PERSIAN trial (NCT05717660): an ongoing randomized trial testing androgen deprivation therapy, apalutamide and stereotactic body radiotherapy. An alternative "triplet" for oligometastatic hormone sensitive prostate cancer patients

Med Oncol. 2023 Dec 29;41(1):39. doi: 10.1007/s12032-023-02268-3.

Abstract

Earlier treatment intensification with systemic potent androgen receptor inhibition has been shown to improve clinical outcomes in metastatic hormone sensitive prostate cancer. Nonetheless, oligometastatic patients may benefit from local treatment approaches such as stereotactic body radiotherapy (SBRT). Aiming to explore the benefit of SBRT in this scenario, we designed this trial to specifically test the hypothesis that SBRT will improve clinical outcomes in select population affected by metachronous oligometastatic HSPC treated with androgen deprivation therapy + apalutamide. Enrolled patients will be randomized to receive the standard systemic treatment alone or in combination with SBRT on all metastatic sites of disease. Here we report the protocol design and an overview of the ongoing trials testing different integration strategies between RT and systemic therapies.

Keywords: Apalutamide; Metastatic hormone sensitive prostate cancer; Stereotactic body radiotherapy.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Androgen Antagonists / therapeutic use
  • Androgens
  • Humans
  • Male
  • Prostatic Neoplasms* / pathology
  • Radiosurgery* / methods

Substances

  • Androgen Antagonists
  • apalutamide
  • Androgens