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NCT05219500 (Ac225-PSMA I&T in Metastatic Castration Resistant Prostate Cancer): BVCT ex-ante prediction vs. reported outcome

On 1 Dec 2023, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 9 Apr 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT05219500
Acronym
TATCIST
Drug Name
Ac225-PSMA I&T
Drug MoA
anti-PSMA mAb conjugated to alpha particle-emitting cytotoxic isotope Actinium-225
Drug Modality
radioligand therapy
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Human Patients
115
Sponsor
Fusion Pharmaceuticals
Phase
Phase 2

Prediction of , index 1137

Prospective Prediction
Prediction Index
1137
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient clinical benefit non-inferior and non-superior to SoC)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
130 days in advance
Readout Data Interpretation
50% PSA50 33% ORR (vs 57.6% PSA50 and 50.7% ORR of Pluvicto or 42% ORR PSA50 and 60% ORR of PNT2002 in advanced mCRPC).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
PSMA-directed Targeted Alpha Therapy With FPI-2265 (225Ac-PSMA-I&T) for the Treatment of Metastatic Castration-resISTant Prostate Cancer (TATCIST). A Phase II Clinical Trial.
Phase
Phase 2
Status
Active not recruiting
Enrollment
115
Lead sponsor
Fusion Pharmaceuticals Inc.
Conditions
Metastatic Castration Resistant Prostate Cancer
Interventions
DRUG: FPI-2265
Design
Single group · None
Primary purpose
Treatment
Start
2021-12-16
Primary completion
2025-05-30
Completion
2026-07-31
Primary outcomes
  • To evaluate the effect of FPI-2265 on prostate-specific antigen (PSA) in participants with mCRPC. (From start of treatment until 12 weeks after the first treatment.)

NCT05219500 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials