ARASTEP darolutamide/ADT study in HSPC to use Illuccix to facilitate outcome assessment

The phase 3ARASTEP study, which is evaluating darolutamide (Nubeqa; Bayer) plus androgen deprivation therapy (ADT) vs ADT alone in patients with hormone-sensitive prostate cancer (HSPC), will be using Illuccix (Telix) to facilitate the primary outcome measure of radiological progression-free survival (rPFS).¹

“The use of PSMA-PET/CT in this setting is illustrative of the potential for this imaging modality to move beyond diagnosis to a disease management tool,” said Colin Hayward, MBBS FFPM.

Illuccix is a radiopharmaceutical cold kit for the preparation of gallium-68 (68Ga) gozetotide (PSMA-11) injection, which is used for PSMA-PET imaging. In the ARASTEP trial, the primary outcome measure of rPFS is being measured by PSMA-PET/CT imaging with 68Ga-PSMA-11 (prepared using Illuccix) or piflufolastat F 18.

Overall, the ARASTEP trial of darolutamide/ADT vs ADT alone is aiming to enroll 750 patients with HSPC and high-risk biochemical recurrence (BCR).² The study design defines BCR as a rising PSA level with a doubling time of less than 12 months and no evidence of metastatic disease.

Other inclusion criteria are no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT scan at baseline. Patients are being enrolled at clinical sites worldwide, including Europe, Japan, and the United States. The estimated primary completion date is January 29, 2027.

“We are pleased to supply Bayer and a number of clinical sites in this important study, reflective of Telix's unique commitment to delivering advanced prostate cancer imaging globally. The use of PSMA-PET/CT in this setting is illustrative of the potential for this imaging modality to move beyond diagnosis to a disease management tool,” Colin Hayward, MBBS FFPM, chief medical officer, Telix, stated in a press release.¹

FDA approvals of Illuccix

The FDA initially approved Illuccix in December 2021 for use following radiolabeling with gallium-68 as a radioactive diagnostic agent for PSMA-PET imaging in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy; or with suspected recurrence based on elevated serum PSA level.³

In March 2023, the FDA expanded this approval to include the selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617; Pluvicto) PSMA-directed therapy is indicated.⁴

References

1. Telix to Supply Bayer with Illuccix® for Global Phase III Prostate Cancer Study. Published online and accessed May 8, 2023. https://prn.to/3piSRAa

2. NIH US National Library of Medicine. ClinicalTrials.gov. A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Nonmetastatic Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies (ARASTEP). NCT05794906. Last updated April 25, 2023. Accessed May 8, 2023. https://clinicaltrials.gov/ct2/show/NCT05794906

3. FDA Approves Telix’s Prostate Cancer Imaging Product, Illuccix. Published online December 20, 2021. https://telixpharma.com/news-views/fda-approves-telixs-prostate-cancer-imaging-product-illuccix

4. FDA Approves Expanded Indication for Telix's Illuccix® to Include Patient Selection for PSMA-Directed Radioligand Therapy. Published online and accessed March 16, 2023. https://prn.to/40a1v15.