Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Radiation Therapy Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01368588
First received: June 7, 2011
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells.

PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.


Condition Intervention Phase
Prostate Cancer
Radiation: radiation therapy
Radiation: Whole-pelvic radiotherapy (WPRT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: From date of randomization to the date of death. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cause-specific survival [ Time Frame: From date of randomization to the date of death due to prostate cancer. ] [ Designated as safety issue: No ]
  • Distant metastasis-free survival [ Time Frame: From date of randomization to the date of first documented distant metastasis or date of first clinical and/or radiographic appearance of disseminated disease. ] [ Designated as safety issue: No ]
  • Biochemical failure by the Phoenix definition (PSA ≥ 2 ng/mL over the nadir PSA) [ Time Frame: From date of randomization to the date of first biochemical failure by phoenix definition within 5 years of randomization. ] [ Designated as safety issue: No ]
  • Incidence of "acute" adverse events as assessed by the Common Toxicity Criteria for Adverse Effects (CTCAE) current version [ Time Frame: From protocol treatment start date to the date of first occurrence of worst severity of the adverse event </= 30 days from completion of radiation therapy. ] [ Designated as safety issue: Yes ]
  • Time to "late" grade 3+ adverse events as assessed by CTCAE current version [ Time Frame: From protocol treatment start date to the date of the first late grade 3+ adverse event occurring more than 30 days after the completion of radiation therapy. ] [ Designated as safety issue: Yes ]
  • Prostate cancer-specific HRQOL change as measured by the EPIC-26 (bowel or urinary domain) [ Time Frame: Date when baseline EPIC-26 completed to 6 months post radiation therapy, 1 year post radiation therapy and 5 years post radiation therapy. ] [ Designated as safety issue: No ]
  • Fatigue status as measured by the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue-domain change score [ Time Frame: From the date when the baseline PROMIS is completed to the last week of treatment. ] [ Designated as safety issue: No ]
  • Assessment and comparison of Quality Adjusted Life Years (QALYs) [ Time Frame: From the baseline QALYs assessment to the last week of radiation therapy (RT), 3 months post RT, 6 months post RT, 1 year post RT and 5 years post RT. ] [ Designated as safety issue: No ]

Estimated Enrollment: 2580
Study Start Date: July 2011
Estimated Primary Completion Date: July 2027 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients undergo high-dose radiotherapy of the prostate and seminal vesicles using intensity-modulated radiotherapy (IMRT)* or 3D-conformal radiation therapy (3D-CRT)* once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo permanent prostate implant (PPI) brachytherapy or high-dose rate brachytherapy (I 125 or Pd 103 may be used as the radioisotope).
Radiation: radiation therapy
Undergo RT using IMRT or 3D-CRT
Experimental: Arm II
Patients undergo whole-pelvic radiotherapy (WPRT)* (3D-CRT or IMRT) once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo brachytherapy as in arm I.
Radiation: Whole-pelvic radiotherapy (WPRT)
Undergo whole-pelvic radiotherapy (WPRT)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate- to high-risk for recurrence as determined by one of the following combinations:

    • Gleason score 7-10 + T1c-T2b (palpation) + prostate-specific antigen (PSA) < 50 ng/mL (includes intermediate- and high-risk patients)
    • Gleason score 6 + T2c-T4 (palpation) or > 50% (positive) biopsies + PSA < 50 ng/mL
    • Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/mL
  • History and/or physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration
  • Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal CT or MR), (but not by nodal sampling, or dissection) within 90 days prior to registration

    • Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm
    • Patients status post a negative lymph node dissection are not eligible
  • No evidence of bone metastases (M0) on bone scan within 120 days prior to registration

    • Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis
  • Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 12 weeks (90 days) prior to registration
  • Study entry PSA should not be obtained during the following time frames:

    • Ten-day period following prostate biopsy
    • Following initiation of hormonal therapy
    • Within 30 days after discontinuation of finasteride
    • Within 90 days after discontinuation of dutasteride

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)
  • No prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years (1,095 days) and not in the pelvis

    • E.g., carcinoma in situ of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed
    • No prior hematological (e.g., leukemia, lymphoma, or myeloma) malignancy
  • No severe, active co-morbidity, defined as any of the following:

    • 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 registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects or severe liver dysfunction
    • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition

      • Protocol-specific requirements may also exclude immuno-compromised patients
      • HIV testing is not required for entry into this protocol
  • No patients who are sexually active and not willing/able to use medically acceptable forms of contraception
  • No prior allergic reaction to the hormones involved in this protocol

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
  • No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  • No prior 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), estrogens (e.g., diethylstilbestrol (DES) ), or surgical castration (orchiectomy)
  • No prior pharmacologic androgen ablation for prostate cancer unless the onset of androgen ablation is ≤ 45 days prior to the date of registration
  • No finasteride within 30 days prior to registration
  • No dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
  • No prior or concurrent cytotoxic chemotherapy for prostate cancer

    • Prior chemotherapy for a different cancer is allowable
  • No prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368588

  Hide Study Locations
Locations
United States, Alaska
Providence Cancer Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Clinical Trials Office - Providence Cancer Center    907-261-3109      
United States, Arizona
Arizona Center for Cancer Care - Peoria Recruiting
Peoria, Arizona, United States, 85381
Contact: Terry T. Lee    623-773-2873      
United States, California
Saint Agnes Cancer Center at Saint Agnes Medical Center Recruiting
Fresno, California, United States, 93720
Contact: Clinical Trials Office - Saint Agnes Cancer Center    559-450-7790    medresearch@samc.com   
Veterans Affairs Medical Center - Long Beach Recruiting
Long Beach, California, United States, 90822
Contact: Samar H. Azawi, MD    562-826-5606      
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Howard M. Sandler, MD    734-936-9338      
Memorial Medical Center Recruiting
Modesto, California, United States, 95355
Contact: Clinical Trials Office - Memorial Medical Center    209-572-7116      
Kaiser Permanente - Division of Research - Oakland Recruiting
Oakland, California, United States, 94611
Contact: Louis Fehrenbacher, MD    707-651-2577      
Kaiser Permanente Medical Center - Rancho Cordova Recruiting
Rancho Cordova, California, United States, 95670
Contact: Louis Fehrenbacher, MD    707-651-2577      
Rohnert Park Cancer Center Recruiting
Rohnert Park, California, United States, 94928
Contact: Louis Fehrenbacher, MD    707-651-2577      
Kaiser Permanente Medical Center - Roseville Recruiting
Roseville, California, United States, 95678
Contact: Louis Fehrenbacher, MD    707-651-2577      
South Sacramento Cancer Center Recruiting
Sacramento, California, United States, 95823
Contact: Louis Fehrenbacher, MD    707-651-2577      
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer    916-734-3089      
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi    877-827-3222      
Santa Clara Valley Medical Center Recruiting
San Jose, California, United States, 95128
Contact: Tri M. Do    408-885-5000      
Recruiting
Santa Clara, California, United States, 95051
Contact: Louis Fehrenbacher, MD    707-651-2577      
Kaiser Permanente Medical Center - South San Francisco Recruiting
South San Francisco, California, United States, 94080
Contact: Louis Fehrenbacher, MD    707-651-2577      
United States, Colorado
Rocky Mountain Cancer Centers - Aurora Recruiting
Aurora, Colorado, United States, 80012
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
McKee Medical Center Recruiting
Loveland, Colorado, United States, 80539
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
United States, Connecticut
St. Vincent's Medical Center Recruiting
Bridgeport, Connecticut, United States, 06606
Contact: Christopher M. Iannuzzi    203-576-6000      
United States, Delaware
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services    302-623-4450      
United States, Florida
North Broward Medical Center Recruiting
Dearfield Beach, Florida, United States, 33064-3596
Contact: Clinical Trials Office - North Broward Medical Center    954-941-8300      
Baptist Cancer Institute - Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Clinical Trials Office - Baptist Cancer Institute - Jacksonvil    904-202-7051      
Baptist Medical Center South Recruiting
Jascksonville, Florida, United States, 32258
Contact: Michael R. Olson    904-821-6000      
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Recruiting
Jupiter, Florida, United States, 33458
Contact: Clinical Trials Office - Ella Milbank Foshay Cancer Center    561-745-5768      
Florida Cancer Center - Palatka Recruiting
Palatka, Florida, United States, 32177
Contact: Michael R. Olson    386-325-8140      
21st Century Oncology - Plantation Recruiting
Plantation, Florida, United States, 33324
Contact: Christopher T. Chen    954-370-7555      
United States, Georgia
Emory Crawford Long Hospital Recruiting
Atlanta, Georgia, United States, 30308
Contact: Ashesh B. Jani    773-702-2526      
Piedmont Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Adam W. Nowlan    404-605-5000      
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Clinical Trials Office - Winship Cancer Institute    404-778-1900      
John B. Amos Cancer Center Recruiting
Columbus, Georgia, United States, 31904
Contact: Clinical Trials Office - John B. Amos Cancer Center    706-660-6404      
United States, Hawaii
Queen's Cancer Institute at Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Paul A. DeMare, MD, FACR    808-547-4771      
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Clinical Trials Office - Saint Alphonsus Cancer Care Center    208-367-7954      
United States, Illinois
Northwest Community Hospital Recruiting
Arlington Heights, Illinois, United States, 60005
Contact: Stephen S. Nigh, MD    847-618-6560      
Cancer Institute at St. John's Hospital Recruiting
Springfield, Illinois, United States, 62702
Contact: Cathy L. Clausen, MD    765-646-8358      
United States, Indiana
Radiation Oncology Associates Southwest Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Brian K. Chang    260-436-4116      
United States, Iowa
McFarland Clinic, PC Recruiting
Ames, Iowa, United States, 50010
Contact: Clinical Trials Office - McFarland Clinic, PC    515-239-2621      
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160-7357
Contact: Clinical Trials Office - Kansas Masonic Cancer Research Instit    913-588-4709      
Kansas City Cancer Centers - Southwest Recruiting
Overland Park, Kansas, United States, 66210
Contact: Fen Wang    913-234-0400      
Cotton-O'Neil Cancer Center Recruiting
Topeka, Kansas, United States, 66606
Contact: Clinical Trials Office - Cotton-O'Neil Cancer Center    785-270-4963      
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of    859-257-3379      
United States, Louisiana
Tulane Cancer Center Office of Clinical Research Recruiting
Alexandria, Louisiana, United States, 71315-3198
Contact: Clinical Trials Office - Tulane Cancer Center    504-988-6121      
Mary Bird Perkins Cancer Center - Baton Rouge Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Robert W. Veith    225-767-0847      
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit    800-888-8823      
St. Agnes Hospital Cancer Center Recruiting
Baltimore, Maryland, United States, 21229
Contact: Richard S. Hudes, MD    410-368-2965      
Central Maryland Oncology Center Recruiting
Columbia, Maryland, United States, 21044
Contact: Young Kwok    410-964-2212      
Tate Cancer Center at Baltimore Washington Medical Center Recruiting
Glen Burnie, Maryland, United States, 21061
Contact: Young Kwok    410-553-8100      
United States, Massachusetts
Hudner Oncology Center at Saint Anne's Hospital - Fall River Recruiting
Fall River, Massachusetts, United States, 02721
Contact: Clinical Trials Office - Hudner Oncology Center at Saint Anne'    508-674-5600 ext 2019      
Cape Cod Hospital Recruiting
Hyannis, Massachusetts, United States, 02601
Contact: Daniel J. Canaday    508-771-1800      
Lowell General Hospital Recruiting
Lowell, Massachusetts, United States, 01854
Contact: Jeffrey D. Goldstein    978-937-6000      
United States, Michigan
Hickman Cancer Center at Bixby Medical Center Recruiting
Adrian, Michigan, United States, 49221
Contact: Clinical Trials Office - Hickman Cancer Center at Bixby Medica    517-265-0116      
Josephine Ford Cancer Center at Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Eleanor M. Walker, MD    313-916-1021      
Butterworth Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D.A. Padula    616-391-2799      
Lacks Cancer Center at Saint Mary's Health Care Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D.A. Padula    616-752-5222      
St. Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Samir Narayan    734-464-4800      
Seton Cancer Institute at Saint Mary's - Saginaw Recruiting
Saginaw, Michigan, United States, 48601
Contact: Clinical Trials Office - Seton Cancer Institute - Saginaw    989-776-8411      
United States, Minnesota
Albert Lea Cancer Center at Albert Lea Medical Center Recruiting
Albert Lea, Minnesota, United States, 56007
Contact: Timothy F. Kozelsky, MD    507-379-2050      
Immanuel St. Joseph's Recruiting
Mankato, Minnesota, United States, 56002
Contact: Ron S. Smith    507-345-2929      
United States, Mississippi
Regional Cancer Center at Singing River Hospital Recruiting
Pascagoula, Mississippi, United States, 39581
Contact: James E. Clarkson, MD    228-374-6296      
United States, Missouri
Kansas City Cancer Centers - South Recruiting
Kansas City, Missouri, United States, 64131
Contact: Fen Wang    816-333-1326      
Kansas City Cancer Centers - North Recruiting
Kansas City, Missouri, United States, 64154
Contact: Fen Wang    816-746-4570      
Kansas City Cancer Centers - East Recruiting
Lee's Summit, Missouri, United States, 64064
Contact: Fen Wang    816-478-2050      
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jeff M. Michalski, MD    314-362-8566      
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters Recruiting
Saint Peters, Missouri, United States, 63376
Contact: Jeff M. Michalski, MD    314-362-8566      
Hulston Cancer Center at Cox Medical Center South Recruiting
Springfield, Missouri, United States, 65807
Contact: Robert L. Carolla    417-269-5257      
United States, Nevada
Renown Institute for Cancer at Renown Regional Medical Center Recruiting
Reno, Nevada, United States, 89502
Contact: Daniel W. Weed    775-982-5050      
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-0002
Contact: Clinical Trials Office - Norris Cotton Cancer Center    603-650-7609    cancerhelp@dartmouth.edu   
United States, New Jersey
Frederick R. and Betty M. Smith Cancer Treatment Center Recruiting
Sparta, New Jersey, United States, 07871
Contact: Maria Werner-Wasik, MD    215-955-7679      
United States, New York
New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Sameer Rafla-Demetrious, MD, PhD, FRCR, FACR, FRSM    718-780-3677      
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Louis Potters, MD, FACR    516-632-3370      
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente    877-668-0683      
Contact: Clinical Trials Office    919-966-4432      
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Cancer Institute    888-275-3853      
Coleman Radiation Oncology Center at Carter General Hospital Recruiting
Morehead City, North Carolina, United States, 28557
Contact: Michael A. Papagikos    252-808-6191      
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center Recruiting
Pinehurst, North Carolina, United States, 28374
Contact: Clinical Trials Office - FirstHealth Moore Regional Community    910-715-2200      
South Atlantic Radiation Oncology, LLC Recruiting
Supply, North Carolina, United States, 28462
Contact: Michael A. Papagikos    910-754-4716      
Coastal Carolina Radiation Oncology Center Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Michael A. Papagikos    910-251-1839      
Forsyth Regional Cancer Center at Forsyth Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Clinical Trials Office - Forsyth Regional Cancer Center at For    336-277-8887      
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive    336-713-6771      
United States, North Dakota
CCOP - MeritCare Hospital Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston D. Steen, MD    701-234-2397      
United States, Ohio
McDowell Cancer Center at Akron General Medical Center Recruiting
Akron, Ohio, United States, 44307
Contact: Mitchell L. Fromm, MD    330-344-6448      
Summa Center for Cancer Care at Akron City Hospital Recruiting
Akron, Ohio, United States, 44309-2090
Contact: Clinical Trials Office - Akron City Hospital    330-375-6101      
Barberton Citizens Hospital Recruiting
Barberton, Ohio, United States, 44203
Contact: William F. Demas, MD    330-375-3557      
Adena Regional Medical Center Recruiting
Chillicothe, Ohio, United States, 45601
Contact: Clinical Trials Office - Adena Regional Medical Center    877-779-7585      
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center    800-641-2422      
Zangmeister Center Recruiting
Columbus, Ohio, United States, 43219
Contact: J. Philip Kuebler, MD, PhD    614-442-3130      
Lake/University Ireland Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: Rodney J. Ellis    440-205-5755      
Southwest General Health Center Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact: Rodney J. Ellis    440-816-8000      
UHHS Chagrin Highlands Medical Center Recruiting
Orange Village, Ohio, United States, 44122
Contact: Rodney J. Ellis    216-292-1783      
Cancer Care Center, Incorporated Recruiting
Salem, Ohio, United States, 44460
Contact: William F. Demas, MD    330-375-3557      
Flower Hospital Cancer Center Recruiting
Sylvania, Ohio, United States, 43560
Contact: Clinical Trials Office - Flower Hospital Cancer Center    419-824-1842      
St. Anne Mercy Hospital Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex B. Mowat    419-407-2663      
UHHS Westlake Medical Center Recruiting
Westlake, Ohio, United States, 44145
Contact: Rodney J. Ellis    440-250-2001      
Cancer Treatment Center Recruiting
Wooster, Ohio, United States, 44691
Contact: Clinical Trials Office - Cancer Treatment Center    330-375-4221      
United States Air Force Medical Center - Wright-Patterson Recruiting
Wright-Patterson Afb, Ohio, United States, 45433-5529
Contact: William K.J. Skinner    937-257-9133      
United States, Oklahoma
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Terence S. Herman    405-271-6822      
United States, Oregon
Clackamas Radiation Oncology Center Recruiting
Clackamas, Oregon, United States, 97015
Contact: Matthew C. Solhjem    503-513-3300      
Dubs Cancer Center at Rogue Valley Medical Center Recruiting
Medford, Oregon, United States, 97504
Contact: Gordon L. Metz, MD    541-608-4263      
Providence Cancer Center at PMCC Recruiting
Medford, Oregon, United States, 97504
Contact: Gordon L. Metz, MD    541-608-4263      
Providence Cancer Center at Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213-2967
Contact: Clinical Trials Office - Providence Cancer Center at Providenc    503-215-6412      
Providence St. Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Clinical Trials Office - Providence St. Vincent Medical Center    503-215-6412      
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Clinical Trials Office - Rosenfeld Cancer Center at Abington M    215-481-2402      
Adams Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Amir Tabatabai, MD    717-741-9229      
Cherry Tree Cancer Center Recruiting
Hanover, Pennsylvania, United States, 17331
Contact: Amir Tabatabai, MD    717-741-9229      
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Clinical Trials Office - Penn State Hershey Cancer Institute a    717-531-3779    CTO@hmc.psu.edu   
Upper Delaware Valley Cancer Center Recruiting
Milford, Pennsylvania, United States, 18337
Contact: Maria Werner-Wasik, MD    215-955-7679      
Fox Chase Cancer Center - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi    215-728-4790      
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Recruiting
Reading, Pennsylvania, United States, 19612-6052
Contact: Clinical Trials Office - McGlinn Family Regional Cancer Center    610-988-9323      
York Cancer Center at Apple Hill Medical Center Recruiting
York, Pennsylvania, United States, 17405
Contact: Amir Tabatabai, MD    717-741-9229      
United States, South Carolina
CCOP - Greenville Recruiting
Greenville, South Carolina, United States, 29615
Contact: David L. Grisell    864-241-6251      
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Clinical Trials Office - Gibbs Regional Cancer Center    800-486-5941      
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555-0361
Contact: Clinical Trials Office - University of Texas Medical Branch    409-772-1950      
United States, Utah
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: R. Jeffrey Lee, MD    801-408-1146      
Utah Valley Regional Medical Center - Provo Recruiting
Provo, Utah, United States, 84604
Contact: Clinical Trials Office - Utah Valley Regional Medical Center -    801-357-7965      
Dixie Regional Medical Center - East Campus Recruiting
Saint George, Utah, United States, 84770
Contact: Clinical Trials Office - Dixie Regional Medical Center - East    435-688-4167      
Utah Cancer Specialists at UCS Cancer Center Recruiting
Salt Lake City, Utah, United States, 84106
Contact: R. Jeffrey Lee, MD    801-408-1146      
United States, Vermont
Norris Cotton Cancer Center - North Recruiting
Saint Johnsbury, Vermont, United States, 05819
Contact: Alan C. Hartford, MD, PhD    603-650-6600      
United States, Virginia
RMH Regional Cancer Center at Rockingham Memorial Hospital Recruiting
Harrisonburg, Virginia, United States, 22801
Contact: Heather Anne W. Morgan    540-564-5570      
Sentara Cancer Institute at Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Clinical Trials Office - Sentara Cancer Institute at Sentara N    757-388-2406      
Coastal Cancer Center at Sentara Virginia Beach General Hospital Recruiting
Virginia Beach, Virginia, United States, 23454
Contact: Mark E. Shaves    757-395-8686      
United States, Washington
CCOP - Virginia Mason Research Center Recruiting
Seattle, Washington, United States, 98101
Contact: Huong T. Pham, MD    206-223-6801      
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Recruiting
Yakima, Washington, United States, 98902
Contact: Clinical Trails Office - North Star Lodge Cancer Center    509-574-3422      
United States, Wisconsin
Theda Care Cancer Institute Recruiting
Appleton, Wisconsin, United States, 54911
Contact: Clinical Trials Office - Theda Care Cancer Institute    920-380-1500      
Luther Midlelfort Hospital Recruiting
Eau Claire, Wisconsin, United States, 54703
Contact: Gopakumar S. Nambudiri    715-838-3311      
St. Mary's Hospital Medical Center - Green Bay Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Gregory M. Cooley, MD    414-433-8184      
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311
Contact: Clinical Trials Office - Vince Lombardi Cancer Clinic - Green    414-649-5717      
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer    920-433-8889      
Franciscan Skemp Healthcare - La Crosse Campus Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Michelle A. Neben-Wittich    608-785-0940      
Gundersen Lutheran Center for Cancer and Blood Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center    608-775-2385    cancerctr@gundluth.org   
Bay Area Cancer Care Center at Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Gregory M. Cooley, MD    414-433-8184      
Columbia Saint Mary's Hospital - Ozaukee Recruiting
Mequon, Wisconsin, United States, 53097
Contact: Carl E. Olson, MD    414-291-1556    clinicaltrials@columbia-stmarys.org   
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Clinical Trials Office - Vince Lombardi Cancer Clinic    414-649-5717      
Veterans Affairs Medical Center - Milwaukee Recruiting
Milwaukee, Wisconsin, United States, 53295
Contact: Elizabeth M. Gore, MD    414-805-4369      
Medical College of Wisconsin Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C    414-805-4380      
Columbia-Saint Mary's Water Tower Medical Commons Recruiting
Milwaukee, Wisconsin, United States, 53211
Contact: Clinical Trials Office - Columbia-St. Mary's Cancer Care Cente    414-326-1739    clinicaltrials@columbia-stmarys.org   
Vince Lombardi Cancer Clinic - Sheboygan Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Clinical Trials Office - Vince Lombardi Cancer Clinic - Sheboy    414-649-7200      
Door County Cancer Center at Door County Memorial Hospital Recruiting
Sturgeon Bay, Wisconsin, United States, 54235-1495
Contact: Gregory M. Cooley, MD    414-433-8184      
Aurora Medical Center Recruiting
Summit, Wisconsin, United States, 53066
Contact: David C. Rohde, MD    920-288-4160      
West Allis Memorial Hospital Recruiting
West Allis, Wisconsin, United States, 53227
Contact: Clinical Trials Office - West Allis Memorial Hospital    414-649-5717      
Canada, Alberta
Tom Baker Cancer Centre - Calgary Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Michael A. Sia    403-521-3723      
Cross Cancer Institute at University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Brita L. Danielson    780-432-8771      
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Juanita M. Crook    250-712-3900      
Canada, Newfoundland and Labrador
Doctor H. Bliss Murphy Cancer Centre Recruiting
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: John W. Thoms    709-777-7589      
Canada, Nova Scotia
Nova Scotia Cancer Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 1V8
Contact: David M.C. Bowes    902-473-6000      
Canada, Ontario
London Regional Cancer Program at London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4L6
Contact: George B. Rodrigues    519-685-8615      
Odette Cancer Centre at Sunnybrook Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Hans T. Chung    416-480-5000      
Canada, Quebec
Hopital Notre-Dame du CHUM Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Jean-Paul Bahary    514-281-6000      
McGill Cancer Centre at McGill University Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Fabio L.B. Cury    514-398-1444      
Centre Hospitalier Universitaire de Quebec Recruiting
Quebec City, Quebec, Canada, G1R 2J6
Contact: Eric Vigneault    418-525-4444      
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Evgeny Sadikov    306-766-2203      
Saskatoon Cancer Centre at the University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Ali A. El-Gayed    306-655-2662      
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Mack Roach, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01368588     History of Changes
Other Study ID Numbers: RTOG-0924, CDR0000701128, NCI-2011-02674
Study First Received: June 7, 2011
Last Updated: June 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the prostate
stage I prostate cancer
stage IIA prostate cancer
stage IIB prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014