Pd-103 Dose De-Escalation for Early Stage Prostate Cancer: A Prospective Randomized Trial
Completed · Phase 3
Conditions studied: Prostatic Neoplasm
In brief
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.
Key facts
- Study ID
- NCT00247312
- Run by
- Schiffler Cancer Center
- People needed
- 319
- Starts
- 2005-10-01
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2015-11-17
Who can join
Age: any. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- Exclusion criteria will be limited to patients who do not meet the above eligibility criteria.
Where it is running
- Radiation Oncology 174 Department of Veterans Affairs — Seattle, Washington, United States
- Schiffler Cancer Center — Wheeling, West Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.