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Study of Robotic Template Guidance for Needle Placement in Transperineal Prostate Brachytherapy (J0511)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00381966
First received: September 27, 2006
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  Purpose

This is a study that will try see if a device can help to better guide the needle that places prostate cancer treatment.


Condition Intervention
Prostate Cancer
 Device: robotic placement device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Pilot Study of Robotic Template Guidance for Needle Placement in Transperineal Prostate Brachytherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • This will be a feasibility trial of a therapeutic device the needle positioner device using the system in an actual operating room environment and determining acceptable positioning effectiveness. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: June 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: robotic placement device
    this device is a robotic arm that utilizes a template as a guidance system to precisely inplant radioactive brachytherapy seeds directly to the prostate.
    Other Name: template guided robotic placement tool
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria are unchanged from our standard criteria for brachytherapy eligibility:

  • Histologically confirmed, locally confined adenocarcinoma of the prostate
  • Clinical stages T1b - T2b
  • PSA of less than 20 ng/mL
  • Combined Gleason score 7 or less, with no individual Gleason score of 5
  • The patient has decided to undergo brachytherapy at the Johns Hopkins Hospital as treatment choice for his prostate cancer.
  • Karnofsky Performance Status > 70
  • Prostate volume by TRUS < 50 cc
  • International Prostate symptom score (IPSS) must be 18 or less
  • Signed study-specific consent form prior to registration

Exclusion Criteria:

  • Stage T1a, or T3 or greater disease.
  • Clinical or Pathological Lymph node involvement (N1).
  • Evidence of distant metastases (M1).
  • Radical surgery for carcinoma of the prostate.
  • Previous Chemotherapy or pelvic radiation therapy
  • Previous transurethral resection of the prostate (TURP)
  • Significant obstructive symptoms (IPSS greater than 18)
  • Hip prosthesis.
  • Anatomic or medical condition (such as prior abdominal-perineal resection or anal stricture) which would preclude the use of TRUS
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381966

Locations
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Danny Song, M.D. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00381966     History of Changes
Other Study ID Numbers: J0511, 5R44CA088139-04, (SBIR Ph1/Ph2)
Study First Received: September 27, 2006
Last Updated: November 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Prostate Cancer
Brachytherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013