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A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer

Description

Detailed Description
OBJECTIVES: Primary - Demonstrate an overall survival (OS) advantage in patients with intermediate-risk prostate cancer treated with dose-escalated radiotherapy (RT) with versus without short-term androgen-deprivation therapy (ADT). Secondary - Determine whether the addition of ADT to dose-escalated RT versus RT alone improves clinical failures, biochemical failure by the "nadir +2", freedom from failure, rate of salvage ADT, and prostate cancer-specific mortality in these patients. - Estimate the magnitude of benefit of ADT with respect to OS in patients treated with different RT modalities (i.e., external-beam radiation therapy alone vs low-dose rate brachytherapy boost vs high-dose rate brachytherapy boost). - Compare acute and late treatment adverse events of these regimens and correlate these events with the presence or absence of pre-existing comorbidity as documented by the Adult Comorbidity Evaluation 27 assessment. OUTLINE: This is a multicenter, dose-escalation study of radiotherapy. Patients are stratified according to number of risk factors (1 vs 2-3), comorbidity (ACE-27 grade ≥ 2 vs < 2), and radiotherapy (RT) modality (dose-escalated external-beam RT [EBRT] vs EBRT and low-dose rate brachytherapy boost vs EBRT and high-dose rate brachytherapy boost). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo EBRT* once daily on days 1-5 for about 9 weeks (44 treatments). Some patients instead receive EBRT with high-dose rate or low-dose rate brachytherapy implant on days 1-5 for about 5 weeks (25 treatments). NOTE: *Type of RT is at discretion of treating physician and may include either 3D-conformal RT or intensity-modulated RT. - Arm II: Patients receive androgen-deprivation therapy comprising luteinizing-hormone releasing-hormone (LHRH) agonist (leuprolide, goserelin, buserelin, or triptorelin) subcutaneously or as an injection every 1 to 3 months AND an oral antiandrogen therapy (flutamide 3 times daily or bicalutamide once daily) for 6 months. Beginning 8 weeks after the first LHRH injection, patients undergo radiotherapy as in arm I. After completion of study therapy, patients are followed up periodically.

Phase

N/A

Inclusion and Exclusion Criteria

  • Histologically confirmed adenocarcinoma of the prostate diagnosed within the past 180 days and at intermediate-risk for recurrence by meeting ≥ 1 of the following criteria:
  • Gleason score > 7
  • Prostate Specific Antigen (PSA) > 10 and ≤ 20 ng/mL
  • Baseline serum PSA value performed within 60 days with an FDA-approved assay (e.g., Abbott, Hybritech)
  • Baseline PSA must not be obtained during any of the following time frames:10-day period after prostate biopsy, after initiation of androgen-deprivation therapy, or within the past 30 days after discontinuation of finasteride (90 days for dutasteride)
  • Clinical stage T2b or T2c disease
  • Patients previously diagnosed with low-risk (Gleason score < 6, clinical stage < T2a, and PSA < 10 ng/mL) prostate cancer undergoing active surveillance who are re-biopsied and found to have intermediate-risk disease according to the protocol criteria are eligible for enrollment within 6 months of the repeat biopsy procedure
  • Patients with Gleason Score ≥ 8, PSA > 20 ng/mL, OR clinical stage ≥ T3 are ineligible for this trial
  • If findings of extracapsular extension or seminal vesicle invasion are noted on prostate MRI, this study, if used, will not render patients ineligible for accrual to this protocol
  • Primary tumor staging for eligibility purposes is to be based on palpable or core biopsy evidence only with respect to extracapsular extension or seminal vesicle involvement
  • No patients with all 3 intermediate-risk factors who also have ≥ 50% of the number of their biopsy cores positive for cancer
  • The percentage of biopsy cores involved will only be considered with respect to eligibility for those patients with all 3 of the above risk factors (i.e., patients with one or two of the above risk factors are eligible irrespective of the percentage of biopsy cores involved)
  • Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal CT scan or MRI), nodal sampling, or dissection within the past 60 days (required for patients with 2-3 risk factors)
  • Abdominal imaging not required for a single intermediate-risk factor (these studies may be obtained at the discretion of the treating physician)
  • Lymph nodes that are equivocal or questionable by imaging allowed without biopsy if nodes ≤ 1.5 cm
  • Any node > 1.5 cm on imaging requires a negative biopsy
  • No evidence of bone metastases on bone scan within the past 60 days
  • Bone scan not required for patients with a single intermediate-risk factor (scan may be obtained at the discretion of the treating physician)
  • Equivocal bone scan findings allowed if plain film x-rays negative for metastasis PATIENT CHARACTERISTICS:
  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1,800/mm^3*
  • Platelet count ≥ 100,000/mm^3*
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve level allowed)*
  • NOTE: *For patients undergoing brachytherapy only.
  • Fertile patients must use effective contraception during and for the 3 months after cessation of protocol treatment
  • No invasive malignancy or hematological malignancy (e.g., leukemia, lymphoma, myeloma) within the past 5 years except adequately treated non-melanomatous skin cancer
  • Prior diagnoses of carcinoma in situ allowed
  • No severe or active co-morbidity with any of the following:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
  • Transmural myocardial infarction within the past 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy, within the past 30 days
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • Laboratory tests for liver function and coagulation parameters not required for entry into this protocol
  • AIDS based upon current Centers for Disease Control (CDC) definition
  • HIV testing not required for entry into this protocol
  • HIV-seropositive patients who do not meet criteria for diagnosis of AIDS allowed PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No prior radical surgery (prostatectomy), high-intensity focused ultrasound, or cryosurgery for prostate cancer
  • No prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy
  • No finasteride within past 30 days (90 days for dutasteride)
  • No prior or concurrent cytotoxic chemotherapy for prostate cancer
  • Prior chemotherapy for a different cancer allowed
  • No prior radiotherapy (RT), including brachytherapy, to the region of the study cancer that would result in overlap of RT fields
  • Patients undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume < 60 cc, American Urological Association (AUA) score ≤ 15 within the past 60 days of registration, and no history of prior transurethral resection of the prostate (TURP)
  • TURP allowed for patients who receive external-beam radiation therapy only

Sites

  • California

    • Los Angeles County-USC Medical Center, Los Angeles, California, 90033
    • University of Southern California/Norris Cancer Center, Los Angeles, California, 90033
    • 21st Century Oncology - El Segundo, El Segundo, California, 90245
    • Veterans Administration Long Beach Medical Center, Long Beach, California, 90822
    • University of California At San Diego, San Diego, California, 92103
    • Stanford University Hospitals and Clinics, Stanford, California, 94305
    • Kaiser Permanente, Hayward, Hayward, California, 94545
    • Kaiser Permanente Cancer Treatment Center, South San Francisco, California, 94080
    • Kaiser Permanente Oakland-Broadway, Oakland, California, 94611
    • Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, 94704
    • UCSF-Mount Zion, San Francisco, California, 94115
    • California Pacific Medical Center, San Francisco, California, 94118
    • South Sacramento Cancer Center, Sacramento, California, 95823
    • Kaiser Permanente-Rancho Cordova Cancer Center, Rancho Cardova, California, 95670
    • University of California at Davis Cancer Center, Sacramento, California, 95817
    • Sutter Solano Medical Center, Vallejo, California, 94589
    • Marin General Hospital, Greenbrae, California, 94904
    • Radiological Associates of Sacramento, Sacramento, California, 95815
    • The Permanente Medical Group-Roseville Radiation Oncology, Roseville, California, 95678
    • Rohnert Park Cancer Center, Rohnert Park, California, 94928

  • Arizona

    • Arizona Center for Cancer Care-Peoria, Peoria, Arizona, 85381
    • 21st Century Oncology-Scottsdale, Scottsdale, Arizona, 85251
    • Mayo Clinic in Arizona, Scottsdale, Arizona, 85259

  • Utah

    • Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, 84112

  • Oregon

    • Rogue Valley Medical Center, Medford, Oregon, 97504
    • Providence Medford Medical Center, Medford, Oregon, 97504
    • Three Rivers Community Hospital, Grants Pass, Oregon, 97527
    • Providence Milwaukie Hospital, Milwaukie, Oregon, 97222
    • Legacy Mount Hood Medical Center, Gresham, Oregon, 97030
    • Legacy Good Samaritan Hospital and Medical Center, Portland, Oregon, 97210

  • Colorado

    • Saint Mary's Hospital and Regional Medical Center, Grand Junction, Colorado, 81502
    • The Shaw Regional Cancer Center, Edwards, Colorado, 81632
    • The Urology Center of Colorado, Denver, Colorado, 80211
    • Rocky Mountain Cancer Centers-Aurora, Aurora, Colorado, 80012
    • Poudre Valley Radiation Oncology, Fort Collins, Colorado, 80528

  • New Mexico

    • Lovelace Medical Center-Downtown, Albuquerque, New Mexico, 87102
    • University of New Mexico Cancer Center, Albuquerque, New Mexico, 87106
    • Radiation Oncology Associates, Albuquerque, New Mexico, 87109
    • Memorial Medical Center - Las Cruces, Las Cruces, New Mexico, 88011

  • Idaho

    • Idaho Urologic Institute PA, Meridian, Idaho, 83642

  • Washington

    • Compass Oncology Vancouver, Vancouver, Washington, 98684
    • Legacy Salmon Creek Hospital, Vancouver, Washington, 98686
    • Saint Joseph Medical Center, Tacoma, Washington, 98405

  • Montana

    • Bozeman Deaconess Cancer Center, Bozeman, Montana, 59715

  • Kansas

    • Cancer Center of Kansas - Dodge City, Dodge City, Kansas, 67801
    • Cancer Center of Kansas - Wellington, Wellington, Kansas, 67152
    • Wesley Medical Center, Wichita, Kansas, 67214
    • Wichita CCOP, Wichita, Kansas, 67214
    • Cancer Center of Kansas - Main Office, Wichita, Kansas, 67214
    • Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, 67208
    • Associates In Womens Health, Wichita, Kansas, 67208
    • Cancer Center of Kansas - Winfield, Winfield, Kansas, 67156
    • Cancer Center of Kansas - El Dorado, El Dorado, Kansas, 67042
    • Lawrence Memorial Hospital, Lawrence, Kansas, 66044
    • University of Kansas Medical Center, Kansas City, Kansas, 66160

  • Texas

    • Texas Oncology-Wichita Falls Texoma Cancer Center, Wichita Falls, Texas, 76310
    • Brooke Army Medical Center, Fort Sam Houston, Texas, 78234
    • University of Texas Southwestern Medical Center, Dallas, Texas, 75390
    • M D Anderson Cancer Center, Houston, Texas, 77030

  • Nebraska

    • Missouri Valley Cancer Consortium CCOP, Omaha, Nebraska, 68106

  • Missouri

    • Mercy Hospital-Joplin, Joplin, Missouri, 64804
    • Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield, Springfield, Missouri, 65802
    • CoxHealth South Hospital, Springfield, Missouri, 65807
    • Mercy Hospital Springfield, Springfield, Missouri, 65804
    • Siteman Cancer Center - Saint Peters, Saint Peters, Missouri, 63376
    • Barnes-Jewish West County Hospital, Saint Louis, Missouri, 63141
    • Siteman Cancer Center-South County, Saint Louis, Missouri, 63129
    • Washington University School of Medicine, Saint Louis, Missouri, 63110

  • North Dakota

    • Sanford Clinic North-Fargo, Fargo, North Dakota, 58122

  • Minnesota

    • Mayo Clinic Health Systems-Mankato, Mankato, Minnesota, 56001
    • Mayo Clinic Health System in Albert Lea, Albert Lea, Minnesota, 56007
    • Fairview-Southdale Hospital, Edina, Minnesota, 55435
    • Mayo Clinic, Rochester, Minnesota, 55905

  • Wisconsin

    • Mayo Clinic Health System-Franciscan Healthcare, La Crosse, Wisconsin, 54601
    • Agnesian Cancer Center, Fond Du Lac, Wisconsin, 54935
    • Community Memorial Hospital, Menomonee Falls, Wisconsin, 53051
    • Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, 53226
    • Appleton Medical Center, Appleton, Wisconsin, 54911
    • Columbia Saint Mary's Hospital - Ozaukee, Mequon, Wisconsin, 53097
    • Wheaton Franciscan Cancer Care - All Saints, Racine, Wisconsin, 53405
    • Columbia Saint Mary's Water Tower Medical Commons, Milwaukee, Wisconsin, 53211
    • Bellin Memorial Hospital, Green Bay, Wisconsin, 54301

  • Illinois

    • Memorial and Saint Elizabeth's Health Care Services LLP, Swansea, Illinois, 62226
    • Loyola University Medical Center, Maywood, Illinois, 60153
    • Hines Veterans Administration Hospital, Hines, Illinois, 60141
    • Advocate Illinois Masonic Medical Center, Chicago, Illinois, 60657
    • University of Chicago, Chicago, Illinois, 60637

  • Iowa

    • Finley Hospital, Dubuque, Iowa, 52001

  • Kentucky

    • Owensboro Health Mitchell Memorial Cancer Center, Owensboro, Kentucky, 42303
    • The James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky, 40202
    • Baptist Health Lexington, Lexington, Kentucky, 40503
    • University of Kentucky, Lexington, Kentucky, 40536

  • Indiana

    • Indiana University Health Bloomington, Bloomington, Indiana, 47403
    • Richard L. Roudebush Veterans Affairs Medical Center, Indianapolis, Indiana, 46202
    • Indiana University Medical Center, Indianapolis, Indiana, 46202
    • IU Health Methodist Hospital, Indianapolis, Indiana, 46202
    • Saint Francis Hospital and Health Centers, Beech Grove, Indiana, 46107
    • IU Health Central Indiana Cancer Centers-Indianapolis, Indianapolis, Indiana, 46219
    • IU Health Goshen Center for Cancer Care, Goshen, Indiana, 46526
    • Saint Vincent Anderson Regional Hospital/Cancer Center, Anderson, Indiana, 46016
    • Reid Hospital and Health Care Services, Richmond, Indiana, 47374

  • Alabama

    • University of Alabama at Birmingham, Birmingham, Alabama, 35294

  • Michigan

    • McLaren-Central Michigan, Mount Pleasant, Michigan, 48858
    • Sparrow Hospital, Lansing, Michigan, 48912
    • McLaren Cancer Institute-Owosso, Owosso, Michigan, 48867

  • Ohio

    • Samaritan North Health Center, Dayton, Ohio, 45415
    • Good Samaritan Hospital - Dayton, Dayton, Ohio, 45406
    • Grandview Hospital, Dayton, Ohio, 45405
    • Upper Valley Medical Center, Troy, Ohio, 45373
    • Miami Valley Hospital, Dayton, Ohio, 45409
    • Kettering Medical Center, Kettering, Ohio, 45429

  • Georgia

    • John B Amos Cancer Center, Columbus, Georgia, 31904
    • Piedmont Fayette Hospital, Fayetteville, Georgia, 30214
    • Piedmont Hospital, Atlanta, Georgia, 30309
    • Grady Health System, Atlanta, Georgia, 30303
    • Emory University/Winship Cancer Institute, Atlanta, Georgia, 30322
    • Atlanta VA Medical Center, Decatur, Georgia, 30033

  • Florida

    • Bay Medical Center, Panama City, Florida, 32401
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