Long-Term Outcomes of Alternative Brachytherapy Techniques for Early Prostate Cancer
1 other identifier
observational
414
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2002
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 19, 2008
CompletedFirst Posted
Study publicly available on registry
May 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedApril 28, 2010
April 1, 2010
9 years
May 19, 2008
April 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess changes in generic and disease specific quality of life over time after treatment with brachytherapy for early prostate cancer
10 years
Secondary Outcomes (2)
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
Study Arms (3)
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
An experimental arm using MRI imaging and excluding the transition zone from the target volume
Eligibility Criteria
Patients who have indicated their intention to receive brachytherapy at one of the four accrual sites.
You may qualify if:
- Pathological diagnosis of an adenocarcinoma of the prostate
- years of age or older
- Prior choice of either standard brachytherapy or MRIGPB as primary treatment
You may not qualify if:
- Prior primary therapy (surgery or external beam radiation) for prostate cancer
- Current hormone ablation therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Dana-Farber Cancer Institutecollaborator
- Brigham and Women's Hospitalcollaborator
- Beth Israel Deaconess Medical Centercollaborator
- Metro West Medical Centercollaborator
- United States Department of Defensecollaborator
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute/Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Talcott, MD, SM
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 19, 2008
First Posted
May 21, 2008
Study Start
March 1, 2002
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
April 28, 2010
Record last verified: 2010-04