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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014