An External Control Arm Study Comparing Survival Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With 177Lu-PSMA-617 vs Androgen Receptor Pathway Inhibitor (ARPI) Switch in Routine Care

Korábbi kezelés

• Evidence of prior treatment with therapies that potentially affect study outcomes (e.g., radiopharmaceuticals, taxane, immunotherapy or biological therapy, clinical study drug (CSD), or 177Lu-PSMA-617).

Más betegség

• Had history of cardiac comorbidities, infection with hepatitis B or C, or spinal cord compression that would indicate significant risk to PSMAfore trial participation.
• Diagnosis of an active additional malignancy (i.e., other than prostate cancer).

Laborértékek

• Had evidence of low levels of albumin (< 2.5 g/dL).

Egyéb

• Female sex.
• Had evidence of untreated brain metastases.
• Evidence of biomarker status that would indicate eligibility for treatment other than ARPI, or better prognosis.
• Had evidence of inadequate organ function.
• Had evidence of a negative PSMA-PET scan.
  • Other protocol-defined inclusion/exclusion criteria may apply.

• Had an International Classification of Diseases, 9th or 10th Revision, Clinical Modification (ICD-9-CM or ICD-10-CM) diagnosis of prostate cancer (PC) (ICD-9-CM 185x or ICD-10-CM C61x).
• Had at least two documented clinical visits, on different days, occurring on or after 01 Jan 2013.
• Included in probabilistic sample of patients queued for review via abstraction.
• Had diagnosis of metastatic disease on or after 01 Jan 2013.
• Histology was confirmed as adenocarcinoma of the prostate.
• Had confirmed mCRPC diagnosis.
• Treated with an ARPI-containing line of therapy (LOT; i.e., index therapy) in the mCRPC setting immediately after progression on one previous ARPI-containing line (in any setting, Hormone Sensitive PC or castration-resistant PC), as defined per the health research database's LOT rules and confirmed via abstraction.
• 18 years of age or older at the start of index therapy.
• Had an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0-1 within 30 days before or up to 7 days after index date, or unknown ECOG PS.