Condition: Prostatic Neoplasm

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05162573

Sponsor: The Netherlands Cancer Institute

Phase: Phase 1

Eligibility:

• 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.

View trial on ClinicalTrials.gov