Prostate Cancer Clinical Trial
Radiation Therapy in Treating Patients With Prostate Cancer
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Given radiation therapy in different ways may kill more tumor cells.
PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works in treating patients with prostate cancer.
Full Description
OBJECTIVES:
Primary
To demonstrate that 1-year health-related quality of life (HRQOL) for at least one hypofractionated arm is not significantly lower than baseline as measured by the Bowel and Urinary domains of the Expanded Prostate Cancer Index Composite (EPIC) instrument.
Secondary
To estimate the degree of change in HRQOL in each arm for the Sexual and Hormonal EPIC domains and the Utilization of Sexual Medications/Devices from baseline to 1 year, 2 years, and 5 years.
To estimate the degree of change in global HRQOL in each arm as measured by the Euro Quality of Life, 5 dimensions (EQ-5D) from baseline to 1 year, 2 years, and 5 years.
To estimate the rate of acute and late gastrointestinal (GI) and genitourinary (GU) toxicity for each arm at 1, 2, and 5 years.
To estimate prostate-specific antigen (PSA) failure in each arm at 1, 2, and 5 years.
To estimate disease-free survival (DFS) in each arm at 1, 2, and 5 years.
To estimate Quality Adjusted Life Years for each arm at 1, 2, and 5 years using the EQ-5D and DFS.
To identify genetic markers associated with normal tissue toxicities resulting from radiotherapy.
To collect tumor tissue for biomarker studies.
To estimate EPIC bowel and urinary HRQOL as continuous variables.
OUTLINE: This is a multicenter study. Patients are stratified according to treatment techniques/machine (all linear accelerator-based treatment [excluding cyberknife] vs cyberknife vs protons). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients undergo hypofractionated radiotherapy using intensity-modulated radiation therapy (IMRT), cyberknife, or protons twice a week for approximately 2½ weeks (36.25 Gy total).
Arm II: Patients undergo hypofractionated radiotherapy using IMRT, cyberknife, or protons once a day, 5 days a week, for approximately 2½ weeks (51.6 Gy total).
Patients may undergo blood and tumor tissue collection for correlative studies.
Patients may also complete the Utilization of Sexual Medications/Devices, the European Questionnaire-5D, and the Bowel and Urinary domains of the Expanded Prostate Cancer Index Composite (EPIC) questionnaires at baseline and at 1, 2, and 5 years after completion of radiation therapy.
After completion of study therapy, patients are followed-up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days of randomization
History/physical examination with digital rectal examination of the prostate within 60 days prior to registration
Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores 2-6 within 180 days of randomization
Clinical stage T1-2a (AJCC 7th edition) within 90 days of randomization
Prostate-specific antigen (PSA) < 10 ng/mL within 60 days prior to registration;
PSA should not be obtained within 10 days after prostate biopsy
No evidence of distant metastases
No regional lymph node involvement
PATIENT CHARACTERISTICS:
Zubrod performance status 0-1
Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
No prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease-free for a minimum of 5 years (for example, carcinoma of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed)
No severe, active co-morbidity, defined as follows:
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
Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
Acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease Control (CDC) definition
HIV testing is not required for entry into this protocol
Protocol-specific requirements may also exclude immuno-compromised patients
PRIOR CONCURRENT THERAPY:
No prior radical surgery (prostatectomy), cryosurgery, or high-intensity focused ultrasonography (HIFU) 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., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol (DES)), or surgical castration (orchiectomy)
No finasteride within 30 days prior to registration
Prostate-specific antigen (PSA) should not be obtained prior to 30 days after stopping finasteride
No dutasteride within 90 days prior to registration
PSA should not be obtained prior to 90 days after stopping dutasteride
No prior or concurrent cytotoxic chemotherapy for prostate cancer
Patients on Coumadin or other blood-thinning agents are eligible for this study
No concurrent 3D-conformal radiation therapy
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There are 37 Locations for this study
Birmingham Alabama, 35294, United States
Peoria Arizona, 85381, United States
Phoenix Arizona, 85013, United States
Oakland California, 94611, United States
Rohnert Park California, 94928, United States
Roseville California, 95678, United States
San Francisco California, 94115, United States
Santa Clara California, 95051, United States
South San Francisco California, 94080, United States
Denver Colorado, 80211, United States
Atlanta Georgia, 30308, United States
Atlanta Georgia, 30322, United States
Honolulu Hawaii, 96813, United States
Boston Massachusetts, 02118, United States
Boston Massachusetts, 02215, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Chapel Hill North Carolina, 27599, United States
Cleveland Ohio, 44106, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74136, United States
Abington Pennsylvania, 19001, United States
Bensalem Pennsylvania, 19020, United States
Furlong Pennsylvania, 18925, United States
King Of Prussia Pennsylvania, 19406, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Charleston South Carolina, 29425, United States
Spartanburg South Carolina, 29303, United States
Charlottesville Virginia, 22908, United States
Milwaukee Wisconsin, 53211, United States
Milwaukee Wisconsin, 53226, United States
Edmonton Alberta, T6G 1, Canada
Hamilton Ontario, L8V 5, Canada
Kitchener Ontario, N2G 1, Canada
London Ontario, N6A 4, Canada
Montreal Quebec, H2L 4, Canada
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