Table 1 Inclusion and exclusion criteria

Histologically proven prostate cancer

Inability to comply to study procedures

cT2-4, partly determined by MRI

Inability to adhere to radiation safety measures in hospital or at home

N1, determined by LND/SNP and/or PSMA PET/CT

Inability to undergo the required biodistribution scans

iM0, determined by PSMA PET/CT

Prior or current malignant disease with potential impact on treatment outcome or survival

Accepted for curative intent treatment with EBRT of the prostate and regional nodes + three years ADT

Prior treatment with EBRT

Visually PSMA-positive primary tumour and nodes, largest lesion > average liver accumulation

Prior treatment with ADT, already initiated > one month before the start of EBRT

WHO performance score 0–1

Prior treatment with radionuclide therapies, [¹⁷⁷Lu]Lu-PSMA-617 or other

Age > 18 years

Reduced bone marrow reserve (Hb < 6 mmol/L, Leukocytes < 2.5 10E9/L, or Platelets < 100 10E9/L not older than one month before start of EBRT)

For patients who have partners of childbearing potential: Willingness to use a method of birth control with adequate barrier protection during the study and for six months after the study drug administration

Reduced renal function (GFR < 60 ml/min/1,73m² not older than one month before start of EBRT)

Signed written informed consent

Reduced salivary gland function (history of prior salivary gland disease)

Urinary problems requiring pre-treatment with ADT^a