NCT00494546

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
568

participants targeted

Target at P50-P75 for phase_3 prostate-cancer

Timeline
Completed

Started Jan 1999

Typical duration for phase_3 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
8.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2007

Completed
Last Updated

June 29, 2007

Status Verified

June 1, 2007

First QC Date

June 28, 2007

Last Update Submit

June 28, 2007

Conditions

Prostate Cancer

Keywords

prostatebrachytherapy

Outcome Measures

Primary Outcomes (1)

  • cancer control

    5-year post treatment

Secondary Outcomes (1)

  • rectal and urinary morbidity

    2- and 5-year

Interventions

Pd-103 with 20 vs 44 Gy supplemental beam XRTPROCEDURE

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Lymph nodes positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound

Seattle, Washington, 98108, United States

Location

Related 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 Oncol. 2005 Jun;75(3):307-10. doi: 10.1016/j.radonc.2005.03.019.

    PMID: 16086912RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Kent E Wallner, MD

    Puget Sound Health Care system

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

June 28, 2007

First Posted

June 29, 2007

Study Start

January 1, 1999

Study Completion

June 1, 2007

Last Updated

June 29, 2007

Record last verified: 2007-06

Locations

US(1)