Clinical trial NCT02672449: Carbon Ions Boost Followed by Pelvic Photon Radiotherapy for High Risk Prostate Cancer
Official title: Carbon Ions Boost Followed by Pelvic Photon Radiotherapy for High Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adenocarcinoma of Prostate
Keywords: Prostate cancer
Carbon ions
Radiobiology
Radiotherapy
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Associazione Italiana per la Ricerca sul Cancro
First posted: 2016-02-03
Enrollment: 65
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: 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).
timeFrame: one month after radiotherapy
Secondary outcomes:
measure: 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
timeFrame: two years
measure: Number of patients with biochemical progression free survival measuring the PSA level
timeFrame: two years
measure: Number of patients who experienced local or distance recurrence of disease assessed through radiological controls (Choline PET Scan, MRI)
timeFrame: two years
measure: Overall survival assessed by number of patients alive (with or without relapse) after the treatment
timeFrame: Two years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of oncology
Study officials:
affiliation: European Institute of Oncology
name: Roberto Orecchia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marvaso G, Jereczek-Fossa BA, Riva G, Bassi C, Fodor C, Ciardo D, Cambria R, Pansini F, Zerini D, De Marco P, Cattani F, De Cobelli O, Orecchia R. High-Risk Prostate Cancer and Radiotherapy: The Past and the Future. A Benchmark for a New Mixed Beam Radiotherapy Approach. Clin Genitourin Cancer. 2017 Jun;15(3):376-383. doi: 10.1016/j.clgc.2017.01.007. Epub 2017 Jan 18.
citation: Jereczek-Fossa BA, Fanetti G, Fodor C, Ciardo D, Santoro L, Francia CM, Muto M, Surgo A, Zerini D, Marvaso G, Timon G, Romanelli P, Rondi E, Comi S, Cattani F, Golino F, Mazza S, Matei DV, Ferro M, Musi G, Nole F, de Cobelli O, Ost P, Orecchia R. Salvage Stereotactic Body Radiotherapy for Isolated Lymph Node Recurrent Prostate Cancer: Single Institution Series of 94 Consecutive Patients and 124 Lymph Nodes. Clin Genitourin Cancer. 2017 Aug;15(4):e623-e632. doi: 10.1016/j.clgc.2017.01.004. Epub 2017 Jan 11.