NCT00348465

Brief Summary

The size of the prostate changes due to insertion of the radioactive seeds. We will measure the prostate size, before and after the procedure.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2006

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

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

1.6 years

First QC Date

July 3, 2006

Last Update Submit

September 16, 2020

Conditions

Prostate Cancer

Keywords

BrachytherapyProstate volume

Interventions

Brachytherapy with Iodine-125 seedsPROCEDURE

Brachytherapy of the prostate, and measurements of the prostate volume using CT scan and TURS

Also known as: Prostate Volume over time

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prostate Cancer patients

You may qualify if:

  • Pathologically confirmed diagnosis of prostate cancer
  • T1-3 disease
  • PSA \<20 ng/ml
  • Patient must sign a study-specific informed consent prior to enrollment.

You may not qualify if:

  • Patients ineligible to brachytherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

  • Hani Ashamalla, MD, FCCP

    New York Presbyterian Brooklyn Methodist Hospital

    STUDY CHAIR

  • Ewa Bieniek, MD

    NY Methodist Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

May 1, 2006

Primary Completion

December 1, 2007

Study Completion

March 1, 2008

Last Updated

September 18, 2020

Record last verified: 2020-09