UPDATE 2: HLD-0915 Shows Promising Early Results in Drug-Resistant Prostate Cancer

A first-in-human clinical trial conducted at The University of Texas MD Anderson Cancer Center has revealed encouraging early results for HLD-0915, a new oral therapy designed for patients with metastatic castration-resistant prostate cancer (mCRPC). The findings, presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, indicate that HLD-0915 is well tolerated and […]

Final OS Data from EMBARK Phase 3 Trial: Enzalutamide With ADT for Men at Risk of BRPC

Data from the phase 3 EMBARK trial, combining enzalutamide with standard hormone therapy, recently published in The New England Journal of Medicine and presented at the 2025 European Society for Medical Oncology (ESMO) Congress, reveal that this combination reduces the risk of death by more than 40% over eight years compared to hormone therapy alone. […]

UPDATE About ENV-105: Promising Phase 2 Interim Results for mCRPC

The investigational drug ENV-105 (carutoximab), a first-in-class CD105 antagonist, has shown promising interim efficacy results in a Phase 2 clinical trial involving patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after standard hormone therapies. This ongoing trial evaluated the combination of ENV-105 with apalutamide, a commonly used hormone therapy. Among patients treated, 86% […]

Phase 1/2 Trial to Evaluate Gedatolisib Plus Darolutamide Combo in mCRPC

Gedatolisib, an inhibitor targeting the PI3K/AKT/mTOR pathway, in combination with darolutamide, an androgen receptor antagonist, is being evaluated as a treatment option for metastatic castration-resistant prostate cancer (mCRPC). In a phase 1/2 clinical trial, patients who had progressed on prior androgen receptor signaling inhibitors received once-weekly intravenous gedatolisib in doses of 120 mg or 180 […]

ADVC001: Lead-212 PSMA Alpha Therapy Shows Safety and Efficacy in mCRPC Trial

At the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, new clinical data from a Phase 1b dose escalation trial investigating ADVC001, a novel Lead-212-based PSMA-targeted alpha therapy for metastatic castration-resistant prostate cancer (mCRPC) was presented. The therapy utilizes a radioactive isotope, Lead-212, to deliver targeted alpha radiation to prostate cancer cells, aiming […]

Phase 3 PRESTO Trial Results: Apalutamide Extends Progression Free Survival

The PRESTO trial, a phase 3 open-label study, evaluated androgen blockade intensification in patients with high-risk biochemically relapsed prostate cancer after radical prostatectomy. This population featured rapid PSA doubling times and no detectable metastases. The study randomized 504 patients to 52 weeks of treatment with either androgen deprivation therapy (ADT) alone, ADT plus apalutamide, or […]

ENZARAD Trial Shows Selective Gains for Node-Positive Prostate Cancer With Enzalutamide Intensification

The final results of the phase 3 ENZARAD study, presented at the European Society for Medical Oncology (ESMO) Congress 2025, reveal that intensifying androgen deprivation therapy (ADT) with enzalutamide does not significantly improve metastasis-free survival (MFS) in the overall population of men with high-risk localized or locally advanced prostate cancer. Conducted across eight countries and […]

Pluvicto extends disease control in advanced hormone-sensitive prostate cancer

The Phase III PSMAddition trial presented at the 2025 European Society for Medical Oncology Congress marks a meaningful advance in the treatment of prostate cancer that still responds to hormonal therapy but has already spread to distant sites. In this study, patients with prostate-specific membrane antigen–positive metastatic hormone-sensitive prostate cancer received the radioligand therapy Pluvicto […]

Phase 1/2 AlphaBet Trial: Promising Combination of Lutetium-177 PSMA-I&T and Radium-223 in Advanced Prostate Cancer

A novel therapeutic approach combining lutetium-177 177Lu-PSMA-I&T and radium-223 (223Ra) shows encouraging results for men with metastatic castration-resistant prostate cancer (mCRPC), as demonstrated in the recently reported AlphaBet trial published in The Lancet Oncology in October 2025. This phase 1/2 AlphaBet study is the first to evaluate the safety, feasibility, and preliminary efficacy of the […]

ARASAFE Trial Offers Safer Docetaxel-Darolutamide-ADT Regimen for mHSPC

Recent data presented at the 2025 European Society for Medical Oncology (ESMO) Congress reveal a promising new treatment schedule for patients with metastatic hormone-sensitive prostate cancer (mHSPC). The phase 3 ARASAFE trial evaluated an alternative docetaxel dosing regimen combined with darolutamide and androgen deprivation therapy (ADT), showing significant reductions in severe toxicities while maintaining effective […]