UPDATE: LUNAR Trial Follow-Up Strengthens Case for Earlier PSMA Radioligand Therapy

Longer follow-up from the randomized phase 2 LUNAR trial suggests that PSMA-targeted radioligand therapy may do more than simply delay progression when used early in men with oligorecurrent hormone-sensitive prostate cancer. LUNAR enrolled 92 men whose prostate cancer had returned after previous treatment, with one to five metastases visible on PSMA PET/CT. Importantly, patients were […]

UPDATE: VIR-5500 Receives FDA Fast Track Designation Following Promising Phase 1 Results in mCRPC / mAPMR

The US Food and Drug Administration (FDA) has granted Fast Track designation to VIR-5500 (formerly AMX-500), an experimental immunotherapy for patients with heavily pretreated metastatic castration-resistant prostate cancer (mCRPC). The designation is intended to accelerate clinical development and regulatory review, but does not constitute drug approval. VIR-5500 is a bispecific T-cell engager designed to direct […]

Phase 1 Trial for KMV002, a New Prostate Cancer Vaccine for mCRPC

A new phase 1  clinical trial will investigate KMV002, an experimental therapeutic cancer vaccine for patients with metastatic prostate cancer that has become resistant to androgen-targeting treatments (mAPMR, previously mCRPC). Patients will receive either five or six doses of KMV002, a combination of SN3001C and an immune-stimulating substance known as a CpG ODN adjuvant. KMV002, […]

UPDATE: ENV-105 Extends Median PFS to 17.7 Months in mCRPC

We updated you about the positive results of carotuximab (ENV-105) in this previous post. Now phase 2 data suggest that ENV-105 combined with apalutamide may substantially delay progression in metastatic castration-resistant prostate cancer (mCRPC) compared with apalutamide alone. In the randomised study, median progression-free survival reached 17.7 months with ENV-105 plus apalutamide, compared with just […]

Phase 3 Trial for 177Lu-ludotadipep Radioligand Therapy for mCRPC

A new phase 3 trial is testing 177Lu-ludotadipep (177Lu-FC705 or, simply, FC705), an experimental PSMA-targeted radioligand therapy for metastatic castration-resistant prostate cancer (mCRPC). Unlike 177Lu-PSMA-617 (Pluvicto), ludotadipep includes an albumin-binding component designed to keep the radioligand in circulation longer and increase radiation delivery to PSMA-positive tumours. Earlier studies suggest that this strategy may allow substantial […]

Phase 2/3 Trial Will Test BAT Followed by Darolutamide

A newly registered randomised phase 2/3trial will test an unusual strategy in metastatic androgen pathway modulation-resistant prostate cancer (mAPMR; formerly mCRPC or castration-resistant prostate cancer): deliberately exposing resistant cancer cells to very high testosterone levels before attacking the androgen receptor again with darolutamide. The study plans to enrol 432 patients with mCRPC who have already […]

Phase 1/2 Trial: REGN21353 Plus Nezastomig STEAP1×CD3 and PSMA×CD28 Combination Enters mCRPC Trials

A new phase 1/2 trial will test REGN21353, a STEAP1×CD3 bispecific antibody, alone and in combination with nezastomig (REGN5678), a PSMA×CD28 costimulatory bispecific, in previously treated metastatic castration-resistant prostate cancer mCRPC (metastatic androgen pathway modulation-resistant prostate cancer mAPMR). The approach combines two different prostate cancer antigens and two complementary immune signals: CD3-mediated T-cell activation through […]

Phase 2 SOAR Trial: Treating Oligorecurrent Prostate Cancer Without ADT Shows Promise

The phase II SOAR trial suggests that metastasis-directed therapy (MDT) alone may delay the need for androgen deprivation therapy in carefully selected men with PET-defined oligorecurrent prostate cancer. Twenty patients with up to ten nodal or bone metastases after radical prostatectomy received radiotherapy, salvage lymph-node dissection, or both, without concurrent ADT. At six months, 40% […]

Phase 2/3 Trial For 68Ga-DOTA-RM2: GRPR-Targeted PET Could Open the Door to a New Theranostic Platform

PSMA has transformed prostate cancer imaging and radioligand therapy, but it is not the only useful target on prostate cancer cells. A new pivotal trial, SPARROW, is now testing 68Ga-DOTA-RM2, a PET tracer that targets the gastrin-releasing peptide receptor, or GRPR, in men with prostate cancer. The study is designed to determine how accurately GRPR-PET […]

Carboplatin Shows Activity in HRR-Altered Metastatic Prostate Cancer

Platinum chemotherapy is not usually considered a standard targeted treatment for metastatic prostate cancer, but the phase 2 CIPHER trial suggests that carboplatin may have meaningful activity in men with mCRPC carrying homologous recombination repair (HRR) mutations. The study enrolled 39 patients with HRR-altered mCRPC who had already received at least one androgen-receptor pathway inhibitor […]