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

NCT02672449 | Unknown DMC

• 1 other identifier: IEO 98
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of Prostate

Keywords

Prostate cancer; Carbon ions; Radiobiology; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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).

  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 Outcomes (4)

• 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

  two years

• Number of patients with biochemical progression free survival measuring the PSA level

  two years

• Number of patients who experienced local or distance recurrence of disease assessed through radiological controls (Choline PET Scan, MRI)

  two years

• Overall survival assessed by number of patients alive (with or without relapse) after the treatment

  Two years

Study Arms (1)

External beam radiotherapy

EXPERIMENTAL

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

Interventions

Carbon Ions Boost Followed by Pelvic Photon Radiotherapy RADIATION

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).

External beam radiotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead
• Associazione Italiana per la Ricerca sul Cancro: collaborator

Study Sites (1)

European Institute of oncology

Milan, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 28190704 DERIVED

• 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.

  PMID: 28185875 DERIVED

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

• Roberto Orecchia, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Orecchia, MD

CONTACT

roberto.orecchia@ieo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: February 3, 2016
• Study Start: May 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)