Pluvicto Real-world Investigation in Survival in Metastatic CRPC

NCT07697989 | Not Yet Recruiting

• 1 other identifier: CAAA617A12008
• Study Type: observational
• Target: 1,085
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the various aspects of treatment effectiveness of \[177Lu\]Lu-PSMA-617 (Pluvicto) in mCRPC patients in both pre- and post-taxane settings. The study will be conducted using real-world data sources from the United States (US) and Germany.

Conditions

Prostatic Neoplasms, Castration-Resistant; Neoplasm Metastasis

Keywords

Pluvicto; 177Lu-PSMA-617; Metastatic Castration Resistant Prostate Cancer; Effectiveness; Survival

Outcome Measures

Primary Outcomes (2)

• Real-World Overall Survival (rwOS)

  rwOS, defined as the time from index date, i.e., date of \[177Lu\]Lu-PSMA-617 administration, until death due to any cause.

  Up to approximately 3 years

• Median rwOS

  Median rwOS, defined as the time from the index date, i.e., date of \[177Lu\]Lu-PSMA-617 administration, to when half of the patients in the cohort are still alive.

  Up to approximately 3 years

Secondary Outcomes (26)

• Baseline Demographics

  Baseline

• Proportion of Patients by Clinical Characteristic

  Baseline

• Proportion of Patients by Clinical Characteristic: Eastern Cooperative Oncology Group (ECOG) Performance Status

  Baseline

• Proportion of Patients by Clinical Characteristic: Karnofsky Performance Status

  Baseline

• Duration Between Metastatic PC Diagnosis and mCRPC Diagnosis

  Baseline

Study Arms (3)

Overall mCRPC Cohort

Adult male mCRPC patients who have received at least one dose of \[177Lu\]Lu-PSMA-617.

Chemo-naive mCRPC Cohort

A sub-group of the Overall mCRPC Cohort. Adult male mCRPC patients who have received at least one dose of \[177Lu\]Lu-PSMA-617 and have not received chemotherapy in the mCRPC stage.

Post-taxane mCRPC Cohort

A sub-group of the Overall mCRPC Cohort. Adult male mCRPC patients who have received at least one dose of \[177Lu\]Lu-PSMA-617 after taxane-based chemotherapy in the mCRPC stage.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male patients with mCRPC in the US and Germany, who received \[177Lu\]Lu-PSMA-617.

You may qualify if:

• Patients with at least one inpatient OR two outpatient primary prostate cancer (PC) diagnosis (International Classification of Diseases, Tenth Revision, Clinical Modification \[ICD-10-CM\]: C61) during the identification period. For outpatient diagnoses, the second confirmatory PC diagnosis must be at least 30 to 365 days after the first primary diagnosis date.
• Patients with a metastatic diagnosis (ICD-10-CM: C77-C79) on or after the primary PC diagnosis date. The earliest metastatic diagnosis will be the patient's metastatic diagnosis date.
• Patients with an mCRPC diagnosis on or after the metastatic diagnosis or satisfying any of the proxy criteria.
• Patients with evidence of treatment with \[177Lu\]Lu-PSMA-617 after the mCRPC diagnosis date. The date of \[177Lu\]Lu-PSMA-617 administration will be considered as the index date.
• Patients ≥18 years of age on metastatic diagnosis date.
• Patients who are male.
• Patients with at least 12 months pre-index and at least six months post-index (unless patient died) of medical history or continuous medical and pharmacy enrollment or activity (three-month allowable gap).

You may not qualify if:

• Patients with other non-prostate primary cancer (≥ two ICD codes for one specific type of cancer in the baseline period at least 30 days apart) within three years prior to the first PC diagnosis.
• Patients enrolled in a current clinical trial/investigational study within the 30-day period immediately prior to and including the index date or within five half-lives of the investigational product (whichever is longer) or during post-index period (ICD-10-CM: Z00.6).
• Patients with missing age and gender information.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share