3
Indication details
- Control Arm
- Enzalutamide or abiraterone (crossover allowed)
- FDA Therapeutic Indication
- Treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Prostate cancer
- Tumour Stage
- Metastatic
- Tumour Sub-Group
- Patients with ≥1 alteration in BRCA1, BRCA2 or ATM
- Trial Name
- PROfound
- NCT Number
- NCT02987543
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval May 2020
- EMA Approval
- EMA (September 2020) EC decision November 2020
Primary Outcome(s)
- Primary Outcome(s)
- PFS (66% crossed over)
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 3.6 months
- PFS Gain
- 3.8 months
- PFS HR
- 0.34 (0.25-0.47)
- OS Control
- 14.7 months
- OS Gain
- 4.4 months
- OS HR
- 0.69 (0.50-0.97)*
Adjustments
- QoL Comment
-
No overall QoL benefit observed
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
- Comment
-
*P=0.02 meets the pre-specified threshold P=0.047 for the final OS analysis.
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 216
- Scorecard version
- 1
- Issue date
- 26.10.2020
- Last update
- 08.08.2023
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.