NCT03339531

Optimized 2D-RT for Prostate Cancer

Completed NA Last updated 13 March 2018

What this trial tests

NA trial testing 2D radiotherapy in Prostate Cancer in 20 participants. Completed in 18 December 2015.

Timeline

2 February 2015

Primary endpoint
18 December 2015

18 December 2015

Quick facts

Lead sponsor	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	2 February 2015
Primary completion	18 December 2015
Estimated completion	18 December 2015

Drugs / interventions tested

• 2D radiotherapy

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna — full company profile →

Who can join

Adults 18 to 79, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Definition of fields margins for the optimized 2D radiotherapy of prostate carcinoma.
   Buwenge M, Perrone M, Siepe G, Capocaccia I, et al · · 2019 · PMID 31289675 · DOI 10.3892/mco.2019.1855