Key Points
- Prostate cancer is the most commonly diagnosed cancer in men, representing 19% of all newly reported cancer cases.
- It is responsible for 8% of all cancer deaths in men.
- Patients who have newly diagnosed radiographically evident metastatic disease, either as a de novo diagnosis of prostate cancer or as a manifestation of disease progression through earlier clinical disease states, are termed as having “metastatic non-castrate” prostate cancer.
- Historically, standard treatment for metastatic non-castrate disease has been androgen deprivation therapy (ADT) until progression, at which time patients are described as having metastatic castration-resistant prostate cancer (mCRPC), and then ADT is continued with additional treatments offered.
Treatment
ADT + Docetaxel
- For men with metastatic non-castrate prostate cancer with high volume disease per CHAARTED who are candidates for treatment with chemotherapy, the addition of docetaxel to ADT should be offered. (Strong Recommendation for high volume disease patients as per CHAARTED; EB-H )
- For patients with low volume disease per CHAARTED who are candidates for chemotherapy, docetaxel plus ADT may be offered. (Moderate Recommendation for low volume disease patients; EB-H)
- The appropriate regimen of docetaxel is six doses of docetaxel given every three weeks at 75 mg/m2 either alone (per CHAARTED) or with prednisolone (per STAMPEDE). (Strong Recommendation; EB-H)
ADT + Abiraterone
- For men with high-risk de novo metastatic non-castrate prostate cancer, the addition of abiraterone to ADT should be offered, per LATITUDE. (Strong Recommendation for high-risk disease patients as per LATITUDE; EB-H)
- For men with lower-risk de novo metastatic non-castrate prostate cancer abiraterone may be offered, per STAMPEDE. (Moderate Recommendation for lower-risk patients per STAMPEDE; EB-H)
- The appropriate regimen is abiraterone 1000 mg with either prednisolone or prednisone 5 mg once daily until treatment(s) for mCRPC are initiated. (Strong Recommendation; EB-H)
Key Recommendation
- Docetaxel and abiraterone are two separate standards of care for metastatic non-castrate prostate cancer. The use of both standards in combination or in series has not been assessed and therefore cannot be recommended. (Strong Recommendation; EB)
Qualifying Statements
- For subsets of men with newly diagnosed metastatic non-castrate disease, treatment with abiraterone or docetaxel in combination with ADT should be offered on the basis of prolonging life relative to ADT alone. For docetaxel, the data are most compelling for men with de novo high volume metastatic non-castrate prostate cancer (defined 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) who are chemotherapy candidates. The appropriate regimen of docetaxel is six doses of docetaxel given every three weeks at 75 mg/m2 either alone (per CHAARTED) or with prednisolone (per STAMPEDE). (Strong Recommendation; EB-H)
- Men with de novo metastatic non-castrate high-risk disease per LATITUDE (two or more of the factors of Gleason score ≥8, ≥3 bone metastases, and measurable visceral disease) who are fit for treatment with abiraterone should receive ADT and AAP. Lower risk men may also be offered ADT and AAP (per STAMPEDE). The appropriate regimen is abiraterone 1000 mg with either prednisolone or prednisone 5 mg once daily. (Strong Recommendation; EB-H)