Study design
toxicity, prostate adenocarcinoma
RECURRENT PROSTATE CANCER, SECONDARY, PROSTATE ADENOCARCINOMA
The study was designed as a single site, prospective, non-randomized, phase I, classical 3+3 dose escalation trial of viral particles (vp). This trial was designed to enroll 15–30 men with locally recurrent prostate cancer after definitive radiotherapy under 5 cohorts with increasing doses. Each cohort of three patients with clinically localized recurrent prostate adenocarcinoma were intraprostatically injected with increasing doses (cohort-1 1x10The primary endpoint of this investigator-initiated phase-I study was to determine the dose-dependent toxicity and maximum tolerated dose (MTD) of oncolytic adenovirus-mediated cytotoxic and IL-12 gene therapy in men with locally recurrent prostate cancer after definitive radiotherapy. Secondarily we evaluated PSA response including PSA doubling time (PSADT) before and after administration of the study therapy. The exploratory aim was to determine a possible association between the primary and secondary outcomes and immunological endpoints including serum IL-12 and IFN-γ levels, and NK cell cytolytic activity. The protocol received all required regulatory approvals before initiation and was conducted under BB-IND 16536 (IRB-9829; Clinical Trials # NCT02555397). Good clinical practices were used throughout.