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

This study is currently recruiting participants.
Verified February 2013 by Prostate Cancer Foundation of Chicago
Sponsor:
Information provided by (Responsible Party):
Prostate Cancer Foundation of Chicago
ClinicalTrials.gov Identifier:
NCT01379742
First received: June 20, 2011
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Device: RapidStrand seeds for use with 18g needle
Device: ThinStrand
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Prostate Cancer Foundation of Chicago:

Primary Outcome Measures:
  • Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Randomized


Estimated Enrollment: 240
Study Start Date: April 2010
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Iodine-125 standard 18 g needle
Rapidstrand
Device: RapidStrand seeds for use with 18g needle
Rapidstrand seeds are standard size and are used with 20 g needles
Other Name: Both Rapidstrand and Thinstrand are manufactured by Oncura
Device: ThinStrand
ThinStrand seeds are smaller in diameter and used with 20g needles
Other Name: Both ThinStrand and RapidStrand are manufactured by Oncura.
Active Comparator: 20 g needle
Thin Strand
Device: RapidStrand seeds for use with 18g needle
Rapidstrand seeds are standard size and are used with 20 g needles
Other Name: Both Rapidstrand and Thinstrand are manufactured by Oncura
Device: ThinStrand
ThinStrand seeds are smaller in diameter and used with 20g needles
Other Name: Both ThinStrand and RapidStrand are manufactured by Oncura.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01379742

Locations
United States, Illinois
Chicago Prostate Center Recruiting
Westmont, Illinois, United States, 60559
Contact: Brian J Moran, MD    630-654-2515    seeds@prostateimplant.com   
Contact: Michelle H Braccioforte, MPH    630-366-7860    mbraccioforte@prostateimplant.com   
Sponsors and Collaborators
Prostate Cancer Foundation of Chicago
Investigators
Principal Investigator: Brian J Moran, MD Chicago Prostate Center
  More Information

No publications provided

Responsible Party: Prostate Cancer Foundation of Chicago
ClinicalTrials.gov Identifier: NCT01379742     History of Changes
Other Study ID Numbers: Thin-1
Study First Received: June 20, 2011
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Prostate Cancer Foundation of Chicago:
prostate cancer
prostate brachytherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014