Status:
COMPLETED
Radiation Therapy in Treating Patients With Stage II Prostate Cancer
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
NRG Oncology
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE3
Brief Summary
RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving hypofractionated radiation therapy (highe...
Detailed Description
OBJECTIVES: Primary * Compare the disease-free survival (DFS) of patients with favorable-risk stage II prostate cancer treated with hypofractionated vs conventionally fractionated three-dimensional ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate within the past 6 months
- Clinical stage T1-2c
- Combined Gleason score 2-6
- Prostate-specific antigen (PSA) \< 10 ng/mL within the past 6 months
- PSA evaluated at least 10 days after prostate biopsy
- For patients who received finasteride, PSA evaluated at least 30 after completion of finasteride
- For patients who received dutasteride, PSA evaluated at least 90 after completion of dutasteride
- No regional lymph node involvement
- No distant metastases
- PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- No transmural myocardial infarction within the past 6 months
- No acute bacterial or fungal infection requiring IV antibiotics
- No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study treatment
- No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- No known AIDS
- No prior or concurrent lymphomatous/hematogenous malignancy or other invasive malignancy except nonmelanomatous skin cancer or any other cancer for which the patient has been continually disease-free for ≥ 5 years (e.g., carcinoma in situ of the bladder or oral cavity)
- No other severe, active comorbidity
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radical prostatectomy or cryosurgery for prostate cancer
- No prior hormonal therapy, including any of the following:
- Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)
- Antiandrogens (e.g., flutamide or bicalutamide)
- Estrogens \[e.g., diethylstilbestrol (DES)\]
- Surgical castration (bilateral orchiectomy)
- No prior pelvic radiotherapy or prostate brachytherapy
- No prior or concurrent cytotoxic chemotherapy for prostate cancer
- At least 30 days since prior finasteride
- At least 90 days since prior dutasteride
- No concurrent neoadjuvant or adjuvant hormonal therapy
- Concurrent warfarin or other blood-thinning agents allowed
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
1116 Patients enrolled
Trial Details
Trial ID
NCT00331773
Start Date
April 1 2006
End Date
December 22 2022
Last Update
January 18 2023
Active Locations (296)
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1
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
2
Arizona Oncology - Tucson
Tucson, Arizona, United States, 85704
3
Auburn Radiation Oncology
Auburn, California, United States, 95603
4
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704