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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
RapidStrand seeds for use with 18g needle
ThinStrand
Sponsored by
Prostate Cancer Foundation of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, prostate brachytherapy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chicago Prostate CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Iodine-125 standard 18 g needle

20 g needle

Arm Description

Rapidstrand

Thin Strand

Outcomes

Primary Outcome Measures

Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire
Randomized

Secondary Outcome Measures

Full Information

First Posted
June 20, 2011
Last Updated
February 11, 2013
Sponsor
Prostate Cancer Foundation of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01379742
Brief Title
Comparison of Between ThinSeed™ and OncoSeed™ for Permanent Prostate Brachytherapy
Official Title
Comparison of Health Related Quality of Life and Other Clinical Parameters Between ThinSeed™ and OncoSeed™ for Permanent Low Dose Rate Implantation in Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prostate Cancer Foundation of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, prostate brachytherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iodine-125 standard 18 g needle
Arm Type
Active Comparator
Arm Description
Rapidstrand
Arm Title
20 g needle
Arm Type
Active Comparator
Arm Description
Thin Strand
Intervention Type
Device
Intervention Name(s)
RapidStrand seeds for use with 18g needle
Other Intervention Name(s)
Both Rapidstrand and Thinstrand are manufactured by Oncura
Intervention Description
Rapidstrand seeds are standard size and are used with 20 g needles
Intervention Type
Device
Intervention Name(s)
ThinStrand
Other Intervention Name(s)
Both ThinStrand and RapidStrand are manufactured by Oncura.
Intervention Description
ThinStrand seeds are smaller in diameter and used with 20g needles
Primary Outcome Measure Information:
Title
Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire
Description
Randomized
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian J Moran, MD
Organizational Affiliation
Chicago Prostate Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chicago Prostate Center
City
Westmont
State/Province
Illinois
ZIP/Postal Code
60559
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian J Moran, MD
Phone
630-654-2515
Email
seeds@prostateimplant.com
First Name & Middle Initial & Last Name & Degree
Michelle H Braccioforte, MPH
Phone
630-366-7860
Email
mbraccioforte@prostateimplant.com

12. IPD Sharing Statement

Learn more about this trial

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

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