Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
602 participants
INTERVENTIONAL
1998-01-31
2010-01-31
Brief Summary
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Research design A total of 600 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 2 to 6, PSA 4 to 10 ng/ml) will be randomized to implantation with I-125 (160 Gy) versus Pd-103 (115 Gy).
Detailed Description
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Research design A total of 600 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 2 to 6, PSA 4 to 10 ng/ml) will be randomized to implantation with I-125 (160 Gy) versus Pd-103 (115 Gy).
Methodology: Patients will be randomized by the method of random permuted blocks.
Cancer status will be monitored by serial serum PSA at 6, 12, 18 and 24 months and yearly thereafter. Treatment-related morbidity will be monitored by personal interview, using standard American Urologic Association and Radiation Therapy Oncology Group criteria at 1, 3, 6, 12 and 24 months. Patients with serum PSA above 1.0 ng/ml two years after treatment will be considered to have residual or recurrent cancer and to have failed therapy.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Radioactive seed implant to prostate
Eligibility Criteria
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Inclusion Criteria
* PSA 4-10
* Gleason score 5-6
Exclusion Criteria
40 Years
80 Years
MALE
No
Sponsors
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Schiffler Cancer Center
OTHER
VA Puget Sound Health Care System
FED
Principal Investigators
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Kent E Wallner, MD
Role: STUDY_CHAIR
Puget Sound Health Care system
Locations
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Puget Sound VA
Seattle, Washington, United States
Countries
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References
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Wallner K, Merrick G, True L, Sutlief S, Cavanagh W, Butler W. 125I versus 103Pd for low-risk prostate cancer: preliminary PSA outcomes from a prospective randomized multicenter trial. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1297-303. doi: 10.1016/s0360-3016(03)01448-2.
Wallner K, Merrick G, True L, Cavanagh W, Simpson C, Butler W. I-125 versus Pd-103 for low-risk prostate cancer: morbidity outcomes from a prospective randomized multicenter trial. Cancer J. 2002 Jan-Feb;8(1):67-73. doi: 10.1097/00130404-200201000-00012.
Other Identifiers
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IP
Identifier Type: -
Identifier Source: org_study_id