3
Indication details
- Combined Agent(s)
- ADT (androgen deprivation therapy)
- Control Arm
- ADT + placebo
- Therapeutic Indication
- Non-metastatic castration resistant prostate cancer for adult men who are at high risk of developing metastatic disease
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Prostate cancer
- Tumour Stage
- Non-metastatic
- Trial Name
- ARAMIS
- NCT Number
- NCT02200614
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval December 2019
- EMA Approval
- EMA (January 2020) approval April 2020
Primary Outcome(s)
- Primary Outcome(s)
- MFS
- Evaluated Outcome
- MFS*
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 18.4 months
- PFS Gain
- 22.0 months
- PFS HR
- 0.41 (0.34-0.50)
- OS Control
- 3-year: 77%
- OS Gain
- 6% at 3 years
- OS HR
- 0.69 (0.53-0.88)
Adjustments
- QoL Comment
-
QoL was not a prespecified secondary endpoint
Final Score (after adjustments)
- Preliminary non-curative score
-
3
- Final non-curative score
-
3
- Comment
-
*Scoring of MFS on the same basis as PFS
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 183
- Scorecard version
- 1
- Issue date
- 01.07.2020
- 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.