Safety, Preliminary Efficacy and Pharmacokinetics of [IP] in Metastatic Castrate Resistant Prostate Cancer

Prostate cancer is on the increase globally, especially in men under the age of 50, and in 2022 there were 1.47 million new cases. The 5-year survival rate is close to 100%, largely thanks to advances in treatment and awareness of the importance of early detection.

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Trial Summary

Design: 3+3 dose escalation
Product: hydroxylase inhibitor (CYP-17 lyase inhibitor)
Sites: 6 sites (USA)
Patients: 27 patients, enrolment complete

Successes

Timely site activations
Engaged investigators and site personnel/enrolment to projected schedule/low screen failure rate
Achieved defined milestones through tightly controlled project management efforts in collaboration with the sponsor

Challenges with Mitigations

Meaningful variances were discovered between local and central results (PSA).
- CRO investigation identified root cause. Corrective actions implemented at the central lab via CAPA, including requirement for full internal investigation and lab assay re-calibration and validation, as well as sponsor lead audit supported by CRO, back-up samples were available for testing after CAPA resolved
CL designed requisitions did not match clinical database data capture specifications
- Per sponsor request to keep costs at minimum, CRO team developed data conventions for data between requisitions and data captured in EDC
Multiple protocol amendments back to back
- Multi-amendments per single local IRB submission which also resulted in fewer clinical database updates. Utilised central tracking system to ensure amendments appropriately distributed, submitted and approved.
Elevated LFT’s noted during dose escalation
- Close management of safety lab conduct, results provided near real-time to medical team for review, assessment and decision