4
Indication details
- Combined Agent(s)
- ADT (androgen deprivation therapy)
- Control Arm
- ADT + placebo
- FDA Therapeutic Indication
- In adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Prostate cancer
- Tumour Stage
- Metastatic
- Trial Name
- TITAN
- NCT Number
- NCT02489318
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval September 2019
- EMA Approval
- EMA (CHMP) December 2019 EC decision February 2020
Primary Outcome(s)
- Primary Outcome(s)
- PFS/OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 22.1 months
- PFS Gain
- 23.0 months (Calculated estimate of gain based on PE HR 0.48)
- PFS HR
- 0.48 (0.39-0.60)
- OS Control
- 52.2 months*
- OS Gain
- 28.1 months (Calculated estimate of gain based on PE HR 0.65)
- OS HR
- 0.65 (0.53-0.79)
Adjustments
- QoL Comment
-
No benefit
- Toxicity Comment
-
Ischemic heart disease 4.4% versus 1.5%
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
- 184
- 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.