An open-label, two-part, phase 2 clinical trial to investigate the safety and diagnostic performance of uPAR PET imaging for non-invasive classification of ISUP grades among patients with localised, untreated prostate cancer.

Prostate Cancer

Part 1: SUVmax at 30, 60, and 120-min. post-injection, Part 2: SUVmax in PET acquisitions at 60 min p.i. of 200 MBq.

Part 1: SUVmax in PET acquisitions at 60 min post-injection on days 1 and 8., Part 1: Evaluate PK parameters Cmax, Tmax, AUC, Vd, clearance, T1/2 from periodic radioactive counts from whole blood plus the elimination of 64Cu DOTA AE105 into a pooled urine sample to determine activity per mL which will be extrapolated to the mass dose (pg/mL) of IMP., Part 1: SUVmax in PET acquisitions at 30, 60 and 120 min p.i., Part 1: Tumour visibility (numerical rating scale [NRS], 0–2 rating) in PET acquisitions at 30, 60 and 120 min p.i., Part 1: a) SUVmax centred around 60 min p.i. with reconstructions of 3-, 5-, 10-, 20-, 30-, and 40-min frame durations in the 200 MBq cohort. b) Tumour visibility (NRS 0–2 rating) centred around 60 min p.i. with reconstructions of 3-, 5-, 10-, 20-, 30, and 40-min frame durations in the 200 MBq cohort., Part 2: SUVmax in PET acquisitions at 60 min p.i., Part 2: Tumour visibility (NRS 0–2 rating) in PET acquisitions at 60 min p.i., Part 2: SUVmax in PET acquisitions at 60 min p.i., Part 2: Tumour visibility (NRS 0–2 rating) in PET acquisitions at 60 min p.i.

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Denmark, Germany, Sweden