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 […]

EBNK-001: Pioneering Off-the-Shelf NK Cell Therapy for Solid Tumors

EBNK-001 represents a promising advancement in cancer immunotherapy as an “off-the-shelf” allogeneic natural killer (NK) cell product designed for multi-dose administration in patients with advanced solid tumors. Unlike autologous therapies that require individual patient cell harvesting and processing, EBNK-001 leverages healthy donor-derived NK cells, enabling immediate availability without lengthy manufacturing delays. This off-the-shelf approach addresses […]

EvoPAR-PR01: Saruparib (AZD5305) Phase III Trial in Metastatic Castration-Sensitive Prostate Cancer

Saruparib (AZD5305), a next-generation PARP1-selective inhibitor, represents a promising evolution in prostate cancer therapy, particularly for metastatic castration-sensitive disease (mCSPC), through the ongoing phase III EvoPAR-PR01 trial. Unlike first-generation PARP inhibitors (PARPi) such as olaparib that target both PARP1 and PARP2, saruparib specifically inhibits and traps PARP1 on DNA damage sites, sparing PARP2 to potentially […]

FDA Clears Phase 2b Trial of Teverelix in Advanced Prostate Cancer Patients at High Cardiovascular Risk

A new phase 2b clinical trial has received FDA “study may proceed” clearance for teverelix, a long‑acting GnRH antagonist being evaluated in men with advanced prostate cancer who are at high cardiovascular risk. The trial is designed to test a dose‑optimization regimen of teverelix over a 22‑week treatment period, with the primary goal of confirming […]

SPR1020: a Promising PARP1-Selective Inhibitor in Advanced Solid Tumors (Including mCRPC)

A  first-in-human Phase 1/2 trial of SPR1020, a highly selective PARP1 inhibitor, dosed its inaugural patient, igniting hope for patients with advanced solid tumors harboring DNA repair deficiencies. This open-label, multicenter study employs a classic 3+3 dose-escalation design to pinpoint the recommended Phase II dose or maximum tolerated dose, transitioning seamlessly into expansion cohorts tailored […]

Phase 1 Trial GTB-5550, a Immunotherapy Targeting B7-H3 in Solid Tumors (Including mCRPC)

A new immunotherapy called GTB-5550 targeting B7-H3 on cancer cells has received FDA clearance for its first human trial (expected to start in the first half of 2026), offering fresh hope particularly for advanced prostate cancer patients exhausted by standard treatments. GTB-5550 is a TriKE molecule that binds natural killer (NK) cells from the immune […]

UPDATE: Phase 1 Trial for OP-3136 in mCRPC Started Recruiting

The first-in-human phase 1 trial of OP-3136, a novel orally bioavailable KAT6A/B inhibitor for solid tumors, started recruiting, with the prostate cancer cohort focusing on men with metastatic castration-resistant prostate cancer (mCRPC). This represents a significant expansion of OP-3136 beyond its initial focus on estrogen receptor-positive breast cancer, following encouraging preclinical data presented at AACR […]

Alliance A222001 Phase 2 Trial: Oxybutynin Looks Promising for Hot Flashes in Men Under ADT

The Alliance A222001 study, published in the Journal of Clinical Oncology in January 2026, found that oxybutynin, a drug typically used to treat overactive bladder, significantly reduces hot flashes in men receiving androgen-deprivation therapy (ADT), with improvements occurring within the first week of treatment and sustained throughout the study period. The findings could reshape how […]

Phase 1/2 JASPER Trial: Ruxolitinib Plus Enzalutamide for mCRPC

The JASPER trial is a phase 1/2 study launching from the University of Michigan, takes a fundamentally different approach to castration-resistant prostate cancer by targeting the molecular machinery driving cancer plasticity from the start: the JAK/STAT inflammatory signaling axis. Understanding why this strategy makes biological sense requires stepping into what we now know about how […]

ANDROMEDA Trial: Alpha vs. Beta PSMA Therapy

The ANDROMEDA phase 2 trial represents an advancement in managing recurrent oligometastatic prostate cancer by directly pitting alpha-emitting 225Ac-PSMA-617 against the established beta-emitting 177Lu-PSMA-617 (Pluvicto), both combined with stereotactic body radiotherapy (SBRT). This head-to-head comparison stems from the need to address limitations in current therapies for patients whose cancer returns in 1-5 detectable spots on […]