Penile Cancer

Key advances include: (1) In bladder cancer, perioperative durvalumab (NIAGARA) and enfortumab vedotin plus pembrolizumab (KEYNOTE-905/EV-303) set new standards, while HER2-targeted disitamab vedotin plus toripalimab (RC48-C016) improved metastatic survival...(3) In prostate cancer, enzalutamide plus leuprolide improved survival in high-risk biochemical recurrence (EMBARK). Capivasertib plus abiraterone benefited PTEN-deficient metastatic hormone-sensitive disease (CAPItello-281). The PSMAddition trial demonstrated that adding [177Lu]Lu-PSMA-617 to standard therapy significantly improved radiographic PFS in PSMA-positive mHSPC. Docetaxel scheduling was optimized (ARASAFE), and an AI model (STAMPEDE) identified patients for AR inhibitor benefit. Novel agents like saruparib and pasritamig showed promise...The 2025 evidence establishes multiple new standards of care across GU cancers, emphasizing biomarker-driven strategies, immunotherapy integration, novel resistance mechanisms, and treatment optimization. This synthesis provides an evidence-based framework for updating guidelines and highlights the move toward more personalized management, while noting persistent challenges and future research needs.

P2, N=25, Recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

P=N/A, N=80, Recruiting, University Hospital Tuebingen | Not yet recruiting --> Recruiting

P2, N=28, Recruiting, Instituto do Cancer do Estado de São Paulo | Active, not recruiting --> Recruiting

P1, N=32, Completed, Baylor College of Medicine | Active, not recruiting --> Completed | Trial completion date: Oct 2033 --> Jan 2026

P=N/A, N=72, Completed, Travera Inc | Recruiting --> Completed | N=200 --> 72 | Trial completion date: Jul 2028 --> Mar 2026 | Trial primary completion date: Jul 2027 --> Mar 2026

Taken together, this study demonstrates the prognostic value of the TIME using the three widely available markers CD3, CD8, and PD-L1 in PSCC. Furthermore, it provides additional evidence for a survival benefit of p16INK4A positive cases, compared to p16INK4A negative cases.

P1, N=10, Recruiting, Jiyan Liu | Not yet recruiting --> Recruiting | Initiation date: Jul 2025 --> Feb 2026

A prospective, non-randomized, two-cohort study was designed to evaluate the efficacy of sintilimab combined with chemotherapy in this setting...This preliminary analysis demonstrates that ICI combined with chemotherapy provides durable antitumor activity and a manageable safety profile as neoadjuvant and/or adjuvant therapy for locally advanced PSCC. These results warrant further validation in larger cohorts.

A paclitaxel, ifosfamide, and cisplatin-based regimen achieves response rates around 65%...Compared to standard chemotherapy (e.g. cisplatin, 5-FU, ifosfamide, irinotecan), treatment with romidepsin, quisinostat (HDAC inhibitors (i)), palbociclib (CDK4/6i), or 17-AAG and PU-H71 (HSP90i) reduced cell viability, induced apoptosis, and led to G2 / M cell cycle arrest in most PeCa cells. This research underscores the therapeutic potential of using HDAC, CDK4/6, and HSP90 inhibitors for PeCa management and reveals additional promising targets and biomarkers for future strategies.

P2, N=20, Not yet recruiting, Fudan University