Low Dose Supplemental External Radiation With Pd-103 Versus Pd-103 Alone for Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00241384|
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : November 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: External beam radiation Procedure: Pd-103||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||396 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Low Dose Supplemental External Radiation With PD-103 Versus PD-103 Alone For Prostate Cancer|
|Study Start Date :||January 2005|
|Primary Completion Date :||November 2015|
|Study Completion Date :||November 2015|
Active Comparator: Pd-103 with 20Gy External Beam
Pd-103 with 20Gy External Beam
|Procedure: External beam radiation|
Active Comparator: Pd-103 alone
- Serial PSA : 6, 12, 18 and 24 months and then yearly. [ Time Frame: 6, 12, 18 and 24 months and then yearly ]Serial PSA : 6, 12, 18 and 24 months and then yearly.
- Post treatment biopsies in those with persistently elevated [ Time Frame: as needed ]Post treatment biopsies in those with persistently elevated
- PSA which is suggestive of residual tumor. [ Time Frame: as needed ]PSA which is suggestive of residual tumor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241384
|United States, Washington|
|Veterans Administration Puget Sound Health Care System|
|Seattle, Washington, United States, 98108-1597|
|United States, West Virginia|
|Schiffler Cancer Center|
|Wheeling, West Virginia, United States, 26003|
|Principal Investigator:||Gregory S Merrick, MD||Schiffler Cancer Center, Wheeling, WV|
|Study Chair:||Kent E Wallner, MD||University of Washington VA Center|