Radiometabolic Therapy With 177Lu PSMA in PSMA PET/CT Positive Advanced/Metastatic Tumours:

Inclusion

• absolute neutrophil count ≥ 1,500/μL
• A female participant is eligible to participate if she is not pregnant and not breastfeeding. If female of childbearing potential highly effective birth control methods, according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials", (See Appendix F) are mandatory. Highly effective birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 6 months after final study drug administration. Two acceptable methods of birth control thus include Condom (barrier method of contraception) and one of the following is required ( established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam/gel/film/cream/suppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg., bilateral orchiectomy), for more than 6 months;
• Patients must have histologically or cytologically confirmed advanced/metastatic solid tumors; any other tumor types documented as PSMA-positive that may benefit from receptor radionuclide therapy and for which there aren't any other effective treatments. For cerebral PSMA-positive tumors, if biopsy is no feasible for technical reasons or risk benefit balance, patients may be enrolled if CT or MRI strongly suggest oncological lesion confirming the 18F- and/or 68Ga PET-CT PSMA positivity;
• total bilirubin ≤ 1.5 X institutional upper normal limit (this will not apply to patients with confirmed Gilbert's syndrome)
• haemoglobin ≥ 9 g/dL
• Patients must have measurable disease; patients with prostate cancer who have only bone lesions can be enrolled. See section 9.2 and Appendix D for the evaluation of measurable disease;
• Participation in another clinical trial with any investigational agents within 30 days prior to study treatment start. A window of 3 days is permitted;
• ECOG performance status ≤ 2 (see Appendix A);
• Patients will be admitted to therapeutic phase only if the diagnostic PET/CT PSMA SUV max is ≥ 3;
• Relapse or progression of disease on CT/MRI scan and/or WBD-MRI;
• AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper normal limit (\< 5 X UNL in presence of liver metastases)
• creatinine ≤ 2 mg/dL
• Patients who have completed chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) and hormonotherapy within 2 weeks (excluding mCRPC patients), prior to treatment start. A window of 3 days is permitted;
• Life expectancy of greater than 12 weeks;
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-PSMAs or other agents used in the study;
• For patients with prostate cancer: documented radiological progression (in soft tissue and / or bone) and/or biochemical progression (sequence of PSA rising values from a minimal starting value ≥ 1 ng/ml) according to PCWG3;
• No therapeutic alternatives;
• Patients must have normal organ and marrow function as defined below:
• leukocytes ≥ 3,000/μL
• All acute toxic effects of any prior therapy (including surgery, radiation therapy, and chemotherapy) must have resolved to a grade ≤ 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE);
• platelets ≥100,000/μL

Exclusion

Exclusion criteria not yet provided.