Status:
COMPLETED
Phase I/II Hypofractionated Radiotherapy for Prostate Cancer
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to examine the clinical feasibility of using Intensity-modulated radiation therapy (IMRT) combined with daily pretreatment prostate localization to deliver increasingly hy...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically proven adenocarcinoma of the prostate.
- Stage ≤ T2b disease, as defined by 1997 American Joint Committee on Cancer (AJCC) classification
- Predicted risk of lymph node involvement (by standard nomograms) of 15% or less (24), OR histologically negative pelvic nodes
- Gleason score ≤ 7
- No evidence of distant metastasis
- Age 18+
- Informed consent signed in accordance with institutional protocol
- Pretreatment evaluations must be completed as specified in Section 7.0.
- ECOG performance status 0-1
- No previous or concurrent cancers, other than localized basal cell or squamous cell skin carcinoma, unless continually disease free for at least 5 years
- No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- Gonadotropin-releasing hormone agonist (GnRH-a) use permitted (maximum of 6 months duration). Anti-androgen therapy permitted concurrently with GnRH-a.
- No previous or concurrent cytotoxic chemotherapy
- No radical surgery or cryosurgery for prostate cancer
- The absence of any co-morbid medical condition which would constitute a contraindication for radical radiotherapy
- The absence of serious concurrent illness of psychological, familial, sociological, geographical or other concomitant conditions which do not permit adequate follow-up and compliance with the study protocol.
- No current use of anticoagulation therapy, other than aspirin.
Exclusion
Key Trial Info
Start Date :
October 14 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2017
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT00214097
Start Date
October 14 2002
End Date
August 21 2017
Last Update
November 25 2019
Active Locations (1)
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1
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792