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

NCT ID: NCT00681694

Last Updated: 2010-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

414 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-03-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MRBT

MRI-assisted brachytherapy, the experimental arm

brachytherapy

Intervention Type RADIATION

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)

brachytherapy

Intervention Type RADIATION

Standard ultrasound-guided brachytherapy with standard target volumes

USBT2

Standard ultrasound-guided brachytherapy performed by group 2 (control group 2)

brachytherapy

Intervention Type RADIATION

Standard ultrasound-guided brachytherapy with standard target volumes

Interventions

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brachytherapy

An experimental arm using MRI imaging and excluding the transition zone from the target volume

Intervention Type RADIATION

brachytherapy

Standard ultrasound-guided brachytherapy with standard target volumes

Intervention Type RADIATION

brachytherapy

Standard ultrasound-guided brachytherapy with standard target volumes

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role collaborator

Metro West Medical Center

OTHER

Sponsor Role collaborator

United States Department of Defense

FED

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Massachusetts General Hospital

Principal Investigators

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James Talcott, MD, SM

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Dana-Farber Cancer Institute/Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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James Talcott, MD, SM

Role: CONTACT

617-724-5451

Anita Rodrigues

Role: CONTACT

Other Identifiers

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01-264

Identifier Type: -

Identifier Source: org_study_id

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