4
Indication details
- Combined Agent(s)
- ADT ((androgen deprivation therapy) + docetaxel
- Control Arm
- ADT + Docetaxel + placebo
- FDA Therapeutic Indication
- For adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Prostate cancer
- Tumour Stage
- Metastatic
- Trial Name
- ARASENS
- NCT Number
- NCT02799602
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval August 2022
- EMA Approval
- EMA (CHMP) January 2023 EC decision March 2023
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 48.9 months*
- OS Gain
- 23.0 months (Calculated estimate of gain based on PE HR 0.68)
- OS HR
- 0.68 (0.57-0.80)
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
- Comment
-
*OS of the control arm may be overestimated by inadequate post-progression treatment of control arm patients with abiraterone or enzalutamide when castrate resistant
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 352
- Scorecard version
- 1
- Issue date
- 22.09.2022
- Last update
- 10.02.2023
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.