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

NCT00381966 | Completed Results

• 4 other identifiers: J05115R44CA088139-0405-03-28-03SBIR Ph1/Ph2
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Brachytherapy

Outcome Measures

Primary Outcomes (2)

• Positioning Effectiveness as Determined by Confirmatory Measurements of Robotic Movements

  Confirmatory measurements of robotic movements was assessed using infrared tracking to calculate mean error in millimeters.

  at time of intervention

• Utility of the Needle Position Device: Number of Adjustments Possible Out of Adjustments Attempted

  Utility was demonstrated in terms of fine adjustments (≤ 2 mm) and adjustments \>2mm in needle positioning, being possible when tissue deflection was encountered.

  at time of intervention

Study Arms (1)

Robotic placement device

EXPERIMENTAL

The intervention involves use of a robotic template to assist in placement of needles for prostate brachytherapy.

Device: robotic placement device

Interventions

robotic placement device 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.

Also known as: template guided robotic placement tool

Robotic placement device

Eligibility Criteria

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

You may qualify if:

• 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 (KPS) \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Daniel Song
• Organization: Johns Hopkins University

dsong2@jhmi.edu

401-502-5875

Study Officials

• Danny Song, M.D.

  The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2006
• First Posted: September 28, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 26, 2019
• Results First Posted: June 29, 2018

Record last verified: 2019-11

Locations

US (1)