In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy

Phase 2 Active not recruiting 130 enrolled Peter MacCallum Cancer Centre, Australia Advanced Accelerator Applications · collab Australasian Radiopharmaceutical Trials network (ARTnet) · collab Australia's Nuclear Science and Technology Organisation (ANSTO) · collab Australian and New Zealand Urogenital and Prostate Cancer Trials Group · collab Centre for Biostatistics and Clinical Trials (BaCT) · collab Movember Foundation · collab Prostate Cancer Research Alliance · collab United States Department of Defense · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase 2 randomised clinical trial will compare the effectiveness of Lu-PSMA therapy followed by docetaxel chemotherapy versus docetaxel chemotherapy on its own in patients with newly-diagnosed high-volume metastatic hormone-naive prostate cancer (mHNPC).

Timeline

Start: 2020-04-21
Primary completion: 2026-03
Completion: 2026-03

Publications

Azad AA, Bressel M, Tan H, Voskoboynik M, Suder A, Weickhardt AJ, Guminski A, Francis RJ, Saghebi J, Dhiantravan N, Joshua AM, Emmett L, Horvath L, Murphy DG, Hsiao E, Balakrishnar B, Lin P, Redfern A, Macdonald W, Ng S, Lee ST, Pattison DA, Nadebaum D, Kirkwood ID, Hofman MS; UpFrontPSMA Study Team. Sequential [177Lu]Lu-PSMA-617 and docetaxel versus docetaxel in patients with metastatic hormone-sensitive prostate cancer (UpFrontPSMA): a multicentre, open-label, randomised, phase 2 study. Lancet Oncol. 2024 Oct;25(10):1267-1276. doi: 10.1016/S1470-2045(24)00440-6. Epub 2024 Sep 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	177Lu-PSMA-617	Other / unclassified	7500 mbq	Intravenous
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous

In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy

Summary

Timeline

Publications

Drugs

Indications