How to cite: Crawford ED; Hafron, JM. “SYNC-T: An Investigational In-Situ Immunotherapy Approach in Prostate Cancer.” Grand Rounds in Urology. October 2026. Accessed Oct 2026. https://grandroundsinurology.com/sync-t-an-investigational-in-situ-immunotherapy-approach-in-prostate-cancer/
Summary
In this UroDummies discussion, E. David Crawford, MD, Editor-in-Chief of Grand Rounds in Urology and Professor of Urology at the University of California, speaks with Jason M. Hafron, MD, Michigan Institute of Urology/Solaris Health, St. Clair Shores, Michigan, about SYNC-T, an investigational in-situ immunotherapy approach that combines focal cryolysis with intratumoral administration of an immune therapy formulation. Hafron explains the procedure, its proposed mechanism, early clinical experience, and ongoing Phase 2A evaluation.
Dr. Hafron describes SYNC-T as a two-step process. First, a targeted soft-tissue lesion undergoes intentionally subablative focal cryolysis using a single freeze-thaw cycle. The objective is to create a small area of immunogenic tumor necrosis that releases tumor antigens while preserving surrounding vasculature and lymphatic drainage. Through the same access, the proprietary drug SV-102 is then infused into the cryolysis zone.
The conversation reviews preliminary clinical experience. Hafron describes an initial 15-patient, single-site, investigator-initiated study conducted outside the United States in a mixed population that included patients with metastatic and metastatic castration-sensitive prostate cancer. He reports an 87% objective response rate and corrects the complete response rate to 40%. Hafron cautions that the study lacked independent central review, used a fixed dose, and should be considered hypothesis-generating rather than a benchmark for efficacy.
A subsequent US Phase 1 study treated nine patients. Hafron reports that a Phase 2A study targeting 52 patients is now evaluating two dose levels. He also describes assessing systemic activity by treating one lesion while retaining an untreated measurable site. Dr. Crawford and Dr. Hafron discuss the potential role of this investigational strategy in stimulating systemic immune activity through localized treatment.