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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01379742
• Other study ID #: Thin-1
• Status: Recruiting
• Phase: Phase 4
• First received: June 20, 2011
• Last updated: February 11, 2013
• Start date: April 2010

Study information

• Verified date: February 2013
• Source: Prostate Cancer Foundation of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Chicago Prostate Center	Westmont	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Prostate Cancer Foundation of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire	Randomized	1 year	No