Long-Term Outcomes of Alternative Brachytherapy Technique... | NCT00681694

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

NCT00681694

Sponsor

Massachusetts General Hospital

Status

Unknown status

Last Update Posted

Apr 28, 2010Estimated

Enrollment

414Estimated

Phase

Not provided

Conditions

Prostate Cancer

Interventions

brachytherapy
brachytherapy
brachytherapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2002

Primary Completion Date

Mar 2011Estimated

Completion Date

Mar 2011Estimated

First Submitted Date

May 19, 2008

First Submission Date that Met QC Criteria

May 20, 2008

First Posted Date

May 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2010

Last Update Posted Date

Apr 28, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
Dana-Farber Cancer Institute	OTHER
Brigham and Women's Hospital	OTHER
Beth Israel Deaconess Medical Center	OTHER
Metro West Medical Center

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

414Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
brachytherapy	Radiation	An experimental arm using MRI imaging and excluding the transition zone from the target volume	MRBT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
James Talcott, MD, SM	Contact	617-724-5451		jtalcott@partners.org
Anita Rodrigues	Contact			aerodrigues@partners.org

Overall Officials

Name	Affiliation	Role
James Talcott, MD, SM	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital	Recruiting	Boston	Massachusetts	02114	United States

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001918	Brachytherapy

Ancestor Terms

ID	Term
D011878	Radiotherapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided