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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Metro West Medical Center
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00681694
First received: May 19, 2008
Last updated: April 27, 2010
Last verified: April 2010
  Purpose

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
Prostate Cancer
Radiation: brachytherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Outcomes of Alternative Brachytherapy Techniques for Early Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare these outcomes after two alternative brachytherapy techniques, standard ultrasound guided brachytherapy and MRI guided prostate brachytherapy (MRIGPB) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • To identify factors associated with specific adverse outcomes. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 414
Study Start Date: March 2002
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MRBT
MRI-assisted brachytherapy, the experimental arm
Radiation: brachytherapy
An experimental arm using MRI imaging and excluding the transition zone from the target volume
USBT1
Standard ultrasound-guided brachytherapy performed by group 1 (control arm 1)
Radiation: brachytherapy
Standard ultrasound-guided brachytherapy with standard target volumes
USBT2
Standard ultrasound-guided brachytherapy performed by group 2 (control group 2)
Radiation: brachytherapy
Standard ultrasound-guided brachytherapy with standard target volumes

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have indicated their intention to receive brachytherapy at one of the four accrual sites.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681694

Contacts
Contact: James Talcott, MD, SM 617-724-5451 jtalcott@partners.org
Contact: Anita Rodrigues aerodrigues@partners.org

Locations
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         
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Metro West Medical Center
Investigators
Principal Investigator: James Talcott, MD, SM Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: James Talcott, MD, SM, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00681694     History of Changes
Other Study ID Numbers: 01-264
Study First Received: May 19, 2008
Last Updated: April 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
brachytherapy
radioactive seed implants

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 26, 2014