Clinical Trial: A single-arm clinical trial on ultra-hypofractionated radiotherapy using an MR linear accelerator for prostate cancer with preserved sexual function (Japan)

Tokyo, April 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061315) titled 'A single-arm clinical trial on ultra-hypofractionated radiotherapy using an MR linear accelerator for prostate cancer with preserved sexual function (SMART pro II study)' on April 23.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Tohoku University

Condition: Condition - prostate cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study will investigate the effectiveness of radiotherapy using an MR linear accelerator to reduce the neurovascular bundle (NVB) dose in prostate cancer patients classified as very low to favorable intermediate risk according to the NCCN risk classification, who wish to preserve sexual function. The primary endpoint will be sexual function at 24 months after the start of treatment, measured by the EPIC (9-item sexual function score). Basic objectives2 - Safety

Intervention: Interventions/Control_1 - The dose will be 13 Gy per session, for a total of two sessions, resulting in a total dose of 26 Gy. The dose prescription will be set so that 95% of the CTV (urethra + 1 mm) is irradiated at a dose of 26 Gy/2 Fr (D95 prescription). However, the following dose constraints must be observed. NVB (side that can be preserved): D0.1 cc = Gender - Male Key inclusion criteria - (1) Risk classification according to NCCN guidelines: very low to favorable intermediate (2) Strong desire for preservation of sexual function and ECOG PS: 0-1 (3) Eligible for treatment with MR linear accelerator (4) No lymph node or distant metastasis on imaging (5) No history of smoking, or has quit smoking (6) Well-controlled diabetes (HbA1c =4 lesions within 5 mm of the NVB on both sides of the bilateral MRI before treatment 5) Patients with an EPIC combined sex score of 30 or less 6) Patients taking anticoagulants or antiplatelet drugs 7) Patients with psychosis or psychiatric symptoms who are deemed unable to participate in the study 8) Patients whom the principal investigator deems unsuitable for inclusion in the study Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 17 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069765

Disclaimer: Curated by HT Syndication.