Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase IV | Treatment | Active | 18 and over | Other | 11-022 NCT01352598 |
Summary
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.
Further Study Information
This is a single site, non-randomized, prospective, phase IV trial of patients with organ-confined prostate cancer. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues,tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
Eligibility Criteria
Inclusion Criteria:
- Patient age >= 18 years
- Zubrod performance status of 0-3
- T1-3 N0 M0 adenocarcinoma of the prostate
- Prostate volume ≤ 100 cc
- Signed study-specific consent form
Exclusion Criteria
- Extension of local tumor to involve adjacent organs other than seminal vesicles (T4)
- Prostate volume > 100 cc
- Nodal involvement
- Metastatic disease
- Prior pelvic radiotherapy except as part of combination therapy for prostate cancer
- History of scleroderma
- Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
Trial Lead Organizations/Sponsors
David C. Pratt Cancer Center at St. John's Mercy
| Jaymeson Stroud, MD | ![]() | Ph: 314-251-6844 |
| Email: jaymeson.stroud@mercy.net | ||
Trial Sites
| U.S.A. | |||
| Missouri | |||
| St. Louis | |||
| David C. Pratt Cancer Center at St. John's Mercy | |||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01352598
Information obtained from ClinicalTrials.gov on November 20, 2012
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