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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00494546
• Other study ID #: 2044
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2007
• Last updated: June 28, 2007
• Start date: January 1999
• Est. completion date: June 2007

Study information

• Verified date: June 2007
• Source: VA Puget Sound Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Males

• Prostate cancer

• PSA 10-20

• Gleason score 7-10

Exclusion Criteria:

• Lymph nodes positive

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Pd-103 with 20 vs 44 Gy supplemental beam XRT

Locations

Country	Name	City	State
United States	VA Puget Sound	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
VA Puget Sound Health Care System	Schiffler Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Onco — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cancer control		5-year post treatment
Secondary	rectal and urinary morbidity		2- and 5-year