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

NCT01379742 | Unknown Phase 4 DMC

• 1 other identifier: Thin-1
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Keywords

prostate cancer; prostate brachytherapy

Outcome Measures

Primary Outcomes (1)

• Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire

  Randomized

  1 year

Study Arms (2)

Iodine-125 standard 18 g needle

ACTIVE COMPARATOR

Rapidstrand

Device: RapidStrand seeds for use with 18g needle; Device: ThinStrand

20 g needle

ACTIVE COMPARATOR

Thin Strand

Device: RapidStrand seeds for use with 18g needle; Device: ThinStrand

Interventions

RapidStrand seeds for use with 18g needle DEVICE

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

Also known as: Both Rapidstrand and Thinstrand are manufactured by Oncura

20 g needle; Iodine-125 standard 18 g needle

ThinStrand DEVICE

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

Also known as: Both ThinStrand and RapidStrand are manufactured by Oncura.

20 g needle; Iodine-125 standard 18 g needle

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prostate Cancer Foundation of Chicago: lead

Study Sites (1)

Chicago Prostate Center

Westmont, Illinois, 60559, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Needles

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Brian J Moran, MD

  Chicago Prostate Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 23, 2011
• Study Start: April 1, 2010
• Primary Completion: February 1, 2013
• Last Updated: February 13, 2013

Record last verified: 2013-02

Locations

US (1)