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. 2022 Nov 2:12:951220.
doi: 10.3389/fonc.2022.951220. eCollection 2022.

Early results of PRO-EPI: PROspective multicenter observational study on elective pelvic nodes irradiation in patients with intermediate/high/very high-risk non-metastatic prostate cancer submitted to radical, adjuvant, or salvage radiotherapy with or without concomitant androgen deprivation therapy

Andrea Emanuele Guerini  1 , Marianna Noale  2 , Gianluca Mortellaro  3 , Roberto Lisi  4 , Alessio Bruni  5 , Roberto Santini  6 , Paolo Muto  7 , Giuseppe Ferrera  3 , Gianluca Cossali  1 , Vittorio Morelli  1 ; PRO-EPI study group; Stefano Maria Magrini  1 , Luigi Spiazzi  8 , Michela Buglione  1
Affiliations

Early results of PRO-EPI: PROspective multicenter observational study on elective pelvic nodes irradiation in patients with intermediate/high/very high-risk non-metastatic prostate cancer submitted to radical, adjuvant, or salvage radiotherapy with or without concomitant androgen deprivation therapy

Andrea Emanuele Guerini et al. Front Oncol. .

Abstract

Simple Summary: Although radiotherapy plays a fundamental role in the management of intermediate/high/very high-risk non-metastatic prostatic cancer (IHR-nmPca), there is still no consensus on the optimal treatment strategy in this setting. Remarkably, the role of elective nodal irradiation (ENI) is still highly controversial. The PROspective multicenter observational study on Elective Pelvic nodes Irradiation (PRO-EPI) was designed to provide "real life" data regarding the patterns of care for IHR-nmPca. Forty-three Italian Radiation Oncology centers participated in the PROspective multicenter observational study on Elective Pelvic nodes Irradiation (PRO-EPI) project, with 1029 patients enrolled. In this preliminary analysis, we longitudinally evaluated the impact of Elective Nodal Irradiation (ENI) and radiotherapy features on toxicity and quality of life (QoL). Six months follow-up data were available for 913 patients and 12 months data for 762 patients. Elective Nodal Irradiation was given to 506 patients (48.9%). Volumetric Intensity-Modulated Radiation Therapy (IMRT) was adopted in more than 77% of patients and Image-Guided Radiation Therapy (IGRT) in 84.4%. Androgen deprivation therapy (ADT) was administered to the majority of patients (68.3%), and it was associated to ENI in 408 cases (81.1%). Toxicity was mostly mild and reversible and IGRT resulted in a significant reduction of rectal toxicity, although a non-significant trend toward increased urinary toxicity was observed. No statistically significant differences in QoL and toxicity were seen in patients treated with or without ENI. The adoption of IGRT is widespread and increasing and could reduce treatment toxicity. ENI is not yet the standard treatment, but it is performed in a growing fraction of cases and not resulting into an increase in toxicity or in a deterioration of QoL. Further analyses are needed to clarify the long-term toxicity profile and the impact of ENI on survival.

Keywords: ADT; IGRT (Image Guided Radiation Therapy); IMRT (intensity modulated radiation therapy); VMAT (volumetric modulated arc therapy); pelvic nodal irradiation; prostate cancer; radiotherapy.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Flowchart of the PRO-EPI study. *Risk according to NCCN: intermediate (T2b, T2c, or Gleason score = 7 or 10 < PSA ≤ 20 ng/ml); high (T3a or Gleason score 8, 9, 10, or PSA > 20 ng/ml); very high (T3b, T4, or multiple risk factors for high risk).
Figure 2
Figure 2
Treatment flow diagram according to nodal status.
Figure 3
Figure 3
Rectal and urinary and bowel toxicity in the overall population, by time. Rectal toxicities: data available at 1 month for 990 patients, at 3 months for 965, at 6 months for 925, at 12 months for 762 patients. Urinary toxicities: data available at 1 month for 990 patients, at 3 months for 965, at 6 months for 926, and at 12 months for 762 patients.
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