Low Dose Supplemental External Radiation With Pd-103 Versus Pd-103 Alone for Prostate Cancer
The primary purpose of this study is to evaluate two treatment regimens for prostate cancer, prostate implant with 20 Gy of external beam radiation therapy versus prostate implant with 0 Gy of external beam radiation therapy. Patients diagnosed with intermediate risk prostate cancer between the ages of 40 and 80 who have chosen brachytherapy with or without external beam radiation therapy as their intended treatment will be eligible and will be offered participation.
Procedure: External beam radiation
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Low Dose Supplemental External Radiation With PD-103 Versus PD-103 Alone For Prostate Cancer|
- Serial PSA : 6, 12, 18 and 24 months and then yearly. [ Time Frame: 6, 12, 18 and 24 months and then yearly ] [ Designated as safety issue: No ]Serial PSA : 6, 12, 18 and 24 months and then yearly.
- Post treatment biopsies in those with persistently elevated [ Time Frame: as needed ] [ Designated as safety issue: No ]Post treatment biopsies in those with persistently elevated
- PSA which is suggestive of residual tumor. [ Time Frame: as needed ] [ Designated as safety issue: No ]PSA which is suggestive of residual tumor.
|Study Start Date:||January 2005|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Pd-103 with 20Gy External Beam
Pd-103 with 20Gy External Beam
|Procedure: External beam radiation|
Active Comparator: Pd-103 alone
Approximately 250,000 men are currently diagnosed with prostatic cancer in the United States each year. Of those, 70% have stage T1 or T2 disease (apparently limited to the prostate gland). Clinically localized prostate cancer is a spectrum of disease, ranging from good prognosis to poor prognosis. Patients with a PSA above 10 ng/ml or Gleason score of 7 to 10 are referred to as intermediate risk, with approximately an 80% chance of cure.
Implantation of radioactive sources directly into the prostate (brachytherapy) delivers a high, localized radiation dose while sparing most the of the bladder and rectum. Brachytherapy is well established for other tumor sites, and has become a standard treatment for prostate cancer.
Establishing that a good quality implant alone is as effective as implant plus beam radiation will allow us to routinely drop the use of beam radiation, a change in policy that will decrease the risk of some complications, will be more convenient for patients, and will lower treatment costs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241384
|Contact: Gregory S Merrick, MDfirstname.lastname@example.org|
|Contact: Kent E Wallner, MD||206-768-5356||Kent.Wallner@med.va.gov|
|United States, Washington|
|Veterans Administration Puget Sound Health Care System||Recruiting|
|Seattle, Washington, United States, 98108-1597|
|Contact: Kent E Wallner, MD 206-768-5356 Kent.Wallner@med.va.gov|
|United States, West Virginia|
|Schiffler Cancer Center||Recruiting|
|Wheeling, West Virginia, United States, 26003|
|Contact: Gregory S Merrick, MD 304-243-3490 email@example.com|
|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||University of Washington VA Center|