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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Intraprostatic Fiducial Markers For External Beam Radiation Therapy

NCT00499421

Prostate Cancer

COMPLETED

Evaluation of Radiation Therapy Positioning System (RTPS) in Patients With Localized Prostate Cancer

NCT00921193

Prostate Cancer

COMPLETED NA

Prostate Cancer Stereotactic Radiotherapy

NCT02319239

Prostate Neoplasms Toxicity Due to Radiotherapy

COMPLETED NA

Role of Magnetic Resonance Imaging (MRI) Perfusion to Detect Disease in Prostate Carcinoma

NCT00230386

Prostatic Neoplasms

COMPLETED PHASE1/PHASE2

Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment

NCT00061347

Prostate Cancer Cancer

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostatic Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stent

Group Type EXPERIMENTAL

Radiotherapy stent

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiotherapy stent

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 -