Status:
WITHDRAWN
Observation of Outcomes and Side Effects of Cesium-131 in Combination With External Beam Radiation for the Treatment of Intermediate to High Risk Prostate Cancer
Lead Sponsor:
IsoRay Medical, Inc.
Collaborating Sponsors:
Swedish Medical Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
The purpose of this study is to observe PSA response and incidence of side effects in patients diagnosed with intermediate to high risk prostate cancer and treated with Cesium-131 in combination of ex...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the prostate
- Clinical stage T1c - T2c (AJCC 6th Edition), NX/N0, M0
- Karnofsky Performance Score of 90 to 100
- Greater than or equal to 18 years of age
- Prostate volumes by TRUS ≤ 60 cc
- I-PSS score \< 15 (alpha blockers allowed)
- Signed study-specific informed consent form prior to study entry
- Intermediate Risk prostate cancer as determined by the following:
- Gleason sum of 7; PSA less than 10.1 ng/ml; Stage T2a or less
- Gleason sum 6 or less; PSA \>10.0 and \< 20.1ng/ml; Stage T2a or less
- Gleason sum 6 or less; PSA \< 10.1; Stage T2b
- High risk prostate cancer as determined by the following:
- Any Gleason Sum; PSA greater than 20 ng/ml; Stage T2c or less
- Gleason Sum \> 7; Any PSA; Stage T2c or less
- Any Gleason Sum; Any PSA; Stage T2c
- Any two or three intermediate risk factor
Exclusion
- Lymph node involvement (N1)
- Evidence of distant metastases (M1)
- Any hormonal blockade or therapy that:
- Has persisted for more than 6 months by time of protocol screening; OR
- Is ongoing within 3 months of study enrollment
- Radical surgery for carcinoma of the prostate
- Prior pelvic radiation
- Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years
- Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up
- Hip prosthesis
- Inability or refusal to provide informed consent
Key Trial Info
Start Date :
February 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00621413
Start Date
February 1 2007
End Date
February 1 2007
Last Update
April 19 2021
Active Locations (9)
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1
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
2
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
3
Dorthory Schneider Cancer Center
San Mateo, California, United States, 94401
4
Levine Cancer Center
Worcester, Massachusetts, United States, 01605