Status:
COMPLETED
Pd-103 Dose De-Escalation for Early Stage Prostate Cancer: A Prospective Randomized Trial
Lead Sponsor:
Schiffler Cancer Center
Conditions:
Prostatic Neoplasm
Eligibility:
MALE
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the most appropriate radiation implant dose for palladium-103 monotherapy. Radiation dose is related to potential cure. From previously published studies, it ...
Detailed Description
In calendar year 2003, approximately 220, 000 men will be diagnosed with prostate cancer and approximately 30,000 will die. The vast majority of men will be diagnosed with clinically organ-confined di...
Eligibility Criteria
Inclusion
- Low risk patients: Gleason score less than or equal to 6, PSA less than or equal to 10 ng/mL and clinical stage T1b-T2b (2002 AJCC.
- An enzymatic prostatic acid phosphatase must be obtained prior to implantation.
- No pelvic external beam radiation therapy for either prostate cancer or other malignancies.
- Androgen deprivation therapy less than 4 month duration for size reduction is allowable.
- No surgical staging for prostate cancer.
- A minimum of 5 year life expectancy.
- No other invasive cancer diagnosis other than non-melanoma skin cancer within the last 5 years.
Exclusion
- Exclusion criteria will be limited to patients who do not meet the above eligibility criteria.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT00247312
Start Date
October 1 2005
End Date
November 1 2015
Last Update
November 17 2015
Active Locations (2)
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1
Radiation Oncology 174 Department of Veterans Affairs
Seattle, Washington, United States, 98108-1597
2
Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003