Phase 2 OPTIMAL-e Study Begins Dosing in Metastatic Hormone-Sensitive Prostate Cancer to Assess Adaptive Lutetium-177 PSMA RLT

July 19, 2026

Urology Times USA

Overview

The Phase 2 OPTIMAL-e study has commenced dosing patients with metastatic hormone-sensitive prostate cancer (mHSPC) to evaluate an adaptive treatment approach using the investigational PSMA-targeted radioligand therapy, lutetium-177 (177Lu) DOTA-HYNIC-panPSMA (TLX597-Tx). This study aims to improve therapeutic responses and enable treatment pauses for select patients, advancing personalized treatment strategies.

In Depth

Key Findings

The Phase 2 OPTIMAL-e study has initiated patient dosing in metastatic hormone-sensitive prostate cancer (mHSPC) to assess an adaptive treatment approach utilizing the investigational PSMA-targeted radioligand therapy (RLT), Lutetium-177 (177Lu) DOTA-HYNIC-panPSMA (TLX597-Tx). This research aims to maximize therapeutic efficacy and minimize patient burden by enabling flexible adjustments to the treatment protocol based on individual patient responses.

Technical & Clinical Details

TLX597-Tx is a radioligand designed to target PSMA (prostate-specific membrane antigen), which is overexpressed on the surface of prostate cancer cells, selectively delivering the beta-emitting radionuclide Lutetium-177 (177Lu) to these cancer cells. The OPTIMAL-e study explores a strategy of adaptively adjusting the dosage and cycles of RLT based on patient’s PSMA expression levels, imaging diagnostics (e.g., PET/CT), and blood-based biomarkers (e.g., PSA). This adaptive dosing approach, which deviates from standardized fixed-dose protocols, aims to achieve optimal therapeutic effects while avoiding overtreatment and unnecessary side effects. The study will investigate the possibility of treatment pauses for specific patients showing good response, aiming to improve quality of life and reduce treatment-related toxicity.

Background & Context

Metastatic hormone-sensitive prostate cancer is often challenging to treat as the disease progresses, necessitating more effective therapies with fewer side effects. PSMA-targeted RLT has garnered significant attention recently as a promising treatment for advanced prostate cancer, but optimizing treatment, particularly through individualized dosing strategies responsive to each patient, has been a key challenge. The OPTIMAL-e study addresses this unmet medical need by applying the principles of precision medicine to RLT, thereby realizing a patient-centric treatment approach.

Strategic Significance & Outlook

The results of the Phase 2 OPTIMAL-e study are crucial for establishing the clinical utility of PSMA-targeted RLT with TLX597-Tx in mHSPC patients. If this adaptive treatment approach proves successful, it could be established as a groundbreaking method that improves treatment outcomes while simultaneously reducing treatment-related side effects and enhancing patient quality of life. Furthermore, this research will provide important insights for the development of personalized strategies for radioligand therapy in other cancer types. If TLX597-Tx receives future approval, it holds the potential to significantly transform the treatment landscape for mHSPC.

Source: https://www.urologytimes.com/view/study-to-assess-adaptive-dosed-177lu-dota-hynic-panpsma-in-mhspc

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