Pd-103 Dose De-Escalation for Early Stage Prostate Cancer: A Prospective Randomized Trial
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Pd-103 Dose De-Escalation for Early Stage Prostate Cancer: A Prospective Randomized Trial|
- PSA determinations will be obtained 3 months following implantation and then every 6 months.
- Androgen deprivation therapy will not be initiated unless the PSA exceeds 10 ng/mL or distant metastases are detected.
- Following brachytherapy, I-PSS will be obtained on months 1, 3, 6, 12, 18, 24, 36, 48, 60.
- Following brachytherapy, R-FAS will be obtained on months 12, 36 and 60.
- Following brachytherapy, IIEF will be obtained on months 12, 36 and 60.
- Post implant quality of life evaluations will be forwarded to Dr. G. Merrick as appropriate.
|Study Start Date:||October 2005|
|Estimated Study Completion Date:||October 2008|
|Active Comparator: 125Gy prescription dose Pd-103||Radiation: Pd-103|
|Active Comparator: 110 Gy prescription dose Pd-103||Radiation: Pd-103|
Show Detailed Description
|Contact: Gregory S. Merrick, MDfirstname.lastname@example.org|
|United States, Washington|
|Radiation Oncology 174 Department of Veterans Affairs||Recruiting|
|Seattle, Washington, United States, 98108-1597|
|Contact: Kent E Wallner, MD 206-768-5356 email@example.com|
|United States, West Virginia|
|Schiffler Cancer Center||Recruiting|
|Wheeling, West Virginia, United States, 26003|
|Contact: Gregory S. Merrick, MD 304-243-3490 firstname.lastname@example.org|
|Contact: Robin Stipetich, RN, OCN 304-243-3490|
|Principal Investigator: Gregory S. Merrick, MD|
|Principal Investigator:||Gregory S. Merrick, MD||Schiffler Cancer Center, Wheeling, WV|
|Study Chair:||Kent E. Wallner, MD||Department of Veterans Affairs, Seattle, WA|