Tag Archive for: Pluvicto

UPDATE: Phase 3 Pivotal Trial for 177Lu-NYM032

A PSMA-targeted radioligand built on a compound called NYM032 is heading into the pivotal phase 3 trial that will decide whether its early data hold up. The molecule can be labeled with gallium-68 for PET imaging or lutetium-177 for therapy, giving a matched diagnose-and-treat pair. In mouse tumor models, escalating the dose from 18.5 to […]

Pluvicto Moves Into First-Line Metastatic Prostate Cancer, Marking Shift Toward Earlier Radioligand Therapy

A new regulatory approval is reshaping the treatment landscape for metastatic hormone-sensitive prostate cancer (mHSPC), bringing radioligand therapy into much earlier stages of disease. Pluvicto (lutetium Lu-177 vipivotide tetraxetan aka 177Lu-PSMA-617), a therapy targeting prostate-specific membrane antigen (PSMA), can now be used in combination with standard androgen deprivation therapy and androgen receptor pathway inhibitors in […]

Phase 2 Trial for Xaluritamig in Patients With mCRPC and Suboptimal Response to Pluvicto

Thomas Jefferson University is running a phase 2 study of xaluritamig, also known as AMG 509, in adults with metastatic castration-resistant prostate cancer whose disease has shown a suboptimal response to Lu-177 vipivotide tetraxetan (aka 177Lu-PSMA 617) the radioligand therapy better known as Pluvicto. The trial reflects a very specific and clinically important question: what […]

Phase 1 Trial for a New PSMA Radioligand 177Lu‑PSMA‑VG01

177Lu‑PSMA‑VG01 is a next‑generation, small‑molecule PSMA‑targeting radiopharmaceutical designed to refine what 177Lu‑PSMA‑617 (Pluvicto) has already achieved. It uses a high‑affinity ligand to deliver the beta‑emitter lutetium‑177 directly to PSMA‑expressing tumor cells, aiming for greater tumor dosing with less exposure of healthy tissue. A new phase 1 trial is testing its dosimetry and side effects on […]

Zanzalintinib After Pluvicto in Chemo‑Naïve mCRPC

Zanzalintinib is being tested after Pluvicto (177Lu-PSMA-617) in metastatic castration‑resistant prostate cancer (mCRPC) because it targets several escape routes tumors use once they have survived PSMA‑directed radioligand therapy and prolonged AR pathway blockade. Pluvicto delivers beta radiation to PSMA‑expressing cells, inducing DNA damage and tumor cell death, but progression still occurs and is often driven […]

VECTRA-01 Phase 3 Trial Tests Alpha-Emitting AZD2265 in PSMA-Positive mCRPC

A pivotal Phase 3 trial called VECTRA-01 has launched to evaluate AZD2265 (²²⁵Ac-PSMA-I&T), an alpha-emitting radioligand therapy targeting PSMA-positive metastatic castration-resistant prostate cancer. The study began in May 2026, enrolling approximately 670 participants across 90 global sites, with recruitment currently active at select locations. The trial’s primary objective is to demonstrate superiority over standard of […]

Phase 3 PSMAddition Trial Reports Positive Outcomes for mHSPC

Results from the PSMAddition trial were published in a phase 3 setting and showed several clear numbers worth noting. The trial compared standard double hormone-based treatment alone (ADT + ARPI) versus the same treatment plus a PSMA-targeted radioligand therapy (Pluvicto), in men with metastatic hormone-sensitive prostate cancer.The biggest headline was a 58% lower risk of […]

ctDNA and Fragmentomics Reveal New Predictors of Survival in 177 Lu-PSMA–617 mCRPC

Metastatic castration-resistant prostate cancer (mCRPC) remains one of the most challenging stages of prostate cancer, marked by poor prognosis and limited durable treatment options. The radioligand therapy 177Lu-PSMA-617 (Pluvicto) has emerged as a significant advance, demonstrating an overall survival benefit in selected patients. However, clinical responses vary widely, highlighting an urgent need for biomarkers that […]

Genomic Alterations and LuPSMA Outcomes in mCRPC: A Prognostic Insight

Genomic alterations like TP53, PTEN, and RB1 mutations are prevalent in metastatic castration-resistant prostate cancer (mCRPC), yet their impact on response to 177Lu-PSMA-617 (LuPSMA, Pluvicto) radioligand therapy remains underexplored. A recent retrospective study published in the Journal of Nuclear Medicine analyzed 72 mCRPC patients treated with at least one cycle of LuPSMA between October 2022 […]

Phase 1/2 ACRES Trial: Pioneering 225Ac-rhPSMA-10.1 for Post-Lutetium mCRPC

The ACRES trial represents a promising step forward in targeted alpha therapy for metastatic castration-resistant prostate cancer (mCRPC), focusing on Actinium-225-labeled radiohybrid PSMA-10.1 (225Ac-rhPSMA-10.1) in patients who have largely progressed after Lutetium-177 PSMA therapy. This multi-site, open-label Phase 1/2 study addresses an urgent need in advanced prostate cancer, where effective post-Lu-PSMA options remain limited despite […]