4
Indication details
- Control Arm
- Placebo
- Treatment setting
- Castraction-refractory pre-docetaxel (early termination with crossover)
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Prostate cancer
- Tumour Stage
- Metastatic
- Trial Name
- PREVAIL
- NCT Number
- NCT01212991
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval September 2014
- EMA Approval
- EMA (CHMP) October 2014 EC decision December 2014
Primary Outcome(s)
- Primary Outcome(s)
- PFS and OS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 3.9 months
- PFS Gain
- >12 months
- PFS HR
- 0.19 (0.15-0.23)
- OS Control
- 30.2 months*
- OS Gain
- 2.2 months
- OS HR
- 0.71 (0.60-0.84)
Adjustments
- QoL Comment
-
QoL evaluated as an exploratory endpoint (as distinct from primary or secondary endpoint) is not eligible for ESMO-MCBS grading
Final Score (after adjustments)
- Preliminary non-curative score
-
3
- Early stopping or crossover
- 1+
- Final non-curative score
-
4
- Comment
-
*Form 2a cannot be applied since median OS was not reached in the control arm; consequently, the score was derived from Form 2b criteria with an upgrade for early stopping based on OS advantage detected at the interim analysis.
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 100
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 10.08.2023
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.