Functional imaging guided stereotactic ablative body radiotherapy (SABR) with focal dose escalation and bladder trigone sparing for intermediate and high-risk prostate cancer: study protocol for phase II safo trial.

BACKGROUND: Stereotactic ablative body radiotherapy (SABR) is an emerging treatment alternative for patients with localized low and intermediate risk prostate cancer patients. As already explored by some authors in the context of conventional moderate hypofractionated radiotherapy, focal boost of the index lesion defined by magnetic resonance imaging (MRI) is associated with an improved biochemical outcome. The objective of this phase II trial is to determine the effectiveness (in terms of biochemical, morphological and functional control), the safety and impact on quality of life, of prostate SABR with MRI guided focal dose intensification in males with intermediate and high-risk localized prostate cancer. METHODS: Patients with intermediate and high-risk prostate cancer according to NCCN definition will be treated with SABR 36.25 Gy in 5 fractions to the whole prostate gland with MRI guided simultaneous integrated focal boost (SIB) to the index lesion (IL) up to 50 Gy in 5 fractions, using a protocol of bladder trigone and urethra sparing. Intra-fractional motion will be monitored with daily cone beam computed tomography (CBCT) and intra-fractional tracking with intraprostatic gold fiducials. Androgen deprivation therapy (ADT) will be allowed. The primary endpoint will be efficacy in terms of biochemical and local control assessed by Phoenix criteria and post-treatment MRI respectively. The secondary endpoints will encompass acute and late toxicity, quality of life (QoL) and progression-free survival. Finally, the subgroup of high-risk patients will be involved in a prospective study focused on immuno-phenotyping. DISCUSSION: To the best of our knowledge, this is the first trial to evaluate the impact of post-treatment MRI on local control among patients with intermediate and high-risk prostate cancer undergoing SABR and MRI guided focal intensification. The results of this trial will enhance our understanding of treatment focal intensification through the employment of the SABR technique within this specific patient subgroup, particularly among those with high-risk disease, and will help to clarify the significance of MRI in monitoring local responses. Hopefully will also help to design more personalized biomarker-based phase III trials in this specific context. Additionally, this trial is expected to be incorporated into a prospective radiomics study focused on localized prostate cancer treated with radiotherapy. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT05919524; Registered 17 July 2023. TRIAL SPONSOR: IRAD/SEOR (Instituto de Investigación de Oncología Radioterápica / Sociedad Española de Oncología Radioterápica). STUDY SETTING: Clinicaltrials.gov identifier: NCT05919524; Registered 17 July 2023. TRIAL STATUS: Protocol version number and date: v. 5/ 17 May-2023. Date of recruitment start: August 8, 2023. Date of recruitment completion: July 1, 2024.

Prospective nonrandomized study of diagnostic accuracy comparing prostate cancer detection by transrectal ultrasound-guided biopsy to magnetic resonance imaging with subsequent MRI-guided biopsy in biopsy-naïve patients.

BACKGROUND: To evaluate the diagnostic efficacy in cancer prostate (PCa) of Multiparametric prostate magnetic resonance imaging (mp-MRI) targeted biopsy compared to standard systematic transrectal ultrasound-guided biopsy (TRUSGB) in biopsy-naïve patients. METHODS: A total of 168 biopsy-naïve men with clinical suspicion of PCa due to elevated PSA levels and/or an abnormal digital rectal examination were consecutively enrolled from July 2011 to July 2014. All patients underwent TRUSGB. Patients with equivocal (Pi-rads 3) or suspicious lesion (Pi-rads 4-5), were additionally biopsied using two cores, by the same operator (cognitive technique). RESULTS: Among the 168 cases, mp-MRI was equivocal for PCa (Pi-rads 3) in 46 subjects (27.4%) and suspicious (Pi-rads 4, 5) in 40 cases (23.8%). Of the 69 patients with PCa, standard TRUSGB showed Gleason ≥7 in 75% of patients with Pirads 3 and 77.8% in cases with Pirads 4-5 on mp-MRI. Among the 40 patients with Pi-rads 4-5 lesion on the MRI, cognitive mp-MRI-guided biopsy (MRCGB) detected a higher number of cases of PCa with a Gleason score equal or superior to 7 (90%) with a higher negative predictive value (97.5%) than cases with Pi-rads 3 lesion or subjects with TRUSGB alone. CONCLUSIONS: mp-MRI followed by selective biopsy seems to be a valuable tool to improve the diagnosis of intermediate and high risk PCa compared to standard TRUSGB.

Nuevos conceptos en reanimación cardiopulmonar / New concepts of cardiopulmonary reanimation

Se realiza una revisión de los cambios en las normas para el manejo del paro cardiorespiratorio (PCR) efectuados en la Conferencia Nacional en Reanimación Cardiopulmonar y Emergencias Cardíacas llevada a cabo en los EE.UU. en 1986, así como de la bibliografía reciente referente al tema. Se destaca la importancia del entrenamiento de personas no relacionadas con la medicina en las maniobras básicas de reanimación y la creación de un sistema de emergencia con personal paramédico que atienda al evento agudo lo más pronto posible. También se comentan aspectos de la teoría de la bomba torácica en relación con el masaje cardíaco externo, las indicaciones del masaje cardíaco interno y las nuevas pautas sobre uso de drogas: el uso del calcio queda restringido al PCR por hipercalemia, por hipocalcemia o por intoxicación por drogas bloqueantes de calcio; el del bicarbonato a situaciones de comprobada acidosis, maniobras muy prolongadas e hipercalemia; y el del isoproterenol sólo ante situaciones de bradiarritmias severas que no respondan a atropina. Finalmente, la desfibrilación temprana se asocia a mayor sobrevida