Aaron Hansen, MD, shares key findings from the theraPb trial in mCRPC

In an interview at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany, Aaron R. Hansen, BSc, MBBS, FRACP, sat down with Urology Times® to discuss the key findings from the theraPb trial (NCT05720130), which is assessing the safety and preliminary efficacy of ²¹²Pb-ADVC001 in metastatic castration-resistant prostate cancer (mCRPC).¹

According to the authors, “ADVC001 is a novel PSMA-targeting radioligand therapy labelled with 212Pb, an alpha-emitting payload, designed to potently kill prostate cancer cells while minimizing toxicity.”

Hansen is a medical oncologist and the medical director at the Princess Alexandra Hospital in Brisbane, Australia.

At the time of data report, 22 patients had been enrolled in the trial. The median age of participants was 73 years (range, 59 to 88). Patients in the trial received escalating doses of ²¹²Pb-ADVC001 ranging from 60 MBq to 200 MBq for up to 6 cycles.

Overall, ²¹²Pb-ADVC001 demonstrated a favorable safety profile, with no serious treatment-related adverse events nor dose-limiting toxicities reported. The most common treatment-emergent adverse events included dry mouth (59%, grade 1; 23%, grade 2%), nausea (50%, grade 1; 18%, grade 2), and fatigue (36%, grade 1; 18%, grade 2).

Early efficacy data showed that 80% of patients who received a dose of 160 MBq or greater achieved a prostate-specific antigen (PSA) decline of at least 50% from baseline. Further, 60% of patients achieved a PSA decline of at least 80% from baseline. The overall response rate per blinded independent central review was 100% in patients with RECIST v1.1-measurable lesions, which included 2 complete responses.

Dosimetry results showed low radiation exposure to normal organs with rapid clearance, suggesting a wide therapeutic window, according to Hansen.

REFERENCE

1. Hansen AR, Pattison DA, Gan CL, et al. Results from the phase Ib dose escalation of 212Pb-ADVC001 in PSMA-positive metastatic castration-resistant prostate cancer (mCRPC): The theraPb trial. Presented at: European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. Abstract 2388P. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.esmo/static/esmo2025_abstracts/2388P.html.pdf