Carbon Ions Boost Followed by Pelvic Photon Radiotherapy for High Risk Prostate Cancer

June 27, 2023 updated by: European Institute of Oncology
The aim of this research project is to test the feasibility and safety of a new treatment schedule for high risk prostate cancer that allows the administration of high doses to the prostate tumor with a mixed beam approach of carbon ions boost followed by pelvic IMRT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The present research project aims to improve the current treatment for high risk prostate cancer, evaluating the safety and feasibility of a new RT scheme of a carbon ions boost followed by pelvic photon RT.

A total of 65 consecutive patients will be enrolled in a prospective phase II trial. The patients will be enrolled either at Centro Nazionale di Adroterapia Oncologica (CNAO), Pavia, Italy, at the Division of Radiation Oncology of the European Institute of Oncology (IEO), Milan, Italy, or at the Fondazione IRCCS Istituto Nazionale Tumori (INT), Milan, Italy.

The treatment will include a boost phase on the whole prostate with carbon ions performed at CNAO followed by a pelvic photon IMRT performed with conventional fractionation of 1.8 Gy per fraction up to 45 Gy to the pelvic lymph nodes, prostate and seminal vesicles. All the patient data will be collected in a common database accessible from the 3 Institutions.

At CNAO, carbon ions beam is available for patient treatment since 2011. In comparison to the Japanese Center NIRS, the facility relies on active beam delivery using the rasterscan technique, which offers not only physical advantages with better sparing of normal tissues in the entrance channel, but also enables biologic plan optimization. The facility has the same equipment as the Carbon Ion Treatment Center in Heidelberg, Germany. At CNAO, 3D - 4D patient target localization is verified at each fraction by integrating orthogonal X-ray images and 3D real time optical tracking system.

At IEO and INT, the IMRT phase will be performed with the same treatment modality: volumetric-IMRT RapidArc by Varian Trilogy (IEO) and Varian DHX (INT) linacs, Varian Medical Systems, Palo Alto, CA, USA, with treatment based on the isocentric beam delivery, and pre-treatment image guidance for patient alignment via cone beam CT or portal imaging.

In phantom, quality assurance (QA) of each treatment will be performed before patient RT, in order to verify the consistency between calculated and delivered dose.

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy
        • Recruiting
        • European Institute of Oncology
        • Principal Investigator:
          • Roberto Orecchia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate, high-risk category according to NCCN version 2013 (T3a and/or PSA > 20 ng/ml and/or Gleason score of 8-10)
  • cN0 and cM0
  • Good performance status (ECOG<2)
  • No previous pelvic RT
  • No previous prostatectomy
  • No concomitant bowel inflammatory disease or other serious comorbidities
  • Good urinary flow (peak flow > 10 ml/s)
  • No previous invasive cancer (within 5 years before the PCa diagnosis) apart from non-melanoma skin malignancies.

Exclusion criteria

  • Pelvic lymph node metastasis (N1)
  • Distant metastasis (M1)
  • Urinary obstructive symptoms (IPSS > 20)
  • Previous pelvic radiotherapy
  • Severe systemic disorders
  • Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin)
  • Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like in situ cervix cancer or non muscle invasive bladder cancer
  • Non conformity of the radiotherapy dose distribution when compared to the dose constraints
  • Psychiatric disorders or any other condition that can can make unreliable the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: External beam radiotherapy
A total of 65 consecutive newly diagnosed prostate cancer patients with 2013 NCCN high risk category will be consecutively enrolled in a prospective phase II trial on Carbon Ions Boost Followed by Pelvic Photon Radiotherapy .
Radiation: Carbon Ions Boost Followed by Pelvic Photon Radiotherapy
The patients will be enrolled either at the Centro Nazionale di Adroterapia Oncologica (CNAO), Pavia, Italy, at the Division of Radiation Oncology of the European Institute of Oncology (IEO), Milan, Italy, or at the Fondazione IRCCS Istituto Nazionale Tumori (INT), Milan, Italy. The treatment will include a boost phase on the whole prostate with carbon ions performed at CNAO followed by a pelvic photon RT, with IMRT performed with conventional fractionation of 1.8 Gy per fraction up to 45 Gy to the pelvic lymph nodes, prostate and seminal vesicles. The total dose prescribed to the prostate boost with carbon ions will be of 16.6 GyE in 4 fractions (4.15 GyE/fraction).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with Grade 3 or Grade 4 adverse events that are related to radiotherapy treatment according to the validated scale Radiotherapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG / EORTC).
Time Frame: one month after radiotherapy
Toxicity and quality of life data will be prospectively assessed and analysed descriptively. Toxicities will be graded according to the Common Toxicity Criteria for adverse events (CTCAE) toxicity criteria v4.0 and Radiotherapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) criteria. Inacceptable toxicity will be > 3 patients with acute side effects grade 4, or > 3 patients with late RTOG/EORTC, CTCAE side effects grade 4, or > 3 patients with late RTOG/EORTC, CTCAE side effects grade 3, or any grade 5 toxicity.
one month after radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who experienced late toxicity with Grade 3 or Grade 4 adverse events according to Scala CTCAE v4.0 toxicity criteria and scale RTOG / EORTC
Time Frame: two years
two years
Number of patients with biochemical progression free survival measuring the PSA level
Time Frame: two years
Biochemical progression free survival will be measured from the beginning date of RT to the date of PSA elevation. PSA relapse is defined according to the Consensus Statement of the American Society of Radiation Oncology (ASTRO) as elevation of PSA levels nadir + 2 ng/ml and confirmed by one measurement
two years
Number of patients who experienced local or distance recurrence of disease assessed through radiological controls (Choline PET Scan, MRI)
Time Frame: two years
It will be considered pattern of failure relapse in the same prostate lobe, in other lobes, in lymph nodes, in other distant sites.
two years
Overall survival assessed by number of patients alive (with or without relapse) after the treatment
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Collaborators

Associazione Italiana per la Ricerca sul Cancro

Investigators

  • Principal Investigator: Roberto Orecchia, MD, European Institute of Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

February 1, 2016

First Posted (Estimated)

February 3, 2016

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEO 98

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adenocarcinoma of Prostate

Clinical Trials on Carbon Ions Boost Followed by Pelvic Photon Radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe