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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00681694
• Other study ID #: 01-264
• Status: Recruiting
• Phase: N/A
• First received: May 19, 2008
• Last updated: April 27, 2010
• Start date: March 2002
• Est. completion date: March 2011

Study information

• Verified date: April 2010
• Source: Massachusetts General Hospital
• Contact: James Talcott, MD, SM
• Phone: 617-724-5451
• Email: jtalcott[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 414
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute/Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Metro West Medical Center, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess changes in generic and disease specific quality of life over time after treatment with brachytherapy for early prostate cancer		10 years	No
Secondary	To compare these outcomes after two alternative brachytherapy techniques, standard ultrasound guided brachytherapy and MRI guided prostate brachytherapy (MRIGPB)		10 years	No
Secondary	To identify factors associated with specific adverse outcomes.		10 years	No