Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00241384
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2005-10-14
Brief Title:
Low Dose Supplemental External Radiation With Pd-103 Versus Pd-103 Alone for Prostate Cancer
Sponsor:
Schiffler Cancer Center
Organization:
Schiffler Cancer Center
Study Overview
Official Title:
Low Dose Supplemental External Radiation With PD-103 Versus PD-103 Alone For Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Approximately 250000 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 ngml 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None