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Sponsors and Collaborators: |
Massachusetts General Hospital Dana-Farber Cancer Institute Brigham and Women's Hospital Beth Israel Deaconess Medical Center Metro West Medical Center Department of Defense |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00681694 |
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.
Condition | Intervention |
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Prostate Cancer |
Radiation: brachytherapy |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Long-Term Outcomes of Alternative Brachytherapy Techniques for Early Prostate Cancer |
Estimated Enrollment: | 414 |
Study Start Date: | March 2002 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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MRBT
MRI-assisted brachytherapy, the experimental arm
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Radiation: brachytherapy
An experimental arm using MRI imaging and excluding the transition zone from the target volume
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USBT1
Standard ultrasound-guided brachytherapy performed by group 1 (control arm 1)
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Radiation: brachytherapy
Standard ultrasound-guided brachytherapy with standard target volumes
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USBT2
Standard ultrasound-guided brachytherapy performed by group 2 (control group 2)
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Radiation: brachytherapy
Standard ultrasound-guided brachytherapy with standard target volumes
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients who have indicated their intention to receive brachytherapy at one of the four accrual sites.
Inclusion Criteria:
Exclusion Criteria:
Contact: James Talcott, MD, SM | 617-724-5451 | jtalcott@partners.org |
Contact: Anita Rodrigues | aerodrigues@partners.org |
United States, Massachusetts | |
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 |
Principal Investigator: | James Talcott, MD, SM | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( James Talcott, MD, SM ) |
Study ID Numbers: | 01-264 |
Study First Received: | May 19, 2008 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00681694 |
Health Authority: | United States: Institutional Review Board |
brachytherapy radioactive seed implants |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |