A phase II, single arm two-phase, clinical study of individually adapted systemic radioligand therapy with 177Lu-PSMA I&T for patients with metastatic, castration-resistant prostate cancer

Prior treatment

• Prior treatment radiopharmaceutical agents for prostate cancer
• Concurrent cytotoxic chemotherapy, immunotherapy, other isotope treatment, PARP inhibitor, biological, or investigational therapy
• Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers, or superficial bladder cancer unless disease-free for ≥ 3 years.
• Radiotherapy or chemotherapy within 2 months prior to planned treatment

Other illness

• Major medical or psychiatric illness, which in the investigator’s opinion, would prevent completion of treatment and would interfere with follow-up.
• Serious hematologic, renal or CNS illness that in the opinion of the investigator would preclude study participation
• Cardiovascular disease (severe symptomatic coronary artery disease, congenital heart failure, class 3 and 4 of the New York heart association functional classification, NYHA)

Other

• Urinary tract obstruction, or uncontrollable urine incontinence, or marked hydronephrosis
• Superscan on bone scan
• Brain metastases, uncontrolled symptomatic or asymptomatic
• Symptomatic cord compression

• Histologically confirmed adenocarcinoma of the prostate
• PSMA-positive, castration resistant prostate cancer with serum testosterone ≤ 1.7 nmol/L
• At least one ARPI (such as enzalutamide or abiraterone), and one previous taxane treatment, or not eligible for taxane treatments
• Progressive disease defined as one of the following: a. New lesions or significant tumor growth on any of the following radiological scans; BS, CT, 18-DCFPyL-PSMA-PET (18F-PSMA) or 18F-PET/CT b. Rising PSA defined as: - Consecutive increase in PSA, determined by two separate measurements taken at least 1 week apart and confirmed by a third, and if necessary, measurement, - PSA ≥ 5 ng/mL and ≥ 25% above the previous nadir
• WHO/ECOG performance status 0-2. (See Appendix A)
• Patient must be ≥ 18 years of age
• Expected survival > 6 months
• Measurable bone or visceral metastasis confirmed with PSMA-PET/CT