2
Indication details
- Combined Agent(s)
- Prednisone
- Control Arm
- Placebo–prednisone
- FDA Therapeutic Indication
- Treatment of mCRPC in adult men who are asymptomatic or mildly symptomatic after failure of ADT in whom ChT is not yet clinically indicated
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Prostate cancer
- Tumour Stage
- Metastatic
- Trial Name
- COU-AA-302
- NCT Number
- NCT00887198
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval December 2012
- EMA Approval
- EMA (CHMP) approved November 2012. EC decision January 2013.
- Comment
- EMA not approved in ChT-naïve patients
Primary Outcome(s)
- Primary Outcome(s)
- rPFS and OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 30.3 months
- OS Gain
- 4.4 months
- OS HR
- 0.81 (0.70-0.93)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
2
- Non-curative score
-
2
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 388
- Scorecard version
- 1
- Issue date
- 07.08.2023
- Last update
- 15.11.2024
Legend
Information about symbols, abbrevations and color codes
- 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
Red = negative / deterioration
Green = positive / improvement
Red = negative / deterioration
Green = positive / improvement
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include: