NCT00084526

Brief Summary

RATIONALE: New imaging procedures such as CT-on-rails™ may improve the ability to pinpoint the location of the tumor and decrease radiation therapy damage to healthy tissue. PURPOSE: This phase I/II trial is studying how well computed tomography (CT) scans using CT-on-rails™ work in pinpointing the location of the tumor in patients with prostate cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 prostate-cancer

Timeline
Completed

Started Nov 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2004

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

February 12, 2010

Status Verified

February 1, 2010

First QC Date

June 10, 2004

Last Update Submit

February 11, 2010

Conditions

Prostate Cancer

Keywords

recurrent prostate cancerstage I prostate cancerstage II prostate cancerstage III prostate cancerstage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Validity of CT-on-rails software

Secondary Outcomes (2)

  • Efficacy of fiducials

  • Treatment setup and target position uncertainties

Interventions

computed tomographyPROCEDURE
ultrasound imagingPROCEDURE

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of definitive prostate cancer * Radiotherapy planned as treatment PATIENT CHARACTERISTICS: Age * Any age Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Steven Feigenberg, MD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 10, 2004

First Posted

June 11, 2004

Study Start

November 1, 2003

Study Completion

February 1, 2007

Last Updated

February 12, 2010

Record last verified: 2010-02

Locations

US(1)