BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04720157 (177Lu-PSMA-617 in 1L PSMA-positive metastatic hormone-sensitive prostate cancer): BVCT ex-ante prediction vs. reported outcome

On 2 Jul 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 2 Jun 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (PFS) and commercially insufficient (non-superior OS).

Clinical Trial

NCTID
NCT04720157
Acronym
PSMAddition
Drug Name
177Lu-PSMA-617
Drug MoA
anti-PSMA radionuclide drug conjugates
Drug Modality
radionuclide drug conjugate
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
1L PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC)
Human Patients
1145
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3

Prediction of , index 1650

Prospective Prediction
Prediction Index
1650
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in OS)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit in rPFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
335 days in advance
Readout Data Interpretation
pluvicto + SoC achieved statistically significant clinical benefit in PFS compared with SoC alone; yet failed to achieve statistically significant clinical benefit in OS compared with SoC alone
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (PFS) and commercially insufficient (non-superior OS)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
An Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care, Versus Standard of Care Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
Phase
Phase 3
Status
Active not recruiting
Enrollment
1140
Lead sponsor
Novartis Pharmaceuticals
Conditions
Prostatic Neoplasms
Interventions
DRUG: 177Lu-PSMA-617; DRUG: 68Ga-PSMA-11; DRUG: ARDT; DRUG: ADT
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2021-06-09
Primary completion
2025-01-13
Completion
2027-02-11
Primary outcomes
  • Radiographic Progression Free Survival (rPFS) (From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 50 months (estimated final OS analysis))

NCT04720157 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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