Acute Toxicity and Quality of Life in a Post-Prostatectomy Ablative Radiation Therapy (POPART) Multicentric Trial

Curr Oncol. 2022 Nov 30;29(12):9349-9356. doi: 10.3390/curroncol29120733.

Abstract

Background: The aim of this study was to investigate the feasibility of ultrahypofractionated radiotherapy to the prostate bed in patients with biochemical and/or clinical relapse following radical prostatectomy who were enrolled in the prospective, observational, multicentric POPART trial (NCT04831970).

Methods: Patients with post-radical prostatectomy PSA levels of ≥0.1-2.0 ng/mL and/or local relapse at PSMA PET/CT or multiparametric MRI were treated with Linac-based SBRT on the prostate bed up to a total dose of 32.5 Gy in five fractions every other day (EQD21.5 = 74.2 Gy). Maximum acute toxicity was assessed using the Common Terminology Criteria for Adverse Events version 5 scale. International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) scores were assessed at baseline and during the follow-up.

Results: From April 2021 to June 2022, thirty men with a median age of 72 years (range 55-82) were enrolled in three centers. The median PSA level before RT was 0.30 ng/mL (range 0.18-1.89 ng/mL). At 3 months post-treatment, no GI or ≥2 GU side effects were reported; three patients (10%) experienced Grade 1 GU toxicity. No changes in ICIQ-SF or in the urinary domains of EPIC-CP were observed, while a transient worsening was registered in the bowel domain. At the same time point, all but two patients, who progressed distantly, were found to be biochemically controlled with a median post-treatment PSA level of 0.07 ng/mL (range 0-0.48 ng/mL).

Conclusions: Our preliminary findings show that SBRT can be safely extended to the postoperative setting, without an increase in short-term toxicity or a significant decline in QoL. Long-term results are needed to confirm this strategy.

Keywords: SBRT; postoperative setting; prostate cancer.

Publication types

  • Observational Study
  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / surgery
  • Positron Emission Tomography Computed Tomography
  • Prospective Studies
  • Prostate-Specific Antigen*
  • Prostatectomy / adverse effects
  • Prostatic Neoplasms* / radiotherapy
  • Prostatic Neoplasms* / surgery
  • Quality of Life

Substances

  • Prostate-Specific Antigen

Associated data

  • ClinicalTrials.gov/NCT04831970

Grants and funding

This research received no external funding.