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

This study has been completed.
Sponsor:
Collaborator:
Schiffler Cancer Center
Information provided by:
VA Puget Sound Health Care System
ClinicalTrials.gov Identifier:
NCT00494546
First received: June 28, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Prostate Cancer
Procedure: Pd-103 with 20 vs 44 Gy supplemental beam XRT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Versus Low Dose Supplemental External Radiation With Pd-103 for Prostate Cancer

Resource links provided by NLM:


Further study details as provided by VA Puget Sound Health Care System:

Primary Outcome Measures:
  • cancer control [ Time Frame: 5-year post treatment ]

Secondary Outcome Measures:
  • rectal and urinary morbidity [ Time Frame: 2- and 5-year ]

Enrollment: 568
Study Start Date: January 1999
Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males
  • Prostate cancer
  • PSA 10-20
  • Gleason score 7-10

Exclusion Criteria:

  • Lymph nodes positive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494546

Locations
United States, Washington
VA Puget Sound
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Puget Sound Health Care System
Schiffler Cancer Center
Investigators
Study Chair: Kent E Wallner, MD Puget Sound Health Care system
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00494546     History of Changes
Other Study ID Numbers: 2044
Study First Received: June 28, 2007
Last Updated: June 28, 2007
Health Authority: United States: Federal Government

Keywords provided by VA Puget Sound Health Care System:
prostate
brachytherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 15, 2014