Tolerability of Concurrent EBRT + Lu-PSMA for Node-positive Prostate Cancer (PROQURE-1)

Condition: Prostatic Neoplasm

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05162573

Sponsor: The Netherlands Cancer Institute

Phase: Phase 1


  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Histologically proven prostate cancer;
  • cT2-4, partly determined by MRI;
  • N1, determined by LND/SNP and/or PSMA PET/CT;
  • iM0, determined by PSMA PET/CT;
  • Accepted for curative intent treatment with EBRT of the prostate and regional nodes + 3y ADT;
  • Visually PSMA-positive primary tumor and nodes, largest lesion ≥ average liver uptake;
  • WHO performance score 0-1;
  • Age > 18 years;
  • 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 6 months after the study drug administration; and
  • Signed written informed consen

Exclusion Criteria:

  • Inability to comply to study procedures;
  • Inability to adhere to radiation safety measures in hospital or at home;
  • Inability to undergo the required biodistribution scans;
  • Prior or current malignant disease with potential impact on treatment outcome or survival;
  • Prior treatment with EBRT;
  • Prior treatment with ADT, already initiated >1 month before the start of EBRT;
  • Prior treatment with radionuclide therapies, 177Lu-PSMA-617 or other;
  • Reduced bone marrow reserve (Hb<6 mmol/L, Leukocytes<2.5 10E9/L, or Platelets<100 10E9/L not older than 1 month before start of EBRT);
  • Reduced renal function (GFR < 60 not older than 1 month before start of EBRT);
  • Reduced salivary gland function (history of prior salivary gland disease); or
  • Miction problems requiring pre-treatment with ADT.

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