Tokyo, Feb. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060576) titled 'A prospective study to assess the therapeutic effect of 177Lu-PSMA in patients with metastatic castration-resistant prostate cancer' on Feb. 4.

Study Type: Interventional

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

Primary Sponsor: Institute - Gunma University

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

Objective: Narrative objectives1 - To analyze the efficacy of SPECT/CT images taken after LuPSMA treatment to assess treatment efficacy. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The study subjects are mCRPC patients who have undergone LuPSMA therapy. After admission to a dedicated treatment room, patients receive the prescribed dose of LuPSMA on the day of administration and are followed overnight by observation. The following day, once the dose is confirmed to be acceptable for discharge, images are taken using a SPECT/CT scan in our hospital's radioisotope (RI) laboratory to capture images of the lesion using gamma rays emitted by LuPSMA. This will be performed after the first six treatments to assess whether it is useful for assessing treatment efficacy. Conventional tumor markers and imaging tests (CT, MRI, bone scan) will be performed at standard intervals, and comparisons with these will also be conducted.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male Key inclusion criteria - (1) Adult men aged 20 years or older (2) Patients pathologically diagnosed with prostate cancer (3) Patients with mCRPC undergoing LuPSMA therapy at our hospital (4) Patients who provide written informed consent to participate in this study Key exclusion criteria - (1) Patients who do not consent to this study or who refuse to participate Target Size - 30

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 02 Month 04 Day Date of IRB - 2026 Year 02 Month 04 Day Anticipated trial start date - 2026 Year 02 Month 04 Day Last follow-up date - 2032 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069286

Disclaimer: Curated by HT Syndication.