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Prostate Localization During Radiotherapy Using a Ni-Ti Stent and Electronic Portal Imaging - Protocol II

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Radiotherapy stent
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Radiotherapy, image guided, marker

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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 - Exclusion Criteria: dislocation or removal of stent

Sites / Locations

  • Dept of oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stent

Arm Description

Outcomes

Primary Outcome Measures

stent in situ during radiotherapy

Secondary Outcome Measures

Full Information

First Posted
November 7, 2005
Last Updated
June 25, 2015
Sponsor
Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00250224
Brief Title
Prostate Localization During Radiotherapy Using a Ni-Ti Stent and Electronic Portal Imaging - Protocol II
Official Title
Prostate Localization During Radiotherapy Using a Ni-Ti Stent and Electronic Portal Imaging - Protocol II
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aalborg University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Inclusion criteria's in the study were 1) Patients should present with histological verified local or locally advanced PC (stage T2b to T3b, N0, M0; UICC 1992 classification was used). 2) Patients should consequently be candidates for intended curative radiotherapy. Prostatic work up is done before inclusion in the study. A new prostatic Nickel - Titanium stent is placed in the prostatic urethra one week prior to the radiotherapy planning CT using a flexible cystoscope to insert the stent under urethral anaesthesia. The stent is then flushed with hot water (60 degrees Celsius). The hot water expands the stent collar, thereby locking the stent in place. Correct positioning of the stent is secured visually on retraction of the scope. Radiotherapy of prostate is given to a mean dose of 70 (department standard regime). Treatment are given with daily fractions of 2 Gy using a combination of 6 MV and 18 MV X-ray fields using isocentric 3D conformal treatment plan, consisting of three MLC conformal radiation fields (One anterior and two lateral wedged fields). This was assumed to be the optimal treatment plan. A pair of orthogonal 15 cm x 15 cm isocenter setup fields was added to the plan. The orthogonal fields are used to obtain pairs of electronic portal images. Electronic portal images are recorded using a Varian As500 electronic portal imaging device (EPID). The images are used to determine the 3D reference position of the stent. The image pairs of the stent were taken at eight treatment sessions in each patient (Session number 1,2,3,6,11,21,22 and 23). From each orthogonal set of images the 3D position of both the stent and the symphysis (pubic bone) are determined. Positions are calculated using orthogonal reconstruction. A control CT scan is made before treatment session number 21 to verify the intra prostatic position of the stent. The intra prostatic position of the stent is also verified during removal of the stent three months after radiation therapy. Before removal the stent was flushed with water at 10 degrees Celsius. When cooled with 10°C cold water, the stent became super soft, and can easily be removed as a twisted wire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Radiotherapy, image guided, marker

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stent
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Radiotherapy stent
Primary Outcome Measure Information:
Title
stent in situ during radiotherapy
Time Frame
8 weeks

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 - Exclusion Criteria: dislocation or removal of stent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper Carl, PhD
Organizational Affiliation
Dept medical Physics, Oncology
Official's Role
Study Chair
Facility Information:
Facility Name
Dept of oncology
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25539443
Citation
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.
Results Reference
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PubMed Identifier
24358954
Citation
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.
Results Reference
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PubMed Identifier
21174520
Citation
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.
Results Reference
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Prostate Localization During Radiotherapy Using a Ni-Ti Stent and Electronic Portal Imaging - Protocol II

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