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
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, prostate brachytherapy
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
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
NCT ID
NCT01379742
First Posted
June 20, 2011
Last Updated
February 11, 2013
Sponsor
Prostate Cancer Foundation of Chicago
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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