2
Indication details
- Combined Agent(s)
- Abiraterone and prednisone or prednisolone
- Control Arm
- Placebo + abiraterone and prednisone or prednisolone
- Treatment setting
- In combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration resistant prostate cancer in whom chemotherapy is not clinically indicated
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Prostate cancer
- Tumour Stage
- Metastatic
- Trial Name
- PROpel
- NCT Number
- NCT03732820
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) November 2022 EC decision February 2023
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 16.6 months
- PFS Gain
- 8.2 months
- PFS HR
- 0.66 (0.54-0.81)
Adjustments
- QoL Comment
-
Exploratory QoL evaluation: No improvement
- Toxicity Comment
-
6.5% vs 1.8% pulmonary embolism
Final Score (after adjustments)
- Preliminary non-curative score
-
3
- Toxicity adjustment
- 1-
- Final non-curative score
-
2
- Comment
-
EMA (CHMP) November 2022 EC decision February 2023
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 365
- Scorecard version
- 1
- Issue date
- 05.12.2022
- Last update
- 11.02.2023
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.