Positioning and Tracking the Prostate During External Beam Radiation

NCT00123838 | Completed

• 1 other identifier: Prostate Stage 3
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to evaluate a non-ionizing electromagnetic method to align the prostate treatment site for radiation therapy and to monitor its position throughout radiation therapy delivery. The clinical study involves using an investigational device, the Calypso® 4D Localization System, and requires permanent implantation of three small sensors called Beacon® transponders in the prostate.

Conditions

Prostate Cancer

Keywords

Prostate; Cancer; Radiotherapy; Neoplasm; Localization; Tracking; Cancer of Prostate; Neoplasms, Prostate

Outcome Measures

Primary Outcomes (1)

• Radiographic verification of at least five of approximately 40 radiation treatment days

  8 weeks

Secondary Outcomes (1)

• Patient Preference Questionnaire and SF 36 Health Survey at five radiation treatment days

  8 week

Study Arms (1)

Single Group Assignment

EXPERIMENTAL

Calypso® 4D Localization System

Device: Calypso® 4D Localization System

Interventions

Calypso® 4D Localization System DEVICE

Localization of prostate irradiation.

Single Group Assignment

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Histologically confirmed diagnosis of prostate cancer
• Intact prostate (minor transurethral resection of the prostate \[TURP\] defects are allowed at the discretion of the investigator)
• Ability to comply with study visit schedule

You may not qualify if:

• Prior treatment for prostate cancer.
• Prostate cancer stage IV (metastatic disease).
• Patients who are not eligible for prostate biopsy.
• Past history of abdominoperineal (A-P) resection.
• Planned course of treatment using brachytherapy (permanent brachytherapy seeds or high dose rate \[HDR\] brachytherapy).
• Allergy to local anesthetics.
• Patients with any permanently implanted medical devices that have an energy source, such as pacemakers, defibrillators, neurostimulators, and drug infusion pumps; this also includes prosthetic implants in the abdomen or pelvis, such as an artificial hip; or vascular implants such as arterial stents or stent-grafts for aortic aneurysms. This does not include surgical clips, staples or coronary stents.
• History of chronic prostatitis.
• Patients with a history of recent acute and/or chronic bleeding disorders.
• Patients on therapeutic anti-coagulants or anti-platelet therapy, not including aspirin.
• Patients for which the maximum anterior-posterior separation through the torso minus the height of the center of the prostate is greater than 23 cm. (Measurements will be made visually with a ruler.)
• Baseline evaluation shows an INR or PTT outside of the normal range for the institution; platelet count \< 75,000 mm3; or creatinine \> 2.0 mg/dl.
• Any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in a clinical trial

Sponsors & Collaborators

• Varian, a Siemens Healthineers Company: lead

Study Sites (5)

Scottsdale Healthcare - Osborn

Scottsdale, Arizona, 85260, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

M.D. Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

The Nebraska Medical Center

Omaha, Nebraska, 68105, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44192, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Lisa Levine, Ph.D.

  Varian, a Siemens Healthineers Company

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 22, 2005
• First Posted: July 26, 2005
• Study Start: July 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: April 28, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)