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

NCT07843758 | Completed

• 1 other identifier: CAAA617A12004
• Study Type: observational
• Target: 1,525
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the effectiveness of 177Lu-PSMA-617 (lutetium (177Lu) vipivotide tetraxetan) on survival in patients randomized to receive treatment following progression on one ARPI from the PSMAfore trial compared to the effectiveness of a change in ARPI treatment on survival in a real-world setting in patients with mCRPC who are taxane-naive but have progressed after a switch in ARPI.

Conditions

Castration-Resistant Prostatic Cancer

Keywords

Metastatic Castration-Resistant Prostate Cancer; External control arm; Real world data

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS) of the TTA Group

  OS defined as time from randomization to death due to any cause.

  Up to approximately 3 years and 6 months

• Real-world Overall Survival (rwOS) of the ECA Group (for the Primary Measure)

  rwOS is defined as the time from initiation of the index ARPI to death due to any cause.

  Up to approximately 7 years

Secondary Outcomes (2)

• OS of the TCA Group

  Up to approximately 3 years and 6 months

• rwOS of the ECA Group (for the Secondary Measure)

  Up to approximately 7 years

Study Arms (3)

External Control Arm (ECA)

RWD patients with mCRPC who were treated with a change in ARPI after progression on prior ARPI and before taxane treatment.

PSMAfore Trial Treatment Arm (TTA)

PSMAfore trial patients with mCRPC who were treated with 177Lu-PSMA-617 after progression on one ARPI.

PSMAfore Trial Control Arm (TCA)

PSMAfore trial patients with mCRPC who switched to a subsequent ARPI after progression on a prior ARPI.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PSMAfore trial patients with mCRPC who progressed once after treatment with an ARPI and were taxane-naive, and real-world data (RWD) mCRPC patients from the United States (US)-based health research database who were taxane-naive and had evidence of treatment with a change in ARPI immediately following progression.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Female sex.
• Had evidence of untreated brain metastases.
• 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).
• Evidence of biomarker status that would indicate eligibility for treatment other than ARPI, or better prognosis.
• 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).
• Had evidence of inadequate organ function.
• Had evidence of low levels of albumin (\< 2.5 g/dL).
• Had evidence of a negative PSMA-PET scan.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

Basel, CH-4056, Switzerland

Location

Related Links

• Link to study results

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant

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

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 28, 2026
• Study Start: March 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)