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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250224
• Other study ID #: stent02
• Status: Completed
• Phase: Phase 1
• First received: November 7, 2005
• Last updated: June 25, 2015
• Start date: January 2006
• Est. completion date: May 2014

Study information

• Verified date: September 2005
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2014
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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 -

Exclusion Criteria:

dislocation or removal of stent

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Device:
• Radiotherapy stent

Locations

Country	Name	City	State
Denmark	Dept of oncology	Aalborg	Nordjylland

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stent in situ during radiotherapy		8 weeks	No