Brief Summary
The aim of this study is to determine the maximum safe and effective dosethe amount of medication taken of a novel therapeutic ADVC001 complexed with the radio-isotope alpha-212 ([212Pb]Pb-ADVC001) for the treatment of metastatic prostatea walnut-shaped gland in the male reproductive system that is responsible for producing semen - a bodily fluid that acts as a vessel for sperm transport during ejaculation cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs.
Intervention/Treatment
- Drug: [212Pb]Pb-ADVC001
Inclusion Criteria
- Male aged 18 years or older with metastatic adenocarcinomacancer arising from mucus-producing glands in organs of the prostate, defined by documented histopathology of prostate adenocarcinoma or metastatic disease typical of prostate cancer (i.e. Involving bone or pelvic lymph nodessmall bean-shaped structures that filters harmful substances from lymph fluid or para-aortic lymph nodes).
- Patients with castration-resistant prostate cancer that have received at least one cycle of androgen receptor therapy and exposure to a taxane-based chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells unless considered contraindicated by a medical oncologista doctor who specialises in the study, diagnosis and treatment of cancer or patient declines treatment.
- Progressive disease with rising PSA level, or new lesion(s) in the viscera or lymph nodes as per RECIST 1.1 or in bone as per Prostate Cancer Working Group 3.
- Significant PSMA avidity on [68Ga]Ga-PSMA PET/CT.
- ECOG Performance status 0 to 2.
- Adequate renal, bone and liver function (Absolute neutrophil count: greater than or equal to 2 x 109 /L , Hemoglobin: greater than or equal to 90 g/L, Platelet count: greater than or equal to 150,000 x 109/L, Serum creatinine: less than 1.5 x upper limit of normal (ULN) i.e = 125 umol/L or calculated creatinine clearance greater than or equal to 60 mL/min/1.73 m2 by Cockcroft-Gault formula, Serum total bilirubin: less than 1.5 x ULN (unless the patient has Gilbert’s syndrome in which case direct bilirubin must be normal), Serum AST and ALT: less than 1.5 x ULN in the absence of liver metastases; less than 3 x ULN if due to liver metastases (in both circumstances bilirubin must meet entry criteria).
- Estimated life expectancy greater than 12 weeks.
- Willing and able to comply with all study requirements, including the timing and nature of all required assessments (i.e. bloodthe red bodily fluid that transports oxygen and other nutrients around the body testing and scanning.).
- Have provided written Informed Consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. for participation in this trial.