Recruiting

\[177Lu\]Lu-PSMA-617

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07697989

Conditions

Prostatic Neoplasms, Castration-Resistant

Neoplasm Metastasis

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07697989

Start date

Oct 1, 2026

Status verified date

Jul, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

1. 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.
2. 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.
3. Patients with an mCRPC diagnosis on or after the metastatic diagnosis or satisfying any of the proxy criteria.
4. 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.
5. Patients ≥18 years of age on metastatic diagnosis date.
6. Patients who are male.
7. 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).

Exclusion criteria:

1. 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.
2. 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).
3. Patients with missing age and gender information.

Study Design

Enrollment

1085 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Real-World Overall Survival (rwOS) [ Time Frame: Up to approximately 3 years ]
  • Median rwOS [ Time Frame: Up to approximately 3 years ]

Central Contacts and Locations

Central contacts

Locations

Novartis

Recruiting

East Hanover, New Jersey, United States, 07936

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Oct 30, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-10-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.