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Chemotherapy-Naïve Castration-Resistant Prostate Cancer Second-Line Hormonal Therapy

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Treatment Patient is being considered for Second-line Hormonal Therapies Algorithm for Second-line Hormonal CRPC Treatment (cont'd) High Risk for Developing Metastases • For chemotherapy-naïve patients at high risk of developing metastases (rapid PSA doubling time or velocity), second-line hormonal therapies which lower PSA values or slow the rate of rise may be offered, preferably in a clinical trial setting where available, following a discussion with the patient about the limited scientific evidence, potential harms, benefits, cost, and patient preferences. • Alternative treatment options include observation (with maintenance of a castrate state) or participation in a clinical trial. • Chemotherapy or immunotherapy is NOT recommended except in a clinical trial. • No evidence provides guidance about the optimal order of second-line hormonal therapies for patients with M0 CRPC. The panel was unable to come to consensus on sequencing. Following a discussion about the limited evidence, potential harms, benefits, cost and patient preferences with chemotherapy-naïve men after first-line treatment failure: • Abiraterone acetate plus prednisone or enzalutamide should be offered for second-line hormonal treatment following first-line hormonal treatment failure for chemotherapy- naïve men who develop CRPC and have radiographic evidence of metastases (M1a/ M1s CRPC) because these agents have been shown to significantly increase rPFS and OS. (Evidence-based, Strong recommendation) • Alternative treatment options include immunotherapy (sipuleucel-T) or chemotherapy (docetaxel and prednisone) or radium-223. • If none of the above therapies can be obtained or tolerated by the patient, other antiandrogens, prednisone and letoconazole/hydrocortisone may also be offered beause they provide modest clinical benefits in this population, but no survival benefits have been established. • Alternative treatment options include enrollment in a clinical trial and observation. • No evidence provides guidance about the optimal order of second-line hormonal therapies for patients with M1 CRPsC. • Other second-line hormonal therapy options where results from Phase III trials are pending should NOT be used. • A PSA evaluation every 3 months is recommended for men who develop CRPC with a rapid PSA doubling time, velocity or radiographic evidence of metastases (M1 CRPC). • Palliative care should be offered to all chemotherapy-naïve men with M1 CRPC, particularly those exhibiting symptoms of decreased quality of life. Radiographic evidence of metastases (M1a/M1s CRPC) No radiographic evidence of metastases (M0 CRPC)

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