Clinical Trial Radar

Prior treatment with radioligand therapy including other lutetium-labeled compounds.

Prior treatment with radium-223 (Xofigo) within the past 12 weeks.

Prior chemotherapy treatment for castration-resistant prostate cancer. Prior docetaxel use in the hormone-sensitive setting is permitted, as long as no more than 6 doses were received, the last dose was administered >1 year prior to consent, and disease progression did not occur during docetaxel treatment.

Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2

Patients with known HRR gene-mutation (BRCA 1/2 encompassing both germline and somatic) who have not been previously treated with olaparib or rucaparib.

Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.

Inadequate organ and bone marrow function as evidenced by:

1. Hemoglobin < 8 g/dL.
2. Absolute neutrophil count < 1.5 x 109/L.
3. Platelet count < 100 x 109/L.
4. AST/SGOT and/or ALT/SGPT > 3.0 x ULN.
5. Total bilirubin > 2 x ULN unless patient has known Gilbert's syndrome and then may be 3 x ULN.
6. Creatinine clearance (CrCl) < 50 mL/min based on the Cockcroft-Gault equation.
7. Albumin ≤ 2.75 g/dL

Patients who undergo a transfusion for the sole purpose of meeting eligibility for this trial will be excluded.

Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.

Use of an investigational therapeutic drug within the last 4 weeks prior to start of study treatment or scheduled to receive one during the study period.

Known CNS metastasis unless received therapy, asymptomatic and neurologically stable.

Patients receiving zoledronic acid for bone-targeted therapy must be on stable dose for 4 weeks prior to randomization.

Major surgery within 30 days of randomization as determined by the Investigator.

Patients with active significant cardiac disease defined by any of the following:

1. New York Heart Association class 3 or 4 congestive heart failure within 6 months of signing the ICF unless treated with improvement.
2. Current diagnosis of electrocardiogram abnormalities with significant cardiac arrhythmias
3. History of long QT syndrome or know history of Torsades de Pointe
4. History of myocardial infarction, angina pectoris, or coronary artery bypass graft within 6 months of ICF signature

Participants with symptomatic cord compression or clinical/radiological findings indicating impending spinal cord compression

Patients with a superscan seen on baseline bone scan as determined by investigator.

Active malignancy other than low-grade non-muscle-invasive bladder cancer and non-melanoma skin cancer

Previous use of G-CSF for persistent neutropenia after standard of care treatment.

Participants who have a pregnant partner or are capable of fathering a child and who are unwilling to take precautions to prevent potential harm to the fetus or prevent pregnancy.

Participants with active Covid19. Recovered patients may be included when completely recovered (no symptoms at least 28 days before study medication and a negative Covid test within 72 hours).