- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01379742
Comparison of Between ThinSeed™ and OncoSeed™ for Permanent Prostate Brachytherapy
February 11, 2013 updated by: Prostate Cancer Foundation of Chicago
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
240
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Westmont, Illinois, United States, 60559
- Recruiting
- Chicago Prostate Center
-
Contact:
- Brian J Moran, MD
- Phone Number: 630-654-2515
- Email: seeds@prostateimplant.com
-
Contact:
- Michelle H Braccioforte, MPH
- Phone Number: 630-366-7860
- Email: mbraccioforte@prostateimplant.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Iodine-125 standard 18 g needle
Rapidstrand
|
Rapidstrand seeds are standard size and are used with 20 g needles
Other Names:
ThinStrand seeds are smaller in diameter and used with 20g needles
Other Names:
|
Active Comparator: 20 g needle
Thin Strand
|
Rapidstrand seeds are standard size and are used with 20 g needles
Other Names:
ThinStrand seeds are smaller in diameter and used with 20g needles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire
Time Frame: 1 year
|
Randomized
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Brian J Moran, MD, Chicago Prostate Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
June 20, 2011
First Submitted That Met QC Criteria
June 22, 2011
First Posted (Estimate)
June 23, 2011
Study Record Updates
Last Update Posted (Estimate)
February 13, 2013
Last Update Submitted That Met QC Criteria
February 11, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Thin-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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