Status:
WITHDRAWN
Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE3
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not yet known which t...
Detailed Description
OBJECTIVES: * Compare the efficacy of neutron and photon radiotherapy vs hypofractionated intensity modulated radiation, in terms of a lower frequency of chronic complication rate (chronic toxicity a...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Stage I-III disease (T1-T3, N0, M0)
- No clinical or radiographic evidence of metastasis
- If prostate-specific antigen (PSA) ≥ 10.0 ng/mL and Gleason score is 7, a radioisotope bone scan must show no evidence of metastasis
- No evidence of lymphatic or visceral metastases of the abdomen or pelvis on CT scan or MRI
- PSA ≤ 20 ng/mL
- Gleason score ≤ 7 (if stage T3 , score must be \< 7)
- PATIENT CHARACTERISTICS:
- Performance status
- Not specified
- Life expectancy
- More than 10 years
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Other
- No other malignancy within the past 5 years except basal cell or squamous cell skin cancer
- PRIOR CONCURRENT THERAPY:
- Endocrine therapy
- Prior hormonal therapy allowed provided it was initiated no more than 2 months ago, and may include the following:
- Luteinizing hormone-releasing hormone agonists (e.g., goserelin, leuprolide)
- Anti-androgens (e.g., flutamide, bicalutamide)
- Radiotherapy
- No prior pelvic irradiation
- Surgery
- No prior radical prostatectomy
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00258466
Start Date
May 1 2005
End Date
November 1 2006
Last Update
April 8 2013
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