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

This study is currently recruiting participants.

Verified by Massachusetts General Hospital, August 2009

First Received: May 19, 2008 Last Updated: August 7, 2009 History of Changes

Sponsor:	Massachusetts General Hospital
Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Beth Israel Deaconess Medical Center Metro West Medical Center Department of Defense
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00681694

Purpose

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.

Condition	Intervention
Prostate Cancer	Radiation: brachytherapy

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Long-Term Outcomes of Alternative Brachytherapy Techniques for Early Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare these outcomes after two alternative brachytherapy techniques, standard ultrasound guided brachytherapy and MRI guided prostate brachytherapy (MRIGPB) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
To identify factors associated with specific adverse outcomes. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	414
Study Start Date:	March 2002
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681694

Contacts

Contact: James Talcott, MD, SM	617-724-5451	jtalcott@partners.org
Contact: Anita Rodrigues		aerodrigues@partners.org

Locations

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

Sponsors and Collaborators

Massachusetts General Hospital

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Metro West Medical Center

Department of Defense

Investigators

Principal Investigator:

James Talcott, MD, SM

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Massachusetts General Hospital ( James Talcott, MD, SM )
Study ID Numbers:	01-264
Study First Received:	May 19, 2008
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00681694 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

brachytherapy
radioactive seed implants

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010