Penile Cancer

P1/2, N=143, Active, not recruiting, Transgene | Trial completion date: Dec 2025 --> Dec 2026

Overall, we investigated the heterogeneity of TME from a single-cell perspective and demonstrated that SEMA3C serve as an effective biomarker for predicting lymph node metastasis and prognosis in PSCC. These findings may offer valuable insights for future therapeutic strategies.

P2, N=47, Not yet recruiting, Sun Yat-sen University

P=N/A, N=80, Not yet recruiting, University Hospital Tuebingen

P=N/A, N=20, Not yet recruiting, The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Soochow University

This study provides the first evidence of molecular changes in peritumour tissue to demonstrate field effect in PeSCC, characterised by downregulation of Wnt4, upregulation of c-MYC, and altered spatial colocalisation of Wnt-related proteins in cancer-adjacent skin. These findings suggest that peritumoral tissues exhibit early molecular alterations that extend beyond the morphologically defined tumour margin. Recognising these changes may have implications for understanding tumour microenvironment conditioning and for the future development of biomarkers relevant to margin assessment in penile carcinogenesis.

P2, N=157, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2028 | Trial primary completion date: Dec 2025 --> Dec 2028

Immune cell density and spatial organization within the TIME are associated with survival outcomes in PSCC. Favorable patterns involving helper T cells and M1 macrophages correlate with improved survival, whereas clustering of M2 macrophages is associated with poorer outcomes, supporting the relevance of spatial immune profiling in this disease.

The absence of the common MEC-associated fusion gene may indicate a more aggressive clinical course. Further accumulation of cases with detailed molecular characterization is crucial to clarify the pathogenesis, behavior, and optimal management strategies for this rare entity.

Lastly, rare case reports of primary penile melanoma in situ have been reported. The lesions can involve either the skin or mucosa, with the glans penis being the most commonly reported site.

P2, N=100, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: May 2026 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Jun 2026

HPV-associated PSCC had a more severe loss (91%) than HPV-associated PeIN (39%) (P=0.008). These findings suggest that GATA3 alterations may be an early event during tumorigenesis, and that this marker may represent a useful complement to p16 and p53 in the differential diagnosis of HPV-independent PeIN from benign mimickers.