Status:
COMPLETED
Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
NRG Oncology
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor ce...
Detailed Description
OBJECTIVES: Primary * Determine the rate of late grade 3 or greater genitourinary and gastrointestinal toxicity after treatment with external beam radiotherapy and high-dose rate brachytherapy in pa...
Eligibility Criteria
Inclusion
- Histologically confirmed, adenocarcinoma of the prostate, clinical stage T1c-T3b, N0, M0.
- Patient will have clinically negative nodes as established by imaging (pelvic computed tomography (CT), magnetic resonance imaging (MRI)).
- The patient will be clinically M0.
- Zubrod status 0-1.
- No prior pelvic or prostate radiation or chemotherapy for prostate cancer; induction hormonal therapy beginning ≤ 120 days prior to registration is acceptable.
- One of the following combinations of factors:
- Clinical stage T1c-T2c, Gleason score 2-6 and prostate-specific antigen (PSA) \>10 but ≤ 20 Clinical stage T3a-T3b, Gleason score 2-6 and PSA ≤ 20 Clinical stage T1c-T3b, Gleason score 7-10 and PSA ≤ 20
- Patients must sign a study-specific consent form prior to registration.
Exclusion
- Stage T4 disease.
- Lymph node involvement (N1).
- Evidence of distant metastases (M1).
- Radical surgery for carcinoma of the prostate.
- Previous hormonal therapy beginning \> 120 days prior to registration.
- Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
- Prior transurethral resection of the prostate (TURP).
- Prior invasive malignancy(except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the oral cavity or bladder are permissible).
- Hip prosthesis.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00091390
Start Date
July 1 2004
End Date
December 1 2016
Last Update
August 10 2020
Active Locations (12)
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1
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
2
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
Inglewood, California, United States, 90301
3
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
4
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045