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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02672449
First Posted: February 3, 2016
Last Update Posted: February 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Associazione Italiana per la Ricerca sul Cancro
Information provided by (Responsible Party):
European Institute of Oncology
  Purpose
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.

Condition Intervention
Adenocarcinoma of Prostate Radiation: Carbon Ions Boost Followed by Pelvic Photon Radiotherapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Carbon Ions Boost Followed by Pelvic Photon Radiotherapy for High Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by European Institute of Oncology:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]
  • 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

  • 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.

  • Overall survival assessed by number of patients alive (with or without relapse) after the treatment [ Time Frame: Two years ]

Estimated Enrollment: 65
Study Start Date: May 2015
Estimated Study Completion Date: January 2020
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672449


Locations
Italy
European Institute of oncology
Milan, Italy
Sponsors and Collaborators
European Institute of Oncology
Associazione Italiana per la Ricerca sul Cancro
Investigators
Principal Investigator: Roberto Orecchia, MD European Institute of Oncology
  More Information

Responsible Party: European Institute of Oncology
ClinicalTrials.gov Identifier: NCT02672449     History of Changes
Other Study ID Numbers: IEO 98
First Submitted: January 12, 2016
First Posted: February 3, 2016
Last Update Posted: February 3, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by European Institute of Oncology:
Prostate cancer
Carbon ions
Radiobiology
Radiotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type