Optimized 2D-RT for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Definition of Fields Margins for Optimized 2D Radiotherapy of Prostate Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03339531
• Other study ID #: 2D-RT in prostate cancer
• Status: Completed
• Phase: N/A
• First received: November 3, 2017
• Last updated: March 12, 2018
• Start date: February 2, 2015
• Est. completion date: December 18, 2015

Study information

• Verified date: March 2018
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prostate cancer (CAP) is one of the most common malignancies in men, both in Western countries and developing countries. Radiation therapy (RT) is an important therapeutic option. New technologies (3D, IMRT, IGRT, VMAT) have been introduced in the last decades, with a progressive improvement of clinical outcome. However, in many countries the only treatment option is the traditional 2D technique based on standard simulation. The indications for field definition in this treatment are still based on expert's opinions. The aim of this analysis is to propose new indications for 2D fields definition based on three-dimensional simulation in a population of patients with CAP. Twenty patients with CAP consecutively treated with RT in our center were identified. Patients underwent CT-simulation in supine position. Pelvic MRI images were fused with CT-simulation images. In this way, delineation of the prostate and seminal vesicles was performed on MRI images. Clinical Target Volume definition (CTV) was performed according to EORTC guidelines simulating 4 different categories: low-risk CAP, intermediate-risk CAP, high-risk CAP without involvement of the seminal vesicles, and high-risk CAP with involvement of seminal vesicles. The Planning Target Volume (PTV) was defined by adding a margin of 10 mm to the CTV in all directions. For each patient, 8 treatment plans were calculated. In particular, for each of the 4 categories of risk, 2 treatment plans were calculated by using a cobalt source or 10 MV photons. Treatment plans were calculated using the box technique. Progressive optimization was realized with an iterative procedure by evaluating the three-dimensional dose distribution. Once the final plan was achieved (respecting the PTV constraint: D98 > 95%), distances of the fields edges from a set of reference points were measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 18, 2015
• Est. primary completion date: December 18, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• > 18 years

• clinical T stage: cT2b, cT2c, cT3a, cT3b

• informed consent

• MRI of the pelvis

Exclusion Criteria:

• > 79 years

• prior surgery treatment for prostate cancer

• prior pelvic radiotherapy

• genetic syndromes of hyper-radio-sensitivity

• chronic infiammatory bowel disease

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• 2D radiotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	new indications for 2D fields definition	Twenty patients with prostate cancer (CAP) were identified. Pelvic MRI images were fused with CT-simulation images to delineate prostate and seminal vesicles on MRI images. Clinical Target Volume definition (CTV) was performed according to EORTC guidelines simulating 4 different categories: low-risk CAP, intermediate-risk CAP, high-risk CAP with or without involvement of the seminal vesicles. The Planning Target Volume (PTV) was defined by adding a margin of 10 mm to the CTV. For each patient, 8 treatment plans were calculated using box tecnhique: 2 treatment plans for each risk category were calculated by using a cobalt source or 10 MV photons. Progressive optimization was realized with an iterative procedure by evaluating the three-dimensional dose distribution. Once the final plan was achieved (respecting the PTV constraint: D98 > 95%), distances of the fields edges from a set of reference points were measured.	through study completion, up to 10 months