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

February 11, 2013 updated by: Prostate Cancer Foundation of Chicago

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Both Rapidstrand and Thinstrand are manufactured by Oncura
Device: ThinStrand
ThinStrand seeds are smaller in diameter and used with 20g needles
Other Names:
  • 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 Names:
  • Both Rapidstrand and Thinstrand are manufactured by Oncura
Device: ThinStrand
ThinStrand seeds are smaller in diameter and used with 20g needles
Other Names:
  • Both ThinStrand and RapidStrand are manufactured by Oncura.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire
Time Frame: 1 year
Randomized
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prostate Cancer Foundation of Chicago

Investigators

  • Principal Investigator: Brian J Moran, MD, Chicago Prostate Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

June 20, 2011

First Submitted That Met QC Criteria

June 22, 2011

First Posted (Estimate)

June 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 13, 2013

Last Update Submitted That Met QC Criteria

February 11, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Thin-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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