Pluvicto (lutetium Lu 177 vipivotide tetraxetan)

P1, N=355, Recruiting, Janssen Research & Development, LLC | N=250 --> 355

P2, N=7, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Apr 2029 --> Oct 2026 | Trial primary completion date: Apr 2029 --> Oct 2026

P1, N=101, Active, not recruiting, Endocyte | Recruiting --> Active, not recruiting

P3, N=3360, Recruiting, University College, London | N=346 --> 3360

P1/2, N=22, Recruiting, Universitaetsklinikum Essen AR | -> Recruiting | Phase classification: PN/A --> P1/2

P2, N=60, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Over a period of 10 y, our center treated 766 patients with prostate cancer using 177Lu-PSMA (177Lu-PSMA-617 or 177Lu-PSMA I&T)...Two patients received complement inhibition with eculizumab, which improved hematologic features without meaningful renal recovery. 177Lu-PSMA-associated TMA is a rare but a potentially severe complication of treatment. The contribution of initial versus cumulative renal absorbed dose remains unclear, and early dosimetry may help identify at-risk patients.

Pathway analysis reveals that p53 upregulation associates with poor PFS and OS, while an activated E2F pathway unexpectedly portends better PFS and OS. These findings support the integration of liquid biopsy proteomics into biomarker-driven mCRPC trials to improve patient stratification.

P2, N=138, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Nov 2028 --> May 2028 | Trial primary completion date: Jan 2028 --> Jul 2027

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=40, Suspended, M.D. Anderson Cancer Center | Initiation date: Dec 2025 --> Aug 2025 | Recruiting --> Suspended

In the hormone-sensitive setting (mHSPC), the combination of androgen deprivation therapy (ADT) with androgen receptor pathway inhibitors (ARPI) or abiraterone + prednis(ol)one (Abi), optionally combined with docetaxel, represents the current standard of care...Radioligand therapy with lutetium (177Lu) vipivotide tetraxetan has also gained increasing importance. It is indicated for mCRPC after prior treatment with ARPI/Abi and taxane chemotherapy, and may already play a role in the first-line mCRPC setting following treatment with darolutamide + ADT + docetaxel in mHSPC. This article presents current guideline recommendations for mHSPC and mCRPC, summarizes the underlying evidence, and provides practical guidance for treatment selection based on prior therapy and individual genetic profiles in order to support optimal decision-making in an increasingly complex therapeutic landscape.