Prostate Volume Changes Following Prostate Brachytherapy... | NCT00348465

Studies
Prostate Volume Changes Following Prostate Brachytherapy With Iodine-125 Seeds

NCT00348465

Sponsor

New York Presbyterian Brooklyn Methodist Hospital

Status

Completed

Last Update Posted

Sep 18, 2020Actual

Enrollment

29Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Brachytherapy with Iodine-125 seeds

Countries

Not provided

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

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006Actual

Primary Completion Date

Dec 2007Actual

Completion Date

Mar 2008Actual

First Submitted Date

Jul 3, 2006

First Submission Date that Met QC Criteria

Jul 3, 2006

First Posted Date

Jul 4, 2006Estimated

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

Sep 16, 2020

Last Update Posted Date

Sep 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hani Ashamalla, MD, MD, New York Presbyterian Brooklyn Methodist HospitalPrincipal Investigator

Lead Sponsor

New York Presbyterian Brooklyn Methodist HospitalOTHER

Collaborators

Not provided

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 size of the prostate changes due to insertion of the radioactive seeds. We will measure the prostate size, before and after the procedure.

Detailed Description

The prostate size will be measured using the TRUS and CT scan on days -1, 0, 1, 9, 30, and 60 days after the brachytherapy procedure.

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

29Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brachytherapy with Iodine-125 seeds	Procedure	Brachytherapy of the prostate, and measurements of the prostate volume using CT scan and TURS		Prostate Volume over time

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathologically confirmed diagnosis of prostate cancer
T1-3 disease
PSA <20 ng/ml
Patient must sign a study-specific informed consent prior to enrollment.

Exclusion Criteria:

Patients ineligible to brachytherapy

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Prostate Cancer patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hani Ashamalla, MD, FCCP	New York Presbyterian Brooklyn Methodist Hospital	Study Chair
Ewa Bieniek, MD	NY Methodist Hospital	Principal Investigator

Locations

Not provided

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