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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Prostate Cancer Foundation of Chicago.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01379742
First Posted: June 23, 2011
Last Update Posted: February 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prostate Cancer Foundation of Chicago
  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 (Participant)
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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Prostate Cancer Foundation of Chicago
ClinicalTrials.gov Identifier: NCT01379742     History of Changes
Other Study ID Numbers: Thin-1
First Submitted: June 20, 2011
First Posted: June 23, 2011
Last Update Posted: February 13, 2013
Last Verified: February 2013

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