NCT00494039

Brief Summary

Objective: To test the hypothesis that the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication. Research design A total of 600 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 2 to 6, PSA 4 to 10 ng/ml) will be randomized to implantation with I-125 (160 Gy) versus Pd-103 (115 Gy).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
602

participants targeted

Target at P50-P75 for phase_3 prostate-cancer

Timeline
Completed

Started Jan 1998

Longer than P75 for phase_3 prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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, 1998

Completed
9.5 years 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
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

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

prostatecancerradiationbrachytherapy

Outcome Measures

Primary Outcomes (1)

  • Cancer control (biochemical and survival)

    final analysis 2008(?)

Interventions

Radioactive seed implant to prostatePROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Males age 40-80
  • PSA 4-10
  • Gleason score 5-6

You may not qualify if:

  • Lymph node positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Puget Sound VA

Seattle, Washington, 98108, United States

Location

Related Publications (2)

  • Wallner K, Merrick G, True L, Sutlief S, Cavanagh W, Butler W. 125I versus 103Pd for low-risk prostate cancer: preliminary PSA outcomes from a prospective randomized multicenter trial. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1297-303. doi: 10.1016/s0360-3016(03)01448-2.

    PMID: 14630265RESULT

  • Wallner K, Merrick G, True L, Cavanagh W, Simpson C, Butler W. I-125 versus Pd-103 for low-risk prostate cancer: morbidity outcomes from a prospective randomized multicenter trial. Cancer J. 2002 Jan-Feb;8(1):67-73. doi: 10.1097/00130404-200201000-00012.

    PMID: 11895205RESULT

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital 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, 1998

Study Completion

January 1, 2010

Last Updated

June 29, 2007

Record last verified: 2007-06

Locations

US(1)