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

Phase 4

• Conditions: Prostate Cancer
• Interventions: Device: RapidStrand seeds for use with 18g needle; Device: ThinStrand

• Registration Number: NCT01379742
• Lead Sponsor: Prostate Cancer Foundation of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-06-20
• Study First Submitted QC: 2011-06-22
• Study First Posted: 2011-06-23
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Last Update Submitted: 2013-02-11
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 240

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iodine-125 standard 18 g needle	ThinStrand	Rapidstrand
20 g needle	RapidStrand seeds for use with 18g needle	Thin Strand
Iodine-125 standard 18 g needle	RapidStrand seeds for use with 18g needle	Rapidstrand
20 g needle	ThinStrand	Thin Strand

Primary Outcome Measures

Name	Time	Method
Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire	1 year	Randomized

Trial Locations

Locations (1)

Chicago Prostate Center; 🇺🇸 Westmont, Illinois, United States