A Study of Real-world Effectiveness of 177Lu-PSMA-617 With and Without Concurrent Androgen Receptor Pathway Inhibitors in Metastatic Castration Resistant Prostate Cancer Patients

Adult male patients with mCRPC treated with 177Lu-PSMA-617 with or without concurrent ARPI on/after March 23, 2022 who received prior and progressed on an ARPI therapy in the metastatic setting.

Inclusion criteria:

• Has an International Classification of Diseases (ICD) diagnosis of prostate cancer (ICD-9 185x; ICD-10 C61x)

• At least two documented clinic visits on different days in the database network occurring on or after January 1, 2011.

• Has evidence of prostate cancer with an initial or metastatic diagnosis date, as identified by a machine learning (ML) model from unstructured documents.

• Diagnosis of mCRPC

• Aged ≥18 years at mCRPC diagnosis.

• Histology of Adenocarcinoma or prostate cancer, not otherwise specified (NOS).

• Evidence of pre-index exposure to an ARPI (abiraterone acetate, enzalutamide, darolutamide, or apalutamide) in the metastatic setting

• Evidence of ARPI progression on the ARPI line of treatment (LOT) immediately preceding 177Lu-PSMA-617 initiation, defined as

  • evidence of a progression date (per the database's real-world progression-free survival (rwPFS) variables), during or after the preceding ARPI LOT
  • a castration-resistant prostate cancer (CRPC) date occurring during or after the preceding ARPI LOT

• Evidence of initiating a 177Lu-PSMA-617-containing LOT with or without a second-generation ARPI (abiraterone acetate, enzalutamide, darolutamide, or apalutamide) in mCRPC setting between 23 March 2022 and 31 October 2025, with concurrent therapies limited to androgen deprivation therapy (ADT) and/or 1st-generation antiandrogens only, and no other concurrent therapies permitted.

• At least 6 months of potential minimum follow-up from the first 177Lu-PSMA-617-containing LOT

• Patients may not receive a clinical study drug (CSD) any time prior to 177Lu-PSMA-617-containing LOT.

Exclusion criteria:

Applied to ARPI-experienced mCRPC patient cohort:

Individuals will be excluded if they meet any of the following criteria:

• Evidence of unknown histology.
• Patients enrolled in clinical trials at the time of 177Lu-PSMA-617 initiation.