NCT01913197

Brief Summary

In standard prostate brachytherapy treatment, the seeds are placed throughout the prostate to treat the entire gland. This is done because, in the past, it was impossible to know where the cancer was located within the prostate. Multiparametric magnetic resonance imaging (MRI) can identify tumor(s) with a high degree of accuracy. This trial will assess whether using MRI to guide prostate brachytherapy can result in less chronic toxicity by allowing lower doses to be delivered to the regions of the prostate without tumor while simultaneously allowing higher doses to the tumor. Subjects enrolled in this study will then be followed over two years and evaluated for toxicity. In addition, after two years they will undergo an MRI and a biopsy to assess the cancer control rate of the treatment.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_1 prostate-cancer

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

July 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

3.3 years

First QC Date

July 29, 2013

Last Update Submit

January 5, 2017

Conditions

Prostate Cancer

Keywords

Prostate Brachytherapy

Outcome Measures

Primary Outcomes (1)

  • Chronic toxicity as assessed by the Common Toxicity Criteria Version 4.0

    2 years

Study Arms (1)

Pre-implant MRI images and planning

EXPERIMENTAL
Other: An MRI-based technique to identify prostate cancer

Interventions

An MRI-based technique to identify prostate cancerOTHER
Pre-implant MRI images and planning

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical stage ≤ T2b according to the American Joint Commission on Cancer 6th Edition28
  • PSA ≤ 15 ng/ml
  • Gleason sum on biopsy ≤ 6 or 3+4=7
  • Prostate volume ≤ 60 cc
  • Willing to continue follow-up for at least two years

You may not qualify if:

  • Prior hormone therapy
  • Prior radiotherapy
  • History of collagen vascular disease
  • History of inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Lukes-Roosevelt Hospital Center

New York, New York, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ronald Ennis, MD

    St. Luke's-Roosevelt Hospital Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2013

First Posted

July 31, 2013

Study Start

August 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

US(1)