UPDATE: VIR-5500 Extended into mHSPC

VIR-5500 expanded into mHSPC in April 2026, when it announced the first patient had been dosed in the Phase 1 dose-expansion cohorts. VIR-5500 is being studied in late-line mCRPC as monotherapy and, importantly for this expansion, in combination with an androgen receptor pathway inhibitor in early-line mCRPC and mHSPC. The move was built on earlier […]

UPDATE: SL-28 Phase 1/2 Trial Started To Recruit in Advanced Solid Tumors

A very interesting Phase 1/2 trial of SL‑28 has started enrolling up to 60 patients with advanced solid tumours at The Southern Oncology Clinical Research Unit (SOCRU). Although the study is open to a broad range of solid cancers, it is particularly noteworthy for prostate cancer because a published case report described a complete response […]

EvoPAR‑Prostate05 Phase 3 Trial: Saruparib Maintenance for Metastatic Hormone‑Sensitive Prostate Cancer

EvoPAR‑Prostate05 is a Phase 3 maintenance trial testing the PARP1‑selective inhibitor saruparib (AZD5305) in men with metastatic hormone‑sensitive prostate cancer (mHSPC). The trial enrolls both HRR‑mutated and non‑HRR‑mutated patients but requires that each participant has confirmed homologous recombination repair mutation status (HRRm – genes such as BRCA1, BRCA2, ATM, PALB2, CDK12, RAD51B/C/D, or BARD1), homologous […]

Phase 2 Trial: Adaptive PSMA-PET–Guided 177Lu-DOTA-HYNIC-panPSMA (TLX597-Tx) in mHSPC

The OPTIMAL-e trial is a phase 2 pilot study testing adaptive, PSMA-PET–guided radioligand therapy (RLT) with 177Lu-DOTA-HYNIC-panPSMA (TLX597-Tx) in men with metastatic hormone-sensitive prostate cancer (mHSPC), on top of standard androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPI). Conducted at St Vincent’s Hospital in Sydney, it is single-arm, open-label, and nonrandomized, designed […]

Phase 1 Trial of SHY-ONC6, a Proteasome-Modulating Therapy in Solid Tumors (Including mCRPC)

SHY-ONC6 is now entering a Phase 1 first-in-human clinical study in patients with advanced or metastatic solid tumors. The trial is open-label and multicenter, and its main goals are to assess safety, tolerability, pharmacokinetics, and early signs of anti-tumor activity in people whose disease has progressed on standard therapy or who cannot tolerate it. SHY-ONC6 […]

Rinzimetostat and Darolutamide: Himalayas-1 Phase 3 Clinical Trial

Himalayas‑1 is a newly initiated global Phase 3 registrational trial testing rinzimetostat (ORIC-944) in combination with darolutamide in men with metastatic castration‑resistant prostate cancer (mCRPC) who have previously been treated with abiraterone. The trial is designed as a pivotal study intended to support approval if the results are positive, with about 600 patients planned across […]

UPDATE: AO-252 Demonstrates 80% Clinical Benefit Rate as Development Shifts to Expansion Phase

AO-252, a first-in-class TACC3 inhibitor, continues to show early clinical promise in advanced solid tumours, with recent updates highlighting both improved efficacy through optimized dosing and a new formulation designed to enhance drug exposure. Interim data from an ongoing Phase 1/2 trial demonstrated a clear dosing-dependent effect. Transitioning from once-daily (QD) to twice-daily (BID) administration […]

Phase 3 Trial: Metformin in Men Receiving ADT for Prostate Cancer

Metformin may help blunt some of the harmful hormonal and metabolic changes caused by androgen deprivation therapy (ADT) in men with prostate cancer, according to a correlative analysis from the PRIME phase III randomized trial. ADT is a standard treatment for locally advanced and metastatic prostate cancer, but it is also associated with metabolic syndrome, […]

Soon to Start Phase 1/2 Trial: CRISPR-Edited Tregs Enter the Clinic for Solid Tumors

CRG-150, a CRISPR-edited regulatory T cell therapy has entered first-in-human testing for solid tumors, marking an unusual and potentially important step in oncology. The program is aimed at metastatic breast and prostate cancers, two settings where treatment options remain limited once disease becomes advanced. What makes this approach different is the cell type being used. […]

RIPCORD Phase 1 Trial: Interim PSMA PET–Guided Adaptive Radiotherapy in Metastatic Castration-Sensitive Prostate Cancer

RIPCORD is a UT Southwestern phase 1 trial testing a simple but important idea: can PSMA PET be used during treatment to decide how much metastasis-directed radiotherapy a patient actually needs? It focuses on men with poly-metastatic castration-sensitive prostate cancer and uses interim 68Ga-PSMA-11 PET to adapt stereotactic ablative radiotherapy (SABR) rather than giving every […]