Recommendation 1.95
➤ The recommended regimen for men with metastatic noncastrate
prostate cancer is apalutamide (240 mg per day) with ADT (Strong
recommendation; EB-B-H).
Qualifying Statements for ADT Plus Apalutamide
• Men with metastatic noncastrate prostate cancer previously treated with docetaxel
appear to benefit with respect to radiographic progression-free survival, but the
answer is not yet conclusive. At 22.7 months, ADT plus apalutamide was associated
with significantly longer radiographic progression-free survival (rPFS) and OS
compared to ADT plus placebo. The effect of ADT plus apalutamide on rPFS was
consistently favorable and statistically significant for most subgroups, including
disease volume, Gleason score and metastasis stage (M0/M1) at initial diagnosis,
but not previous docetaxel use (favored ADT plus apalutamide but was not
statistically significant). It is anticipated that the long-term results will confirm the
early findings. Median OS among men previously treated with docetaxel could not
yet be estimated. Longer follow-up is needed. Apalutamide was FDA approved for
use in the metastatic noncastrate prostate cancer population as of September 17,
2019. Discussions with patients should include the lack of long-term benefit data
for men previously treated with docetaxel and the cost of apalutamide treatment.
Combination Therapies
Recommendation 2.1
➤ ADT plus abiraterone and prednisolone should be considered for men
with noncastrate locally advanced non-metastatic prostate cancer,
rather than castration monotherapy, due to the failure-free survival
benefit per STAMPEDE. Radiotherapy to the primary was mandated in
STAMPEDE for patients with newly diagnosed node-negative, non-
metastatic disease and encouraged in patients with newly diagnosed
node-positive, non-metastatic disease. Failure-free survival (time to
the earliest of biochemical failure, disease progression, or death), was
significantly improved for patients with non-metastatic disease treated
with ADT plus abiraterone and prednisolone compared to those treated
with ADT alone, even though ADT plus abiraterone was administered
for two or less years to men with non-metastatic disease (Strong
recommendation; EB-B-H).
