Pd-103 Dose De-Escalation for Early Stage Prostate Cancer: A Prospective Randomized Trial
NCT00247312 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 319
Last updated 2015-11-17
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 appears that the prescribed radiation dose can be reduced by 14-20% without any difference in potential cure (in this study, the dose is being decreased 10%). Although most patients tolerate brachytherapy well, complications to appear to be related to radiation exposure to normal structures (i.e. urethra, rectum and proximal penis). By reducing the prescribed dose, it is conceivable that fewer patients will experience side effects and complications.
Conditions
- Prostatic Neoplasm
Interventions
- RADIATION
-
Pd-103
Sponsors & Collaborators
-
Schiffler Cancer Center
lead OTHER
Principal Investigators
-
Gregory S. Merrick, MD · Schiffler Cancer Center, Wheeling, WV
-
Kent E. Wallner, MD · Department of Veterans Affairs, Seattle, WA
Study Design
- Allocation
- RANDOMIZED
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2005-10-31
- Primary Completion
- 2015-11-30
- Completion
- 2015-11-30
Countries
- United States
Study Locations
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