Recruiting

ThinSeed™ vs. OncoSeed™

Sponsor:

Prostate Cancer Foundation of Chicago

Code:

NCT01379742

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

Interventions

RapidStrand seeds for use with 18g needle

ThinStrand

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT01379742

Start date

Apr, 2010

Status verified date

Feb, 2013

Primary completion date

Feb, 2013

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Iodine-125 standard 18 g needle

Rapidstrand

active comparator: 20 g needle

Thin Strand

Interventions

RapidStrand seeds for use with 18g needle

Rapidstrand seeds are standard size and are used with 20 g needles

ThinStrand

ThinStrand seeds are smaller in diameter and used with 20g needles

Primary outcome measure

  • Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

Chicago Prostate Center

Recruiting

Westmont, Illinois, United States, 60559

Contacts

Brian J Moran, MD

630-654-2515seeds@prostateimplant.com

Michelle H Braccioforte, MPH

630-366-7860mbraccioforte@prostateimplant.com

More Information

Sponsor

Prostate Cancer Foundation of Chicago

Last update posted

Feb 13, 2013

Last verified

Feb, 2013

Keywords

  • prostate cancer
  • prostate brachytherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Prostate Cancer Foundation of Chicago on 2013-02-13.