Status:
COMPLETED
Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer
Lead Sponsor:
Duke University
Conditions:
Prostate Cancer
Eligibility:
MALE
40-82 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the prostate. Stere...
Detailed Description
This protocol requires radiation treatments to be performed with a stereotactic technique with the use of a 3-D coordinate system defined by implanted transponders (i.e. Calypso) or use of the ExacTra...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of adenocarcinoma of the prostate within 365 days of study enrollment
- History/physical examination with digital rectal examination of the prostate within 8 weeks prior to study enrollment
- Gleason score less than or equal to 7
- Clinical Stage T1-T2c
- PSA
- less than or = 15 ng/ml prior to start of therapy if Gleason \< or = 6 or
- less than or = 10 ng/ml prior to start of therapy if Gleason = 7
- Zubrod Performance Status 0-1
- Age \> 40
Exclusion
- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (Carcinoma in situ of the bladder or oral cavity is permissible)
- Evidence of distant metastases
- Regional lymph node involvement
- Significant urinary obstruction
- Estimated prostate gland \> 100 grams
- Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
- Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- Previous hormonal therapy, such as LHRH agonists (e.g. goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (bilateral orchiectomy) or planned concurrent androgen deprivation therapy
- Previous or concurrent cytotoxic chemotherapy for prostate cancer
- Prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip).
- Severe, active comorbidity
Key Trial Info
Start Date :
November 9 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00941915
Start Date
November 9 2009
End Date
July 17 2020
Last Update
January 24 2022
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710