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Low Dose Supplemental External Radiation With Pd-103 Versus Pd-103 Alone for Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
External beam radiation
Pd-103
Sponsored by
Schiffler Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostatic Cancer, Brachytherapy, Prostatic neoplasm, Radiation therapy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Veterans Administration Puget Sound Health Care System
  • Schiffler Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pd-103 with 20Gy External Beam

Pd-103 alone

Arm Description

Pd-103 with 20Gy External Beam

Pd-103 alone

Outcomes

Primary Outcome Measures

Serial PSA : 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
Post treatment biopsies in those with persistently elevated
PSA which is suggestive of residual tumor.
PSA which is suggestive of residual tumor.

Secondary Outcome Measures

Full Information

First Posted
October 14, 2005
Last Updated
November 16, 2015
Sponsor
Schiffler Cancer Center
Collaborators
Theragenics, University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00241384
Brief Title
Low Dose Supplemental External Radiation With Pd-103 Versus Pd-103 Alone for Prostate Cancer
Official Title
Low Dose Supplemental External Radiation With PD-103 Versus PD-103 Alone For Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schiffler Cancer Center
Collaborators
Theragenics, University of Washington

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostatic Cancer, Brachytherapy, Prostatic neoplasm, Radiation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
396 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pd-103 with 20Gy External Beam
Arm Type
Active Comparator
Arm Description
Pd-103 with 20Gy External Beam
Arm Title
Pd-103 alone
Arm Type
Active Comparator
Arm Description
Pd-103 alone
Intervention Type
Procedure
Intervention Name(s)
External beam radiation
Intervention Type
Procedure
Intervention Name(s)
Pd-103
Primary Outcome Measure Information:
Title
Serial PSA : 6, 12, 18 and 24 months and then yearly.
Description
Serial PSA : 6, 12, 18 and 24 months and then yearly.
Time Frame
6, 12, 18 and 24 months and then yearly
Title
Post treatment biopsies in those with persistently elevated
Description
Post treatment biopsies in those with persistently elevated
Time Frame
as needed
Title
PSA which is suggestive of residual tumor.
Description
PSA which is suggestive of residual tumor.
Time Frame
as needed

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory S Merrick, MD
Organizational Affiliation
Schiffler Cancer Center, Wheeling, WV
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kent E Wallner, MD
Organizational Affiliation
University of Washington VA Center
Official's Role
Study Chair
Facility Information:
Facility Name
Veterans Administration Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108-1597
Country
United States
Facility Name
Schiffler Cancer Center
City
Wheeling
State/Province
West Virginia
ZIP/Postal Code
26003
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15089421
Citation
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.
Results Reference
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PubMed Identifier
10705004
Citation
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.
Results Reference
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PubMed Identifier
10953137
Citation
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.
Results Reference
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PubMed Identifier
11516849
Citation
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.
Results Reference
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PubMed Identifier
10562177
Citation
Blue E. Letting go of Ben. Nurs Spectr (Wash D C). 1999 Mar 8;9(5):20. No abstract available.
Results Reference
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PubMed Identifier
11395226
Citation
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.
Results Reference
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Citation
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.
Results Reference
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Citation
Wallner K, Merrick G, Butler W, Sheretz T, Sutlief S, Cavanagh W, et al. 20 Gy versus 44 Gy supplemental beam radiation combined with Pd-103 prostate brachytherapy: early results from a prospective randomized multicenter trial (submitted)2004.
Results Reference
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PubMed Identifier
9054874
Citation
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.
Results Reference
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PubMed Identifier
8884970
Citation
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.
Results Reference
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Low Dose Supplemental External Radiation With Pd-103 Versus Pd-103 Alone for Prostate Cancer

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