Clinical trial · Observational
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
Comparing the Lutetium (177Lu) Vipivotide Tetraxetan Arm of the PSMAfore Clinical Trial to a Switch in Androgen Receptor Pathway Inhibitor (ARPI) as External Control Arm (ECA) Using a Real-world Data Source for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) After Progression on Prior ARPI
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-Resistant Prostatic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- External Control Arm (ECA)
- description
- RWD patients with mCRPC who were treated with a change in ARPI after progression on prior ARPI and before taxane treatment.
- label
- PSMAfore Trial Treatment Arm (TTA)
- description
- PSMAfore trial patients with mCRPC who were treated with 177Lu-PSMA-617 after progression on one ARPI.
- label
- PSMAfore Trial Control Arm (TCA)
- description
- PSMAfore trial patients with mCRPC who switched to a subsequent ARPI after progression on a prior ARPI.
Primary outcomes (2)
- measure
- Overall Survival (OS) of the TTA Group
- timeFrame
- Up to approximately 3 years and 6 months
- description
- OS defined as time from randomization to death due to any cause.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion criteria: 1. 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). 2. Had at least two documented clinical visits, on different days, occurring on or after 01 Jan 2013. 3. Included in probabilistic sample of patients queued for review via abstraction. 4. Had diagnosis of metastatic disease on or after 01 Jan 2013. 5. Histology was confirmed as adenocarcinoma of the prostate. 6. Had confirmed mCRPC diagnosis. 7. 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. 8. 18 years of age or older at the start of index therapy. 9. 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. Exclusion criteria: 1. Female sex. 2. Had evidence of untreated brain metastases. 3. Had history of cardiac comorbidities, infection with hepatitis B or C, or spinal cord compression that would indicate significant risk to PSMAfore trial participation. 4. Diagnosis of an active additional malignancy (i.e., other than prostate cancer). 5. Evidence of biomarker status that would indicate eligibility for treatment other than ARPI, or better prognosis. 6. 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). 7. Had evidence of inadequate organ function. 8. Had evidence of low levels of albumin (\< 2.5 g/dL). 9. Had evidence of a negative PSMA-PET scan. Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available