Acute toxicity and quality of life in patients with prostate cancer treated with protons or carbon ions in a prospective randomized phase II study – the IPI trial

Publication date: Available online 12 February 2016
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Gregor Habl, Matthias Uhl, Sonja Katayama, Kerstin A. Kessel, Gencay Hatiboglu, Boris Hadaschik, L. Edler, Diana Tichy, Malte Ellerbrock, Thomas Haberer, Maja B. Wolf, Heinz-Peter Schlemmer, Jürgen Debus, Klaus Herfarth
BackgroundTo evaluate safety and feasibility of primary hypofractionated raster-scanned irradiation of the prostate with protons and carbon ions in a prospective randomized phase II trial.Methods and MaterialsIn this trial, 92 patients with localized prostate cancer were enrolled. Patients were randomized either to protons (arm A) or carbon ions (arm B) and treated with a total dose of 66 Gy(RBE) administered in 20 fractions (single dose of 3.3 Gy(RBE). Patients were stratified by the use of antihormonal therapy. Primary endpoint was the combined assessment of safety and feasibility. Secondary endpoints were specific toxicities, PSA-progression free survival (PSA-PFS), overall survival (OS) and quality-of-life (QoL).Results91 patients completed therapy with a median follow-up of 22.3 months. Among acute genitourinary toxicities, cystitis rates were 34.1% (A: 39.1%, B: 28.9%) grade 1 and 17.6% (A: 21.7%, B: 13.3%) grade 2. Seven patients (8%) required urinary catheterization during treatment due to urinary retention, of whom five were in arm A. Regarding acute gastrointestinal toxicities, two patients treated with protons developed a rectum fistula of grade 3. Radiation proctitis occurred in 12.1% (A: 13.0%, B: 11.1%) as grade 1 and in 5.5% (A: 8.7%, B: 2.2%) as grade 2. No statistically significant differences in the toxicity profiles regarding both arms were found. QoL was mainly reduced regarding fatigue, pain and urinary symptoms during therapy and six weeks thereafter. All EORTC QLQ-C30 and -PR25 scores improved during follow-up.ConclusionHypofractionated irradiation using either carbon ions or protons results in comparable acute toxicities and QoL parameters. We found that hypofractionated particle irradiation is feasible and might be safe. Due to the occurrence of gel in the rectum wall and the consecutive occurrence of two rectal fistulas, we stopped using the insertion of spacer gel. Longer follow-up is necessary for evaluation of PFS and OS.

Teaser

To gain data for hypofractionated irradiation of the prostate with protons and carbon ions in an active raster scan technique the IPI trial (n = 92) was initiated. Primary endpoint was the assessment of safety and feasibility. Secondary endpoints were PSA-progression free survival (PSA-PFS), overall survival (OS) and quality-of-life (QoL). We could show that treatment with protons and carbon ions was safe and feasible with comparable acute toxicities and QoL parameters


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