Lara, Pedro CRodriguez-Melcon, Juan IPalacios-Eito, AmaliaLozano, AntonioHervas-Moron, AsuncionVillafranca, ElenaGomez-Iturriaga, AlfonsoSancho, GemmaMaldonado, Xavier2023-05-032023-05-032022-06-01Lara PC, Rodríguez-Melcón JI, Palacios-Eito A, Lozano A, Hervás-Morón A, Villafranca E, et al. Phase II Study of ENZAlutamide Combined With Hypofractionated Radiation Therapy (ENZART) for Localized Intermediate Risk Prostate Cancer. Front Oncol. 2022 Jul 14;12:8918862234-943Xhttp://hdl.handle.net/10668/20683Intermediate-risk prostate cancer (PCa) is usually treated by a combination of external beam radiation therapy (EBRT) and a short course of androgen deprivation therapy (ADT). ADT is associated with multiple side effects, including weight gain, loss of libido, and hot flashes. In contrast, anti-androgen monotherapy is generally better tolerated in spite of higher rates of gynecomastia. This study assessed the effectiveness of enzalutamide monotherapy combined with hypofractionated EBRT (Hypo-EBRT) for treating intermediate risk prostate cancer. This trial was a multicenter, open-label phase II study of 6 months of enzalutamide monotherapy combined with Hypo-EBRT for intermediate-risk prostate cancer. Hypo-EBRT was initiated 8-12 weeks after initiating enzalutamide. The primary endpoint was PSA decline >80% measured at the 25th week of enzalutamide administration. Secondary end-points included assessment of toxicity, changes in anthropomorphic body measurements, sexual hormones, and metabolic changes. Sixty-two patients were included in the study from January 2018 to February 2020. A PSA decline of >80% was observed in all evaluable patients at the end of enzalutamide treatment and 92% achieved PSA values under 0.1 ngr/ml. All patients remain in PSA response (80% was observed in all evaluable patients at the end of enzalutamide treatment and 92% achieved PSA values under 0.1 ngr/ml. All patients remain in PSA response ( Enzalutamide monotherapy is very effective along with hEBRT in reducing PSA levels for patients with intermediate-risk prostate cancer. Longer follow-up is needed to confirm the potential use of this combination in future randomized trials.enAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/Enzalutamide monotherapyHypofractionatedIntermediate riskProstate cancerRadiotherapyresearch article35912190open access10.3389/fonc.2022.891886PMC9329530https://www.frontiersin.org/articles/10.3389/fonc.2022.891886/pdfhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9329530/pdf