3
Indication details
- Control Arm
- Androgen receptor pathway inhibitor (ARPI/ARDT)
- Therapeutic Indication
- Lutetium Lu 177 vipivotide tetraxetan treatment for adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Prostate cancer
- Tumour Stage
- Advanced
- Tumour Sub-Group
- PSMA+ (mCRPC)
- Trial Name
- PSMAfore
- NCT Number
- NCT04689828
- Trial Phase
- Phase III
Primary Outcome(s)
- Primary Outcome(s)
- rPFS (primary-ITT), OS (secondary). Crossover allowed
- Evaluated Outcome
- rPFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 5.59 months
- PFS Gain
- 6.01 months
- PFS HR
- 0.49 (0.39 - 0.61)- Third data cut off
- OS Control
- 23.85 months
- OS Gain
- -0.19 months
- OS HR
- 0.98 (0.75 - 1.28) p=0.44, NS, immature
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 497
- Scorecard version
- 1
- Issue date
- 18.04.2025
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.