Abstract
PurposeThis study represents a descriptive analysis of preliminary results of a Phase II trial on a novel mixed beam radiotherapy (RT) approach, consisting of carbon ions RT (CIRT) followed by intensity-modulated photon RT, in combination with hormonal therapy, for high-risk prostate cancer (HR PCa) with a special focus on acute toxicity.MethodsPrimary endpoint was the evaluation of safety in terms of acute toxicity. Secondary endpoints were early and long-term tolerability of treatment, quality of life (QoL), and efficacy. Data on acute and late toxicities were collected according to RTOG/EORTC. QoL of enrolled patients was assessed by IPSS, EORTC QLQ-C30, EORTC QLQ-PR25, and sexual activity by IIEF-5.ResultsTwenty-six patients were enrolled in the study, but only 15 completed so far the RT course and were included. Immediately after CIRT, no patients experienced GI/GU toxicity. At 1 and 3 months from the whole course RT completion, no GI/GU toxicities greater than grade 2 were observed. QoL scores were overall satisfactory.ConclusionsThe feasibility of the proposed mixed treatment schedule was assessed, and an excellent acute toxicity profile was recorded. Such findings instil confidence in the continuation of this mixed approach, with evaluation of long-term tolerability and efficacy.
Highlights
Prostate cancer (PCa) is the most common solid organ malignancy in men, and radiotherapy (RT) plays a significant role in the treatment of organ-confined or locally advanced disease [1]
In the light of improving outcomes in HR PCa patients without compromising treatment safety, we explored the use of carbon ions to escalate the dose to the prostate and the addition of a standard photon treatment to the pelvic lymph nodes
Sixteen patients have completed the prescribed treatment according to protocol guidelines so far, and one patient dropped out the protocol due to non-PCa-related clinical motivations, so 15 patients were included in the analysis
Summary
Prostate cancer (PCa) is the most common solid organ malignancy in men, and radiotherapy (RT) plays a significant role in the treatment of organ-confined or locally advanced disease [1]. From a RT perspective, the most peculiar biological feature of PCa is its low a/b ratio, corresponding to a relative radio-resistance, which has fostered the development through the years of different schedules with varying degrees of hypofractionation. Many of these studies [4, 5] have demonstrated to be if not more effective in terms of local control and less likely to cause side effects. The role of hypofractionation with stereotactic body RT (SBRT) in HR PCa patients remains controversial, especially when it becomes necessary to perform elective pelvic nodal irradiation [6]
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