Tejwani
Phone: 888-823-5923 Email: ctsucontact@westat.com
Wichita
Via Christi Regional Medical Center
Status: Active
Contact: Pavan S. Reddy
Phone: 316-268-5374

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: Active
Contact: Troy Gene Scroggins
Phone: 504-842-3708

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: Active
Contact: Mark V. Mishra
Phone: 800-888-8823
Columbia
Central Maryland Radiation Oncology in Howard County
Status: Active
Contact: Mark V. Mishra
Phone: 443-546-1300
Glen Burnie
Tate Cancer Center
Status: Active
Contact: Mark V. Mishra
Phone: 410-553-8100
Salisbury
Peninsula Regional Medical Center
Status: Active
Contact: John Romeo Mansueti
Phone: 866-922-6237

Massachusetts

Boston
Boston Medical Center
Status: Active
Contact: Gretchen A. Gignac
Phone: 617-638-8265
Burlington
Lahey Hospital and Medical Center
Status: Active
Contact: Krishna Soujanya Gunturu
Phone: 781-744-8027

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: Active
Contact: Samir Narayan
Phone: 208-367-7954
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Daniel Eidelberg Spratt
Phone: 800-865-1125
Brownstown
Henry Ford Cancer Institute¿Downriver
Status: Active
Contact: Eleanor M. Walker
Phone: 313-916-1784
Clarkston
21st Century Oncology MHP - Clarkston
Status: Active
Contact: Frank A. Vicini
Phone: 248-338-0663
McLaren Cancer Institute-Clarkston
Status: Active
Contact: Kiran Devisetty
Phone: 412-339-5294 Email: Roster@nrgoncology.org
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: Active
Contact: Eleanor M. Walker
Phone: 313-916-1784
Detroit
Henry Ford Hospital
Status: Active
Contact: Eleanor M. Walker
Phone: 313-916-1784
Wayne State University / Karmanos Cancer Institute
Status: Active
Contact: Kiran Devisetty
Phone: 313-576-9363
Farmington Hills
21st Century Oncology MHP - Farmington
Status: Active
Contact: Frank A. Vicini
Phone: 248-338-0663
Weisberg Cancer Treatment Center
Status: Active
Contact: Kiran Devisetty
Phone: 313-576-9363
Flint
McLaren Cancer Institute-Flint
Status: Active
Contact: Kiran Devisetty
Phone: 810-342-4071
Kalamazoo
West Michigan Cancer Center
Status: Active
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Lansing
McLaren-Greater Lansing
Status: Active
Contact: Kiran Devisetty
Phone: 517-334-2765
Sparrow Hospital
Status: Active
Contact: Samir Narayan
Phone: 734-712-3671
Lapeer
McLaren Cancer Institute-Lapeer Region
Status: Active
Contact: Kiran Devisetty
Phone: 412-339-5294 Email: Roster@nrgoncology.org
Livonia
Saint Mary Mercy Hospital
Status: Active
Contact: Samir Narayan
Phone: 208-367-7954
Mount Clemens
McLaren Cancer Institute-Macomb
Status: Active
Contact: Kiran Devisetty
Phone: 586-493-3426
Mount Pleasant
McLaren Cancer Institute-Central Michigan
Status: Active
Contact: Kiran Devisetty
Phone: 412-339-5294 Email: Roster@nrgoncology.org
Petoskey
McLaren Cancer Institute-Northern Michigan
Status: Active
Contact: Kiran Devisetty
Phone: 800-248-6777
Pontiac
Saint Joseph Mercy Oakland
Status: Active
Contact: Samir Narayan
Phone: 734-712-3671
Port Huron
McLaren-Port Huron
Status: Active
Contact: Kiran Devisetty
Phone: 412-339-5294 Email: Roster@nrgoncology.org
Saginaw
Saint Mary's of Michigan
Status: Active
Contact: Samir Narayan
Phone: 412-339-5294 Email: Roster@nrgoncology.org
Troy
21st Century Oncology MHP - Troy
Status: Active
Contact: Frank A. Vicini
Phone: 412-339-5294 Email: Roster@nrgoncology.org
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: Active
Contact: Eleanor M. Walker
Phone: 313-916-1784

Minnesota

Bemidji
Sanford Clinic North-Bemidgi
Status: Active
Contact: Preston D. Steen
Phone: 712-252-0088
Mankato
Mayo Clinic Health Systems-Mankato
Status: Active
Contact: Bradley J. Stish
Phone: 855-776-0015
Saint Cloud
Coborn Cancer Center at Saint Cloud Hospital
Status: Active
Contact: Donald James Jurgens
Phone: 877-229-4907 Email: coborncancercenter@centracare.com
Saint Paul
Regions Hospital
Status: Active
Contact: Paul W. Sperduto
Phone: 952-993-1517 Email: mmcorc@healthpartners.com

Missouri

Kansas City
The University of Kansas Cancer Center-North
Status: Active
Contact: Xinglei Shen
Phone: 913-945-7552 Email: ctnursenav@kumc.edu
The University of Kansas Cancer Center-South
Status: Active
Contact: Xinglei Shen
Phone: 913-945-7552 Email: ctnursenav@kumc.edu
Lee's Summit
The University of Kansas Cancer Center-Lee's Summit
Status: Active
Contact: Xinglei Shen
Phone: 913-945-7552 Email: ctnursenav@kumc.edu
Saint Joseph
Heartland Regional Medical Center
Status: Active
Contact: Jay W. Carlson
Phone: 913-948-5588 Email: aroland@kccop.org
Saint Louis
Siteman Cancer Center-South County
Status: Active
Contact: Jeff M. Michalski
Phone: 800-600-3606 Email: info@siteman.wustl.edu
Washington University School of Medicine
Status: Active
Contact: Jeff M. Michalski
Phone: 800-600-3606 Email: info@siteman.wustl.edu
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: Active
Contact: Jeff M. Michalski
Phone: 800-600-3606 Email: info@siteman.wustl.edu

Montana

Billings
Billings Clinic Cancer Center
Status: Active
Contact: Benjamin T. Marchello
Phone: 406-969-6060 Email: mccinfo@mtcancer.org
Bozeman
Bozeman Deaconess Hospital
Status: Active
Contact: Benjamin T. Marchello
Phone: 406-969-6060 Email: mccinfo@mtcancer.org
Kalispell
Kalispell Regional Medical Center
Status: Active
Contact: Benjamin T. Marchello
Phone: 406-969-6060 Email: mccinfo@mtcancer.org

Nebraska

Omaha
Nebraska Methodist Hospital
Status: Active
Contact: Ralph J. Hauke
Phone: 402-354-5144

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Active
Contact: Alan Charles Hartford
Phone: 800-639-6918 Email: cancer.research.nurse@dartmouth.edu

New York

Brooklyn
New York-Presbyterian / Brooklyn Methodist Hospital
Status: Active
Contact: Hani L. Ashamalla
Phone: 718-780-3677 Email: Adg9003@nyp.org
Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Gurkamal S. Chatta
Phone: 877-275-7724
Rochester
Highland Hospital
Status: Temporarily closed to accrual
Contact: Yuhchyau Chen
Phone: 585-341-8113
University of Rochester
Status: Active
Contact: Yuhchyau Chen
Phone: 585-341-8113
Stony Brook
Stony Brook University Medical Center
Status: Active
Contact: Craig Eli Grossman
Phone: 800-862-2215
White Plains
Dickstein Cancer Treatment Center
Status: Active
Contact: Jeffrey M. Vainshtein
Phone: 404-778-1868

North Carolina

Durham
Duke University Medical Center
Status: Active
Contact: William Robert Lee
Phone: 888-275-3853
Greensboro
Cone Health Cancer Center
Status: Active
Contact: Vinay K. Gudena
Phone: 336-832-0821
Hendersonville
Margaret R Pardee Memorial Hospital
Status: Active
Contact: James Earl Radford
Phone: 828-696-4716 Email: karen.morris@unchealth.unc.edu

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: Active
Contact: Preston D. Steen
Phone: 712-252-0088
Fargo
Roger Maris Cancer Center
Status: Active
Contact: Preston D. Steen
Phone: 712-252-0088

Ohio

Beachwood
UHHS-Chagrin Highlands Medical Center
Status: Active
Contact: Christopher James Hoimes
Phone: 800-641-2422
Chardon
Geauga Hospital
Status: Active
Contact: Christopher James Hoimes
Phone: 800-641-2422
Cleveland
Case Western Reserve University
Status: Active
Contact: Christopher James Hoimes
Phone: 800-641-2422
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Dayssy Alexandra Diaz Pardo
Phone: 800-293-5066 Email: Jamesline@osumc.edu
Elyria
Mercy Cancer Center-Elyria
Status: Temporarily closed to accrual
Contact: Christopher James Hoimes
Phone: 800-641-2422 Email: CTUReferral@UHhospitals.org
Franklin
Atrium Medical Center-Middletown Regional Hospital
Status: Active
Contact: Howard M. Gross
Phone: 937-775-1350 Email: som_dcop@wright.edu
Mentor
Lake University Ireland Cancer Center
Status: Active
Contact: Christopher James Hoimes
Phone: 800-641-2422
Middleburg Heights
Southwest General Health Center Ireland Cancer Center
Status: Active
Contact: Christopher James Hoimes
Phone: 800-641-2422
Parma
University Hospitals Parma Medical Center
Status: Active
Contact: Christopher James Hoimes
Phone: 800-641-2422
Sandusky
Ireland Cancer Center at Firelands Regional Medical Center
Status: Active
Contact: Christopher James Hoimes
Phone: 800-641-2422
Sylvania
Flower Hospital
Status: Active
Contact: Abhijit B. Saste
Phone: 419-824-1842
Westlake
UHHS-Westlake Medical Center
Status: Active
Contact: Christopher James Hoimes
Phone: 800-641-2422

Oklahoma

Lawton
Cancer Centers of Southwest Oklahoma Research
Status: Active
Contact: J. Spencer Thompson
Phone: 877-231-4440
Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: J. Spencer Thompson
Phone: 405-271-8777 Email: ou-clinical-trials@ouhsc.edu

Oregon

Clackamas
Clackamas Radiation Oncology Center
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org
Portland
Providence Portland Medical Center
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org

Pennsylvania

Abington
Abington Memorial Hospital
Status: Active
Contact: Wayne H. Pinover
Phone: 215-481-2402
Broomall
Crozer-Keystone Regional Cancer Center at Broomall
Status: Active
Contact: Rachelle M. Lanciano
Phone: 610-284-8237 Email: Jolene.garney@crozer.org
Chadds Ford
Christiana Care Health System-Concord Health Center
Status: Active
Contact: Gregory Andrew Masters
Phone: 302-733-6227
Danville
Geisinger Medical Center
Status: Active
Contact: Raghava Reddy Levaka Veera
Phone: 570-271-5251 Email: HemonCCTrials@geisinger.edu
Dunmore
Northeast Radiation Oncology Center
Status: Active
Contact: Mark David Hurwitz
Phone: 877-726-5130
Glen Mills
Crozer Regional Cancer Center at Brinton Lake
Status: Active
Contact: Rachelle M. Lanciano
Phone: 610-284-8237
Langhorne
Saint Mary Medical and Regional Cancer Center
Status: Active
Contact: Robert E. Reilly
Phone: 215-710-4585
Lewistown
Lewistown Hospital
Status: Active
Contact: Raghava Reddy Levaka Veera
Phone: 717-242-7703
Philadelphia
Fox Chase Cancer Center
Status: Active
Contact: Mark L. Sobczak
Phone: 215-728-4790
NRG Oncology
Status: Active
Contact: Mark David Hurwitz
Phone: 215-955-6084
Temple University Hospital
Status: Active
Contact: Mark L. Sobczak
Phone: 215-728-2983
Thomas Jefferson University Hospital
Status: Active
Contact: Mark David Hurwitz
Phone: 877-726-5130
Reading
Penn State Health Saint Joseph Medical Center
Status: Active
Contact: Navesh K. Sharma
Phone: 610-378-2336 Email: danielward2@catholichealth.net
West Reading
Reading Hospital
Status: Active
Contact: Terrence Paul Cescon
Phone: 610-988-9323
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: Active
Contact: Raghava Reddy Levaka Veera
Phone: 570-271-5251

South Carolina

Charleston
Medical University of South Carolina
Status: Active
Contact: David T. Marshall
Phone: 843-792-9321
Greenville
Greenville Health System Cancer Institute-Eastside
Status: Active
Contact: Jeffrey Kent Giguere
Phone: 864-679-3966
Greenville Health System Cancer Institute-Faris
Status: Active
Contact: Jeffrey Kent Giguere
Phone: 864-679-3966
Saint Francis Cancer Center
Status: Active
Contact: Jeremy M. Kilburn
Phone: 412-339-5294 Email: Roster@nrgoncology.org
Greenwood
Self Regional Healthcare
Status: Active
Contact: David T. Marshall
Phone: 843-792-9321
Greer
Gibbs Cancer Center-Pelham
Status: Active
Contact: Drew Carl Monitto
Phone: 412-339-5294 Email: Roster@nrgoncology.org
Greenville Health System Cancer Institute-Greer
Status: Active
Contact: Jeffrey Kent Giguere
Phone: 864-679-3966
Hilton Head Island
The Radiation Oncology Center-Hilton Head / Bluffton
Status: Active
Contact: Howard A. Zaren
Phone: 912-819-5704
Seneca
Greenville Health System Cancer Institute-Seneca
Status: Active
Contact: Jeffrey Kent Giguere
Phone: 864-679-3966
Spartanburg
Greenville Health System Cancer Institute-Spartanburg
Status: Active
Contact: Jeffrey Kent Giguere
Phone: 864-679-3966
Spartanburg Medical Center
Status: Active
Contact: Drew Carl Monitto
Phone: 800-486-5941

South Dakota

Sioux Falls
Avera Cancer Institute
Status: Active
Contact: Benjamin M. Solomon
Phone: 888-634-7268 Email: oncregulatory@avera.org
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Preston D. Steen
Phone: 712-252-0088

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Neil B. Desai
Phone: 214-648-7097
Galveston
University of Texas Medical Branch
Status: Active
Contact: Bagi Rathan Jana
Phone: 409-772-1950 Email: clinical.research@utmb.edu
League City
UTMB Cancer Center at Victory Lakes
Status: Active
Contact: Bagi Rathan Jana
Phone: 409-772-1950 Email: clinical.research@utmb.edu

Utah

Murray
Intermountain Medical Center
Status: Active
Contact: R. Jeffrey Lee
Phone: 801-408-1347
Ogden
McKay-Dee Hospital Center
Status: Active
Contact: R. Jeffrey Lee
Phone: 801-387-7426
Saint George
Dixie Medical Center Regional Cancer Center
Status: Active
Contact: R. Jeffrey Lee
Phone: 435-688-4167
Salt Lake City
LDS Hospital
Status: Active
Contact: R. Jeffrey Lee
Phone: 801-408-1347
Utah Cancer Specialists-Salt Lake City
Status: Active
Contact: R. Jeffrey Lee
Phone: 801-408-1347

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Active
Contact: Timothy Norman Showalter
Phone: 434-243-6322 Email: JME3D@hscmail.mcc.virginia.edu

Washington

Auburn
MultiCare Auburn Medical Center
Status: Active
Contact: John A. Keech
Phone: 253-887-9333

Wisconsin

Grafton
Aurora Cancer Care-Grafton
Status: Active
Contact: Rubina Qamar
Phone: 414-649-5717
Green Bay
Aurora BayCare Medical Center
Status: Active
Contact: Rubina Qamar
Phone: 414-649-5717
Marinette
Aurora Bay Area Medical Group-Marinette
Status: Active
Contact: Rubina Qamar
Phone: 414-219-4763
Marshfield
Marshfield Clinic
Status: Active
Contact: Seth Olusegun Fagbemi
Phone: 800-347-0673
Menomonee Falls
Community Memorial Hospital
Status: Active
Contact: Colleen A. F. Lawton
Phone: 262-257-5100
Mequon
Columbia Saint Mary's Hospital - Ozaukee
Status: Active
Contact: Craig Allan Schulz
Phone: 412-339-5294 Email: Roster@nrgoncology.org
Milwaukee
Aurora Saint Luke's Medical Center
Status: Active
Contact: Rubina Qamar
Phone: 414-649-5717
Aurora Sinai Medical Center
Status: Active
Contact: Rubina Qamar
Phone: 414-649-5717
Columbia Saint Mary's Water Tower Medical Commons
Status: Active
Contact: Craig Allan Schulz
Phone: 412-339-5294 Email: Roster@nrgoncology.org
Froedtert and the Medical College of Wisconsin
Status: Active
Contact: Colleen A. F. Lawton
Phone: 414-805-4380
Zablocki Veterans Administration Medical Center
Status: Active
Contact: Elizabeth M. Gore
Phone: 888-469-6614
Minocqua
Marshfield Clinic-Minocqua Center
Status: Active
Contact: Seth Olusegun Fagbemi
Phone: 800-347-0673
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: Active
Contact: Rubina Qamar
Phone: 414-649-5717
Rice Lake
Marshfield Clinic-Rice Lake Center
Status: Active
Contact: Seth Olusegun Fagbemi
Phone: 800-347-0673
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Status: Active
Contact: Rubina Qamar
Phone: 414-649-5717
Stevens Point
Marshfield Clinic Stevens Point Center
Status: Active
Contact: Seth Olusegun Fagbemi
Phone: 800-347-0673
Summit
Aurora Medical Center in Summit
Status: Active
Contact: Rubina Qamar
Phone: 414-649-5717
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: Active
Contact: Rubina Qamar
Phone: 414-649-5717
West Allis
Aurora West Allis Medical Center
Status: Active
Contact: Rubina Qamar
Phone: 414-649-5717
West Bend
The Alyce and Elmore Kraemer Cancer Care Center
Status: Active
Contact: Colleen A. F. Lawton
Phone: 866-680-0505
Weston
Diagnostic and Treatment Center
Status: Active
Contact: Seth Olusegun Fagbemi
Phone: 800-347-0673

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To assess the benefit of docetaxel as measured by improvement in freedom from progression (phase II) and subsequently metastasis free survival (phase III) when given in combination with radiation and androgen deprivation in treatment of high risk prostate cancer post-radical prostatectomy.

SECONDARY OBJECTIVES:

I. To assess overall survival.

II. To assess local time to progression.

III. To assess undetectable prostate-specific antigen (PSA) with a non-castrate testosterone at 2.5 years post treatment.

IV. To assess the utility of genomic profiling in making adjuvant therapy decisions post-prostatectomy.

V. To assess toxicity of docetaxel in the post-operative setting when combined with radiation and androgen deprivation therapy.

VI. To assess treatment response by genomically defined sub-groups of prostate cancer patients.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, bicalutamide, flutamide, or nilutamide for 6 months. Beginning 8 weeks after the start of androgen deprivation therapy, patients receive external beam radiation therapy (EBRT) for 7.5 weeks.

ARM II: Patients receive androgen deprivation therapy and EBRT as in Arm I. Within 4-6 weeks after completion of radiation therapy, patients receive docetaxel intravenously (IV) on day 1 of every 21 days for 6 courses in the absence of disease progression or unexpected toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, and then yearly.

Trial Phase & Type

Trial Phase

Phase II/III

Trial Type

Treatment

Lead Organization

Lead Organization
NRG Oncology

Principal Investigator
Mark David Hurwitz

Trial IDs

Primary ID NRG-GU002
Secondary IDs NCI-2016-00963
Clinicaltrials.gov ID NCT03070886