High Versus Low Dose Supplemental External Radiation With Pd-103 for Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Pd-103 with 20 vs 44 Gy supplemental beam XRT
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate, brachytherapy
Eligibility Criteria
Inclusion Criteria:
- Males
- Prostate cancer
- PSA 10-20
- Gleason score 7-10
Exclusion Criteria:
- Lymph nodes positive
Sites / Locations
- VA Puget Sound
Outcomes
Primary Outcome Measures
cancer control
Secondary Outcome Measures
rectal and urinary morbidity
Full Information
NCT ID
NCT00494546
First Posted
June 28, 2007
Last Updated
June 28, 2007
Sponsor
VA Puget Sound Health Care System
Collaborators
Schiffler Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00494546
Brief Title
High Versus Low Dose Supplemental External Radiation With Pd-103 for Prostate Cancer
Official Title
High Versus Low Dose Supplemental External Radiation With Pd-103 for Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
VA Puget Sound Health Care System
Collaborators
Schiffler Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objective: The objective of this study is test the hypothesis that delivering a higher percentage of the radiation dose as external radiation versus implant will lead to higher tumor control rates.
Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma (Gleason grade 7 to 10 and/or PSA 10 to 20 ng/ml) will be randomized to treatment with 44 Gy versus 20 Gy external radiation plus a Pd-103 implant boost (90 Gy versus 105 Gy, respectively).
Detailed Description
Objective: The objective of this study is test the hypothesis that delivering a higher percentage of the radiation dose as external radiation versus implant will lead to higher tumor control rates.
Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma (Gleason grade 7 to 10 and/or PSA 10 to 20 ng/ml) will be randomized to treatment with 44 Gy versus 20 Gy external radiation plus a Pd-103 implant boost (90 Gy versus 105 Gy, respectively).
Methodology: Patients will be randomized by the method of random permuted blocks.
Cancer status will be monitored by serial serum PSA at 6, 12, 18 and 24 months and yearly thereafter. Treatment-related morbidity will be monitored by personal interview, using standard American Urologic Association and Radiation Therapy Oncology Group criteria at 1, 3, 6, 12 and 24 months. The primary endpoint will be based on serum PSA. A value above 1.0 ng/ml two years after treatment will be considered to have residual or recurrent cancer and to have failed therapy.
Findings: 566 patients have been randomized and the study was closed due to slowing accrual. A preliminary analysis shows similar morbidity between the treatment arms, and nearly identical cancer control rates between randomization arms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate, brachytherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
568 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Pd-103 with 20 vs 44 Gy supplemental beam XRT
Primary Outcome Measure Information:
Title
cancer control
Time Frame
5-year post treatment
Secondary Outcome Measure Information:
Title
rectal and urinary morbidity
Time Frame
2- and 5-year
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:
Males
Prostate cancer
PSA 10-20
Gleason score 7-10
Exclusion Criteria:
Lymph nodes positive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent E Wallner, MD
Organizational Affiliation
Puget Sound Health Care system
Official's Role
Study Chair
Facility Information:
Facility Name
VA Puget Sound
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16086912
Citation
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.
Results Reference
result
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High Versus Low Dose Supplemental External Radiation With Pd-103 for Prostate Cancer
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