ESTRO 2024 - Abstract Book

S2390

Clinical - Urology

ESTRO 2024

1 H. Universitario Ramón y Cajal, Radiation Oncology, Madrid, Spain. 2 H. Universitario La Princesa, Radiation Oncology, Madrid, Spain. 3 H. Universitario Santiago de Compostela, Radiation Oncology, Santiago de Compostela, Spain. 4 H. Ruber Internacional, Radiation Oncology, Madrid, Spain. 5 Complejo Hospitalario de Pamplona, Radiation Oncology, Pamplona, Spain. 6 H. Universitario Virgen de la Candelaria, Radiation Oncology, Tenerife, Spain. 7 Instituto Oncológico IMQ, Radiation Oncology, Bilbao, Spain. 8 H. Universitario Torrecárdenas, Radiation Oncology, Almeria, Spain. 9 H. Quirón Madrid, Radiation Oncology, Madrid, Spain. 10 H. Universitario Virgen de la Victoria, Radiation Oncology, Málaga, Spain. 11 H. Universitario Rey Juan Carlos, Radiation Oncology, Madrid, Spain. 12 H. Universitario San Juan, Radiation Oncology, Alicante, Spain. 13 H. Quirón La Luz, Radiation Oncology, Madrid, Spain. 14 H. Universitario Virgen de la Arrixaca, Radiation Oncology, Murcia, Spain. 15 H. Universitario San Cecilio, Radiation Oncology, Granada, Spain. 16 H. Regional Carlos Haya, Radiation Oncology, Málaga, Spain. 17 H. Universitario de Gran Canaria Dr. Negrín, Radiation Oncology, Las Palmas de Gran Canaria, Spain. 18 H. Universitario de Fuenlabrada, Radiation Oncology, Madrid, Spain. 19 Fundación Jiménez Díaz, Radiation Oncology, Madrid, Spain. 20 H. Universitario Gregorio Marañón, Radiation Oncology, Madrid, Spain. 21 H. Santa Creu i Sant Pau, Radiation Oncology, Barcelona, Spain. 22 H. Universitario Ramón y Cajal, Data Science Unit, Madrid, Spain

Purpose/Objective:

HYPORT-ES (ClinicalTrials.gov Identifier: NCT04484038) is a collaborative (URONCOR, GICOR and SEOR) prospective multicenter phase II trial testing hypofractionated postoperative radiotherapy in prostate cancer. We presented the results of acute and late gastrointestinal (GI) and genitourinary (GU) toxicity, biochemical control, and quality of life (QoL)

Material/Methods:

Moderate hypofractionated postoperative radiotherapy (adjuvant and salvage radiotherapy indication according to international guidelines definition) was administered to evaluate the feasibility (efficacy and safety) of this scheme. The radiation dose used was 62.5 Gy in 25 fractions of 2.5 Gy/fraction, EQD2= 70 Gy. The inclusion criteria included the presence of unfavourable pathological factors (pT3 and/or positive surgical margins) and/or biochemical failure (PSA ≥ 0.2 ng/ml). Prophylactic nodal irradiation was not allowed. IMRT and IGRT was mandatory. Risk adapted androgen deprivation therapy was permitted. The main outcome measure was acute and late genitourinary (GU) and gastrointestinal (GI) toxicity according to CTCAE. v5 criteria. Secondary outcomes were biochemical control, metastasis-free survival, overall survival and quality of life (EPIC-26, I-PSS and QLQ-30 questionnaires) evaluated before starting radiotherapy and at 6, 12 and 24 months after the end of treatment.

Results:

From 07/2019 to 07/2022 407 patients from 25 Spanish centers were recruited. Median follow-up was 21 months (range 2-62 months). Median age was 68 years (range 48-83 years), 42% of the patients were pT3 and 62% had positive margins. The indication for postoperative RT was adjuvant in 19% and salvage in 81% of the cases. Median PSA pre-RT was 0.28 ng/ml (0-2 ng/ml). 54% of the patients were treated with concomitant androgen deprivation therapy. The 2-year biochemical relapse-free survival was 92%. Acute GU and GI toxicity G2 was observed in 7% and 1% of the patients respectively, with only 1% of G3 acute GU toxicity. Late GU and GI toxicity G2 was reported in 10% and 1.2% of the patients respectively. Late GU toxicity G3 was observed in 1.7% and late GI toxicity G3 in 0.8% of the patients. In relation to QoL 2/3 of the patients improved or maintained the same scores in the 3 questionnaires evaluated.