Long-Term Outcomes of Alternative Brachytherapy Techniques for Early Prostate Cancer

April 27, 2010 updated by: Massachusetts General Hospital
The purpose of this research study is to assess outcomes of treatment for early prostate cancer. Current treatments for early (non-metastatic) cancer may cause long-term impairments in the patients quality of life. In this study we will compare the outcomes of patients treated with two alternative brachytherapy (seed implants) techniques using a series of questionnaires.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Participants will be asked to complete a questionnaire about their health prior to treatment, at 1, 3 and 12 months after treatment and then once a year 4 more times.

Study Type

Observational

Enrollment (Anticipated)

414

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • James Talcott, MD, SM
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Irving Kaplan, MD
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Dana-Farber Cancer Institute/Brigham and Women's Hospital
        • Principal Investigator:
          • Anthony D'Amico, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients who have indicated their intention to receive brachytherapy at one of the four accrual sites.

Description

Inclusion Criteria:

  • Pathological diagnosis of an adenocarcinoma of the prostate
  • 18 years of age or older
  • Prior choice of either standard brachytherapy or MRIGPB as primary treatment

Exclusion Criteria:

  • Prior primary therapy (surgery or external beam radiation) for prostate cancer
  • Current hormone ablation therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MRBT
MRI-assisted brachytherapy, the experimental arm
Radiation: brachytherapy
An experimental arm using MRI imaging and excluding the transition zone from the target volume
Radiation: brachytherapy
Standard ultrasound-guided brachytherapy with standard target volumes
USBT1
Standard ultrasound-guided brachytherapy performed by group 1 (control arm 1)
Radiation: brachytherapy
An experimental arm using MRI imaging and excluding the transition zone from the target volume
Radiation: brachytherapy
Standard ultrasound-guided brachytherapy with standard target volumes
USBT2
Standard ultrasound-guided brachytherapy performed by group 2 (control group 2)
Radiation: brachytherapy
An experimental arm using MRI imaging and excluding the transition zone from the target volume
Radiation: brachytherapy
Standard ultrasound-guided brachytherapy with standard target volumes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess changes in generic and disease specific quality of life over time after treatment with brachytherapy for early prostate cancer
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare these outcomes after two alternative brachytherapy techniques, standard ultrasound guided brachytherapy and MRI guided prostate brachytherapy (MRIGPB)
Time Frame: 10 years
10 years
To identify factors associated with specific adverse outcomes.
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
United States Department of Defense
Brigham and Women's Hospital
Metro West Medical Center

Investigators

  • Principal Investigator: James Talcott, MD, SM, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Anticipated)

March 1, 2011

Study Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

May 19, 2008

First Submitted That Met QC Criteria

May 20, 2008

First Posted (Estimate)

May 21, 2008

Study Record Updates

Last Update Posted (Estimate)

April 28, 2010

Last Update Submitted That Met QC Criteria

April 27, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-264

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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