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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - Not specified

Sex eligible

Male

Healthy volunteers

Not accepted

Participants

2045 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This study aims to assess real-world clinical outcomes among adult metastatic castration-resistant prostate cancer (mCRPC) patients previously treated with and progressed on an androgen receptor pathway inhibitor (ARPI) who received 177Lu-PSMA-617 as a monotherapy or with concurrent ARPI. The study will use secondary data taken from a United States oncology database.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Study population

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (0)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

No locations are listed. Use the official study contact.

Study team and timeline

Lead sponsor

Novartis Pharmaceuticals

Study start

Nov 5, 2026 Estimated

Primary completion

Nov 25, 2026 Estimated

Study completion

Nov 25, 2026 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts