Recruiting

Brachytherapy Techniques

Sponsor:

Massachusetts General Hospital

Code:

NCT00681694

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

brachytherapy

brachytherapy

brachytherapy

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT00681694

Start date

Mar, 2002

Status verified date

Apr, 2010

Completion date

Mar, 2011

Anticipated

Primary completion date

Mar, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

414 participants

Anticipated

Interventions and Outcome Measures

Arms

MRBT

MRI-assisted brachytherapy, the experimental arm

USBT1

Standard ultrasound-guided brachytherapy performed by group 1 (control arm 1)

USBT2

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

Interventions

brachytherapy

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

brachytherapy

Standard ultrasound-guided brachytherapy with standard target volumes

brachytherapy

Standard ultrasound-guided brachytherapy with standard target volumes

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

James Talcott, MD, SM

617-724-5451jtalcott@partners.org

Anita Rodrigues

aerodrigues@partners.org

Locations

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

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 28, 2010

Last verified

Apr, 2010

Keywords

  • brachytherapy
  • radioactive seed implants

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2010-04-28.