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

• Conditions: Prostate Cancer
• Interventions: Radiation: brachytherapy

• Registration Number: NCT00681694
• Lead Sponsor: Massachusetts General Hospital

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.

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 Timeline

• Study Start: 2002-03
• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-21
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-27
• Last Update Posted: 2010-04-28
• Primary Completion: 2011-03
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 414

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
USBT2	brachytherapy	Standard ultrasound-guided brachytherapy performed by group 2 (control group 2)
MRBT	brachytherapy	MRI-assisted brachytherapy, the experimental arm
USBT1	brachytherapy	Standard ultrasound-guided brachytherapy performed by group 1 (control arm 1)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute/Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States