# SPLASH

Source: https://onco.cc/trials/splash/  
OnCo record `splash` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In SPLASH, a second PSMA radioligand improved progression-free survival but not, so far, survival.

## Summary

SPLASH, trial NCT04647526 sponsored by Lantheus through POINT Biopharma and reported in 2024, tested a second PSMA radioligand, 177Lu-PNT2002, also known as 177Lu-PSMA-I&T, against a switch of androgen receptor pathway inhibitor in PSMA-positive, taxane-naive metastatic castration-resistant prostate cancer. It randomised 412 men and met its primary radiographic progression-free survival endpoint, but the interim overall survival analysis was numerically unfavourable, with 46 percent of events and 84 percent crossover, and Lantheus deprioritised a US filing pending mature data. OnCo links it to prostate cancer and to the 177Lu-PSMA-I&T drug record; its effect was smaller than PSMAfore's with a different ligand and dosing, while ECLIPSE with the same ligand met its progression endpoint. Whether crossover masked a real benefit or the drug simply adds little is the open question.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-06
- Registry id: NCT04647526
- Phase: 3
- Setting: PSMA-positive mCRPC after one ARPI, taxane-naive: 177Lu-PNT2002 vs ARPI switch
- Sponsor: Lantheus (POINT Biopharma)
- Enrolled: 455
- Result: rPFS HR 0.71; interim OS HR 1.11.
- Outcomes: Radiographic progression-free survival: 177Lu-PNT2002 (PSMA-I&T) 9.5 months vs ARPI switch 6 months, HR 0.71; Overall survival (interim): 177Lu-PNT2002 vs ARPI switch, HR 1.11
- Replication: Smaller effect than PSMAfore (rPFS HR 0.41) with a different ligand and dosing; ECLIPSE (177Lu-PSMA-I&T) met rPFS.

## Sources

- ClinicalTrials.gov NCT04647526: https://clinicaltrials.gov/study/NCT04647526

## Connected records

- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Radioligand therapy (beta emitters)](https://onco.cc/technologies/radioligand-therapy/)
- drugs: [177Lu-PSMA-I&T](https://onco.cc/drugs/lu177-psma-it/)
- companies: [Lantheus](https://onco.cc/companies/lantheus/)
- key papers: [Initial clinical experience with [ 177 Lu]Lu-PNT2002 radioligand therapy in metastatic castration-resistant prostate cancer: dosimetry, safety, and efficacy from the lead-in cohort of the SPLASH trial](https://onco.cc/key-papers/paper-splash-front-oncol-2024/)

---
JSON: https://onco.cc/api/v1/entities/splash.json