NCT01810627

Brief Summary

This is a non-randomized study to evaluate the utility of MVCT as a quality assurance measure in patients treated with interstitial permanent seed implants for low and intermediate risk prostate cancer. All patients will received the same standard of care treatment but will receive an additinoal CT image of the prostate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

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

First Submitted

Initial submission to the registry

March 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

2.6 years

First QC Date

March 11, 2013

Last Update Submit

September 22, 2017

Conditions

Prostate Cancer

Keywords

ProstateCancer

Outcome Measures

Primary Outcomes (1)

  • Change in prostate volume measured in cm^3

    Change in prostate volume measured with trans-rectal ultrasound at baseline versus prostate volume measured with KVCT and MVCT.

    One month post implant

Study Arms (1)

MVCT

Patients will receive an additional MVCT scan at their one month follow up visit.

Radiation: MVCT

Interventions

MVCTRADIATION

Patients will receive an additional MVCT scan at their one month follow up visit.

MVCT

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male 50-80 years of age Eligible for interstitial brachytherapy implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • William St. Clair, MD

    Lucille P. Markey Cancer Center at University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Faculty, Radiation Medicine

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 13, 2013

Study Start

September 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

September 26, 2017

Record last verified: 2017-09

Locations

US(1)