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

June 28, 2007 updated by: VA Puget Sound Health Care System

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

568

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Lymph nodes positive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cancer control
Time Frame: 5-year post treatment
5-year post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
rectal and urinary morbidity
Time Frame: 2- and 5-year
2- and 5-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Puget Sound Health Care System

Collaborators

Schiffler Cancer Center

Investigators

  • Study Chair: Kent E Wallner, MD, Puget Sound Health Care system

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

June 28, 2007

First Submitted That Met QC Criteria

June 28, 2007

First Posted (Estimate)

June 29, 2007

Study Record Updates

Last Update Posted (Estimate)

June 29, 2007

Last Update Submitted That Met QC Criteria

June 28, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2044

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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