{"analyses":[{"ciNumSides":"TWO_SIDED","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.05","statisticalMethod":"Wilcoxon (Mann-Whitney)","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.46","upperLimit":"4.58","value":"3.8"},{"groupId":"OG001","lowerLimit":"2.55","upperLimit":"51.93","value":"29.35"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"description":"Magnetic resonance imaging (MRI) of the sella and prolactin will be performed before (baseline) and after 6 months of treatment with cabergoline or pasireotide. Disease progression will be defined as tumor growth \\> 25%, stable disease as changes \\< 25% and significant tumor shrinkage as \\> 25% in tumor volume compared to baseline MRI (baseline to six months).","dispersionType":"Full Range","groups":[{"description":"For non-cured patients with resistant prolactinomas, MRI will be performed immediately before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month.\n\nFor patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated by MRI six months after pasireotide.\n\nPasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months.\n\nThe patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months.","id":"OG000","title":"Pasireotide"},{"description":"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.\n\ncabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.\n\nThe patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months.","id":"OG001","title":"Cabergoline"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"Baseline to six months","title":"Tumor Volume Changes for NFPA and Prolactin Level Changes for Prolactinoma","type":"PRIMARY","unitOfMeasure":"cmˆ3"}