NCT00250224

Brief Summary

A new method for localization of the prostate during external beam radiotherapy. The method is based on insertion of a new thermo-expandable Ni-Ti stent. The radiological properties of the stent are used for precise prostate localization during treatment using electronic portal images

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_1

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

First Submitted

Initial submission to the registry

November 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 26, 2015

Status Verified

September 1, 2005

Enrollment Period

3.3 years

First QC Date

November 7, 2005

Last Update Submit

June 25, 2015

Conditions

Prostatic Neoplasms

Keywords

Radiotherapyimage guidedmarker

Outcome Measures

Primary Outcomes (1)

  • stent in situ during radiotherapy

    8 weeks

Study Arms (1)

Stent

EXPERIMENTAL
Device: Radiotherapy stent

Interventions

Radiotherapy stentDEVICE
Stent

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients should present with histological verified local or locally advanced PC (stage T2b to T3b, N0, M0; UICC 1992 classification was used).
  • Patients should consequently be candidates for intended curative radiotherapy -

You may not qualify if:

  • dislocation or removal of stent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of oncology

Aalborg, North Denmark, 9000, Denmark

Location

Related Publications (3)

  • Carl J, Sander L. Five-year follow-up using a prostate stent as fiducial in image-guided radiotherapy of prostate cancer. Acta Oncol. 2015 Jun;54(6):862-7. doi: 10.3109/0284186X.2014.987355. Epub 2014 Dec 24.

    PMID: 25539443BACKGROUND

  • Sander L, Langkilde NC, Holmberg M, Carl J. MRI target delineation may reduce long-term toxicity after prostate radiotherapy. Acta Oncol. 2014 Jun;53(6):809-14. doi: 10.3109/0284186X.2013.865077. Epub 2013 Dec 20.

    PMID: 24358954BACKGROUND

  • Carl J, Nielsen J, Holmberg M, Larsen EH, Fabrin K, Fisker RV. Clinical results from first use of prostate stent as fiducial for radiotherapy of prostate cancer. Acta Oncol. 2011 May;50(4):547-54. doi: 10.3109/0284186X.2010.541935. Epub 2010 Dec 21.

    PMID: 21174520BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jesper Carl, PhD

    Dept medical Physics, Oncology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2005

First Posted

November 8, 2005

Study Start

January 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2014

Last Updated

June 26, 2015

Record last verified: 2005-09

Locations

DK(1)