Treatment
Qualifying Statements for ADT Plus Docetaxel
• The strongest evidence of benefit for docetaxel is for those men who were diagnosed
with de novo metastatic disease or HVD (defined per CHAARTED as four or more
bone metastases, one or more of which is outside of the spine or pelvis, and/or the
presence of any visceral disease). The criteria apply independent of the presence or
absence of nodal disease.
• Men with metastatic disease who do not fit into these categories should not be
offered docetaxel. The strength of the evidence to support an overall survival (OS)
benefit is not compelling for men who do not have de novo metastatic disease and/
or who do not meet the HVD criteria. Long term survival data from CHAARTED
and a post hoc aggregated analysis of CHAARTED and GETUG-AFU-15 data only
showed an OS benefit for men with HVD and de novo metastases. There was no OS
benefit for LVD, irrespective of whether the patients had metastases at diagnosis or
after failure of prior local therapy. Clarke, et al., reexamined OS by disease burden
using STAMPEDE data with longer follow-up, but the study was inadequately
powered (<80%) to detect an OS difference by disease burden if in fact one existed.
• As a chemotherapy agent, docetaxel is associated with somewhat greater toxicity than
androgen-targeted therapies such as abiraterone, but the treatment course is relatively
short, and the costs associated with treatment are generally covered by insurance,
hence reducing the financial burden to the patient.
ADT Plus Abiraterone
Recommendation 1.4
➤ For men with high-risk de novo metastatic noncastrate prostate cancer,
the addition of abiraterone to ADT should be offered per LATITUDE
(Strong recommendation [for patients with high-risk disease as defined
per LATITUDE]; EB-B-H).
Recommendation 1.5
➤ For men with low-risk de novo metastatic noncastrate prostate cancer,
ADT plus abiraterone may be offered per STAMPEDE (Moderate
recommendation; EB-B-H [for patients with low-risk disease per
STAMPEDE]).
Recommendation 1.6
➤ The recommended regimen for men with metastatic noncastrate prostate
cancer is abiraterone 1,000 mg with either prednisolone or prednisone
5 mg once daily until progressive disease is documented (Strong
recommendation; EB-B-H).
