Comparison of Between ThinSeed™ and OncoSeed™ for Permane... | NCT01379742

Studies
Comparison of Between ThinSeed™ and OncoSeed™ for Permanent Prostate Brachytherapy

NCT01379742

Sponsor

Prostate Cancer Foundation of Chicago

Status

Unknown status

Last Update Posted

Feb 13, 2013Estimated

Enrollment

240Estimated

Phase

Phase 4

Conditions

Prostate Cancer

Interventions

RapidStrand seeds for use with 18g needle
ThinStrand

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

Feb 2013

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

Apr 2010

Primary Completion Date

Feb 2013Actual

Completion Date

Not provided

First Submitted Date

Jun 20, 2011

First Submission Date that Met QC Criteria

Jun 22, 2011

First Posted Date

Jun 23, 2011Estimated

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

Feb 11, 2013

Last Update Posted Date

Feb 13, 2013Estimated

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

This study will investigate health related quality of life factors in patients undergoing low dose rate prostate brachytherapy. Patients will be randomized to Iodine-125 Thinstrand (for use with 20 g needles) or Rapidstrand (for use with standard 18 g needles). Urinary, bowel, sexual function and bother will be measured by the EPIC questionnaire at various time intervals.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Iodine-125 standard 18 g needle	Active Comparator	Rapidstrand	Device: RapidStrand seeds for use with 18g needle Device: ThinStrand
20 g needle	Active Comparator	Thin Strand	Device: RapidStrand seeds for use with 18g needle Device: ThinStrand

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RapidStrand seeds for use with 18g needle	Device	Rapidstrand seeds are standard size and are used with 20 g needles	20 g needle Iodine-125 standard 18 g needle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire	Randomized	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate, clinical stage T1c - T2b, N0, M0
Greater than or equal to 40 years of age
Low and Low- Intermediate Risk prostate cancer
Prostate volumes by TRUS ≤ 60 cc
I-PSS score < 25 (alpha blockers allowed)
Signed study-specific informed consent form prior to study entry

Exclusion Criteria:

Lymph node involvement (N1)
Evidence of distant metastases (M1)
Radical surgery for carcinoma of the prostate
Prior pelvic radiation
Major medical or psychiatric illness, which in the investigator's opinion would prevent completion of treatment and would interfere with follow- up or ability to complete questionnaires
Hip prosthesis
Inability or refusal to provide informed consent
Evidence of Previous TURP
Prior hormone therapy
Prior TURP

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian J Moran, MD	Chicago Prostate Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chicago Prostate Center	Recruiting	Westmont	Illinois	60559	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