2024-516383-28-01招募中3 期
Surgical versus Medical Treatment in Microprolactinomas (SUMET PRO)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Prolactin levels will be measured on single fasting venous sampling at 6- and 12-month follow up to determine the rate of biochemical remission in patients treated with EES or CAB
研究概览
简要总结
To determine the non-inferiority of EES with respect to CAB (standard care) for the rate of biochemical remission (defined as prolactin normalization in the absence of treatment) at 6- and 12-month follow-up, in newly diagnosed, treatment naïve patients with m-PRL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Patients with a diagnosis of microprolactinoma
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •age > 18 years old
- •signed informed consent
- •male or female gender
- •clinical manifestations suggestive for hyperprolactinemia
- •prolactin levels above upper lower limits confirmed at >2 single determinations, and at serial determinations (prolactin curve)
- •exclusion of macroprolactin
- •exclusion of other endogenous or iatrogenic causes of hyperprolactinemia, according to the Endocrine Society Guidelines
- •evidence of a pituitary adenoma with maximum diameter = 10 mm (m-PRL) at the MRI with g.c.m.
- •patient able to understand the study purpose, to give informed written consent, and to respond to self-administered questionnaires
- •no previous medical, surgical or radiation treatment for hyperprolactinemia
排除标准
- •contraindications to general anesthesia or surgery
- •contraindications to CAB
- •pregnancy at the time of randomization
- •clinical and/or biochemical evidence of concomitant secretion of other pituitary hormones (i.e., GH, TSH, FSH/LH and/or ACTH) by the microadenoma
- •prior surgery or radiotherapy to the skull base and/or hypothalamic-pituitary area
- •prior CAB treatment
- •concomitant treatment with other dopamine agonists
- •patient unable to understand the study purpose and/or to give informed written consent and/or to respond to self-administered questionnaires
- •other medical conditions that to the opinion of physicians are not compatible with inclusion in a trial
结局指标
主要结局
Prolactin levels will be measured on single fasting venous sampling at 6- and 12-month follow up to determine the rate of biochemical remission in patients treated with EES or CAB
Prolactin levels will be measured on single fasting venous sampling at 6- and 12-month follow up to determine the rate of biochemical remission in patients treated with EES or CAB
次要结局
- To determine m-PRL remnant at MRI with g.c.m. performed at 6 and 12 months after EES or starting CAB. MRI with g.c.m will be performed at study enrollment (baseline) and at 6- and 12- month follow-up to evaluate m-PRL diameters, so the ability of EES and CAB to reduce tumor mass.
- To determine in patients treated with CAB the rate of drug resistance (defined as failure to achieve normal prolactin levels and a reduction of adenoma size <50% on maximally tolerated doses after at least 6 months of treatment) through the measurement of prolactin levels at baseline and at 6- and 12-month follow-up.
研究者
Principal Investigator
Scientific
Azienda Unita Sanitaria Locale Di Bologna
研究点 (1)
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