A Study to Assess How Radium-223 Distributes in the Body of Patients With Prostate Cancer Which Spread to the Bones

This is an interventional treatment trial for Bone Metastatic Castration-resistant Prostate Cancer focused on measuring Metastatic castration-resistant prostate cancer (mCRPC), Single-photon emission tomography / computed tomography (SPECT/CT), radium-223,, phase I Read More

Inclusion Criteria:

• Participants who have histologically confirmed adenocarcinoma of the prostate.
• Participants with bone metastatic CRPC, progressing after 1 or 2 prior lines of systemic treatment for metastatic prostate cancer (including prior treatment for metastatic hormone sensitive prostate mHSPC or metastatic castration resistant prostate cancer mCRPC).
• Participants with at least 2 bone metastases on Tc 99m phosphonate whole body planar bone scans at Screening.
• Documented progression of mCRPC. Disease progression is defined by at least one of the following criteria: a. PCWG3 criteria (defined as 2 consecutive increases in PSA over a previous reference value measured at least one week prior, with a minimal start value of 1.0 ng/mL) or b. ≥2 new bone lesions (according to PCWG3 bone scan criteria) or c. Radiological progression according to RECIST, version 1.1.
• Ability to participate in the required study procedures including all scanning procedures and ability to control pain to ensure tolerance and completion of the necessary scanning procedures.
• Maintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7 nmol/L). If the participant is being treated with luteinizing hormone releasing hormone (LHRH) agonists or antagonists (participant who has not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to start of Screening and must be continued throughout the study.
• Participants must be on a bone health agent prior to the first dose of radium-223 dichloride. Participants with at least 6 months of prior bone health agent (BHA) treatment are preferred.
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
• Life expectancy ≥6 months.

Exclusion Criteria:

• Any chronic medical condition requiring continuous systemic corticosteroid treatment at a higher dose than 5 mg prednisone / prednisolone twice daily.
• Pathological finding consistent with neuroendocrine features small cell carcinoma of the prostate.
• Metastatic bone deposits extend of disease (EOD) grades 0 or 4 (according to centrally assessed Tc 99m phosphonate planar bone scans during Screening).
• History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations (according to central review at screening).
• Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer).
• Imminent spinal cord compression based on clinical findings and / or magnetic resonance imaging (MRI). - Participants with history of spinal cord compression should have completely recovered.
• Active or symptomatic viral hepatitis
• Inability to tolerate any of the other imaging procedures in the study (ie, bone SPECT/CT and planar bone scans with a Tc 99m phosphonate radiotracer, DXA scan, radium-223 SPECT/CT scans).
• Any condition, which in the opinion of the investigator would preclude participation in this trial.
• Hypersensitivity to radium-223 dichloride.
• Blood transfusion or erythropoietin stimulating agents 4 weeks prior to start of Screening and during the whole Screening period before enrollment into the cohort.
• Prior administration of an investigational therapeutic for CRPC.