Optimized 2D-RT for Prostate Cancer

NCT03339531 | Completed

• 1 other identifier: 2D-RT in prostate cancer
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prostate Cancer

Keywords

2D; prostate neoplasms; radiotherapy; simulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

2D radiotherapy

EXPERIMENTAL

Patients with prostate cancer were treated with 2D-radiotherapy

Radiation: 2D radiotherapy

Interventions

2D radiotherapy RADIATION

2D radiotherapy

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years
• clinical T stage: cT2b, cT2c, cT3a, cT3b
• informed consent
• MRI of the pelvis

You may not qualify if:

• \> 79 years
• prior surgery treatment for prostate cancer
• prior pelvic radiotherapy
• genetic syndromes of hyper-radio-sensitivity
• chronic infiammatory bowel disease

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Alessio G Morganti, MD

  Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 13, 2017
• Study Start: February 2, 2015
• Primary Completion: December 18, 2015
• Study Completion: December 18, 2015
• Last Updated: March 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share