Status:
COMPLETED
Radiation Therapy in Treating Patients With Prostate Cancer
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
NRG Oncology
Conditions:
Prostate Cancer
Psychosocial Effects of Cancer and Its Treatment
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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...
Detailed 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 Ur...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2022
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT01434290
Start Date
September 1 2011
End Date
May 20 2022
Last Update
June 9 2022
Active Locations (37)
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1
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
2
Arizona Center for Cancer Care - Peoria
Peoria, Arizona, United States, 85381
3
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
4
Kaiser Permanente - Division of Research - Oakland
Oakland, California, United States, 94611