Quantitative Unified Assessment of Novel Triplet therapy and Unconventional Maintenance with Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate Cancer: A Phase II Pilot Trial

Condition studied

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Investigational medicinal product(s)

Eligibility

Primary endpoint

The primary endpoint for this study is treatment compliance, measured as the total number of cycles administered to each patient. Patients will be categorized in two groups, complete treatment compliance (complete ≥5 cycles of Ra223) and incomplete treatment compliance (complete <5 cycles of Ra223). The proportion of patients in each category and their 95% confidence interval (CI) calculated by Clopper-Pearson will be given.

Endpoint detail

Prostate-specific antigen (PSA) response rates, defined as PSA <0.02 ng/mL at Ra223 completion., Total alkaline phosphatase response, defined as a reduction of ≥30% from the baseline value., Radiographic progression-free survival (rPFS) according to the definition of the Prostate-Cancer Clinical Trials Working Group 3 (PCWG3), Time to symptomatic skeletal event (TTSE), Time to pain progression (TTPP) according to Brief Pain Inventory (BPI), Time to next systemic antineoplastic therapy (TTNT), Time to castration resistance (TTCR), Overall survival (OS), Health-related quality of life (HRQoL), assessed through the EQ-5D-5L, and the National Comprehensive Cancer Network (NCCN) Functional Assessment of Cancer Therapy - Prostate (FACT-P)., Adverse events (AE) any grade and grade 3-5 according to Common terminology criteria for adverse events (CTCAE) v6.0, Treatment-related AEs (TRAEs) of any grade and grade 3-5 according to CTCAE V6.0, Incidence, rate and time to bone fractures., Number of dose interruptions and their cause.