4
Indication details
- Combined Agent(s)
- Prednisone + ADT (androgen deprivation therapy)
- Control Arm
- ADT + placebo
- FDA Therapeutic Indication
- Indicated with prednisone or prednisolone for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Prostate cancer
- Tumour Stage
- High Risk
- Trial Name
- LATITUDE
- NCT Number
- NCT01715285
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval February 2018
- EMA Approval
- EMA (CHMP) October 2017 EC decision December 2017
Primary Outcome(s)
- Primary Outcome(s)
- OS and PFS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 14.8 months
- PFS Gain
- 18.2 months
- PFS HR
- 0.47 (0.39-0.55)
- OS Control
- 36.5 months*
- OS Gain
- 16.8 months
- OS HR
- 0.66 (0.56-0.78)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
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 castration-resistant
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 175
- Scorecard version
- 1
- Issue date
- 10.06.2020
- Last update
- 10.08.2023
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.