NCT00486499

Brief Summary

hypothesis: the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication. A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7 to 9 and/or PSA 10-20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus Pd-103 (124 Gy).

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
660

participants targeted

Target at P50-P75 for phase_3 prostate-cancer

Geographic Reach
1 country

2 active sites

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

March 1, 2003

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2007

Completed
Last Updated

June 14, 2007

Status Verified

June 1, 2007

First QC Date

June 12, 2007

Last Update Submit

June 12, 2007

Conditions

Prostate Cancer

Keywords

radiationbrachytherapyprostatecancer

Outcome Measures

Primary Outcomes (1)

  • PSA-based cancer eradication

Interventions

I-125 versus Pd-103 radioactive seed insertionPROCEDURE

Eligibility Criteria

Age40 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PSA 4-10 ng/ml
  • Gleason score 5 or 6

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Group Health Cooperative

Seattle, Washington, 98104, United States

RECRUITING

VA Puget Sound

Seattle, Washington, 98108, United States

RECRUITING

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

    VA Puget Sound, Group Health Cooperative, U of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

kent E Wallner, md

CONTACT

206-768-5356kent.wallner@med.va.gov

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 12, 2007

First Posted

June 14, 2007

Study Start

March 1, 2003

Last Updated

June 14, 2007

Record last verified: 2007-06

Locations

US(2)