An Open-Label, Phase 1 Dose-finding Study to Define the Maximum Tolerated Dose and Schedule of TRP-001 as Neoadjuvant Therapy in Treatment-naïve Very High-Risk Prostate Cancer Patients Eligible for Radical Prostatectomy with Extended Pelvic Lymph Node Dissection

Condition studied

Prostate cancer

Eligibility

Primary endpoint

Incidence of DLTs after first treatment administration (DLT evaluation period).

Endpoint detail

TEAEs and TRAEs, including laboratory results, at each activity level and overall., Ability to perform prostatectomy after start of neoadjuvant treatment, duration of surgery, complication rate during and after surgery and grade of surgical difficulty., Tumour absorbed doses and absorbed doses of organs at risk assessed by imaging dosimetry and blood dosimetry after each patient’s first administration of TRP-001., Treatment efficacy will be explored based on the following: o Biochemical response rate during treatment period and up to immediately before RPE o Objective response rate from baseline to before RPE o Pathological response rate in the resected surgical specimen of the primary tumour within the prostate gland and in involved LNs, if any.