Low Dose Supplemental External Radiation With PD-103 Versus PD-103 Alone For Prostate Cancer
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Serial PSA : 6, 12, 18 and 24 months and then yearly.
Serial PSA : 6, 12, 18 and 24 months and then yearly.
6, 12, 18 and 24 months and then yearly
No
Gregory S Merrick, MD
Principal Investigator
Schiffler Cancer Center, Wheeling, WV
United States: Institutional Review Board
04-8-10
NCT00241384
January 2005
December 2013
Name | Location |
---|---|
Schiffler Cancer Center | Wheeling, West Virginia 26003 |
Veterans Administration Puget Sound Health Care System | Seattle, Washington 98108-1597 |