- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00241384
Low Dose Supplemental External Radiation With Pd-103 Versus Pd-103 Alone for Prostate Cancer
Low Dose Supplemental External Radiation With PD-103 Versus PD-103 Alone For Prostate Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98108-1597
- Veterans Administration Puget Sound Health Care System
-
-
West Virginia
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Wheeling, West Virginia, United States, 26003
- Schiffler Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with previously untreated prostatic cancer.
- Must have PSA 10-20 ng/ml, Gleason 7 to 9
Exclusion Criteria:
- Patients with proven regional lymph node involvement will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pd-103 with 20Gy External Beam
|
|
Active Comparator: Pd-103 alone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
|
as needed
|
PSA which is suggestive of residual tumor.
Time Frame: as needed
|
PSA which is suggestive of residual tumor.
|
as needed
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gregory S Merrick, MD, Schiffler Cancer Center, Wheeling, WV
- Study Chair: Kent E Wallner, MD, University of Washington VA Center
Publications and helpful links
General Publications
- Potters L, Cao Y, Calugaru E, Torre T, Fearn P, Wang XH. A comprehensive review of CT-based dosimetry parameters and biochemical control in patients treated with permanent prostate brachytherapy. Int J Radiat Oncol Biol Phys. 2001 Jul 1;50(3):605-14. doi: 10.1016/s0360-3016(01)01473-0.
- Bartolini R, Dattoli G, Giannessi L, Mezi L, Renieri A, Migliorati M, Bruni C, Couprie ME, Garzella D, Orlandi G. Saturation and electron-beam lifetime in a storage ring free-electron laser. Phys Rev E Stat Nonlin Soft Matter Phys. 2004 Mar;69(3 Pt 2):036501. doi: 10.1103/PhysRevE.69.036501. Epub 2004 Mar 4.
- Blasko JC, Grimm PD, Sylvester JE, Badiozamani KR, Hoak D, Cavanagh W. Palladium-103 brachytherapy for prostate carcinoma. Int J Radiat Oncol Biol Phys. 2000 Mar 1;46(4):839-50. doi: 10.1016/s0360-3016(99)00499-x.
- Critz FA, Williams WH, Levinson AK, Benton JB, Holladay CT, Schnell FJ Jr. Simultaneous irradiation for prostate cancer: intermediate results with modern techniques. J Urol. 2000 Sep;164(3 Pt 1):738-41; discussion 741-3. doi: 10.1097/00005392-200009010-00028.
- Merrick GS, Butler WM, Galbreath RW, Lief JH. Five-year biochemical outcome following permanent interstitial brachytherapy for clinical T1-T3 prostate cancer. Int J Radiat Oncol Biol Phys. 2001 Sep 1;51(1):41-8. doi: 10.1016/s0360-3016(01)01594-2.
- Blue E. Letting go of Ben. Nurs Spectr (Wash D C). 1999 Mar 8;9(5):20. No abstract available.
- Blasko JC, Ragde H, Schumacher D. Transperineal percutaneous iodine-125 implantatio for prostatic carcinoma using transrectal ultrasound and template guidance. Endo/Hypertherm 1987;3:131-39.
- Wallner K, Merrick G, True L, Sherertz T, Sutlief S, Cavanagh W, Butler W. 20 Gy versus 44 Gy supplemental beam radiation with Pd-103 prostate brachytherapy: preliminary biochemical outcomes from a prospective randomized multi-center trial. Radiother Oncol. 2005 Jun;75(3):307-10. doi: 10.1016/j.radonc.2005.03.019.
- Prestidge BR, Hoak DC, Grimm PD, Ragde H, Cavanagh W, Blasko JC. Posttreatment biopsy results following interstitial brachytherapy in early-stage prostate cancer. Int J Radiat Oncol Biol Phys. 1997 Jan 1;37(1):31-9. doi: 10.1016/s0360-3016(96)00390-2.
- Zietman AL, Tibbs MK, Dallow KC, Smith CT, Althausen AF, Zlotecki RA, Shipley WU. Use of PSA nadir to predict subsequent biochemical outcome following external beam radiation therapy for T1-2 adenocarcinoma of the prostate. Radiother Oncol. 1996 Aug;40(2):159-62. doi: 10.1016/0167-8140(96)01770-7.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-8-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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