PRolaCT - Three Multicenter Prolactinoma Randomized Clinical Trials
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 880
- 试验地点
- 3
- 主要终点
- Health-Related Quality of Life
研究概览
简要总结
This study aims to investigate if endoscopic trans-sphenoidal prolactinoma resection as a first line treatment, or as an equally valid second line treatment after a short (4-6 months) or long (>2 years) period of pretreatment with a dopamine agonist is superior to standard care for several outcome parameters. The main objectives are to investigate this for quality of life and remission rate. The secondary objectives are to investigate this for biochemical disease control, recurrence rates, clinical symptom control, tumor shrinkage on MRI, pituitary functioning, the occurrence of adverse reactions to treatment, disease burden, and cost-effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age.
- •A history of signs and symptoms compatible with the diagnosis prolactinoma.
- •New, recent (PRolaCT-1) or known diagnosis of hyperprolactinaemia, defined as a prolactin level 2 times the local laboratory maximum. At the time of randomization hyperprolactinaemia is still present, or was present < 12 months before inclusion (PRolaCT-2 and PRolaCT-3).
- •No clear alternative explanation for hyperprolactinaemia, e.g. medication use.
- •Presence of a clearly identifiable (persisting) pituitary mass on MRI not invading the cavernous sinus and having an optimal chance to be completely resected (generally adenomas with a maximum diameter nog exceeding 25mm). A representative MRI at the time of randomization is required, this MRI should generally not be older than 12 months in PRolaCT-3 and 2 months in PRolaCT-1 and PRolaCT-
- •Competent and able to fill in questionnaires.
- •One of the following, dividing patients in to our three RCTs:
- •PRolaCT-1: no prior treatment for prolactinoma;
- •PRolaCT-2: treatment with a dopamine agonist for 4-6 months; or
- •PRolaCT-3: treatment with a dopamine agonist for at least 2 years.
排除标准
- •Contraindication for one of the treatment modalities, e.g. severe side effect of cabergoline, contraindications to surgery, or a clear indication for surgical resection.
- •Pregnancy at the time of randomization.
- •Clinical acromegaly.
- •Prior pituitary gland surgery or radiotherapy to the pituitary gland area.
- •Severe renal failure (eGFR <30 ml/min).
- •Insufficient understanding of the Dutch or English language.
- •Other medical conditions that to the opinion of the physician are not compatible with inclusion in a trial.
- •Patients eligible for participation in one of the RCTs, but do not consent to randomisation or in whom there is a clear patient or physician preference for either DA treatment or surgery, are considered for participation in PRolaCT-O.
研究组 & 干预措施
Intervention
Patients in the intervention groups will be referred to one of the participating neurosurgical centers, for surgical consultation. After this consultation, the patient may choose to continue with surgery or not.
干预措施: Endoscopic trans-sphenoidal adenoma resection (Procedure)
Standard care
Patients in the standard care groups will receive treatment as usual as described by the US Endocrine Society.
干预措施: Dopamine Agonists (Drug)
结局指标
主要结局
Health-Related Quality of Life
时间窗: 12 months after randomization/baseline
Health-Related Quality of Life is defined as the score on the mental health scale of the Medical Outcomes Study (MOS) Short-Form Health Survey (SF-36), measured at T=12.
Long-term remission
时间窗: 36 months after randomization/baseline
Disease remission is defined as normoprolactinaemia (a prolactin level below the upper limit of normal as defined by the laboratory site where it is measured), in the absence of dopamine agonist treatment for at least 3 months or an actual pregnancy that was established during at least 3 months absence of dopamine agonist treatment, measured at T=36.
次要结局
- Biochemical disease control(12 months after randomization/baseline)
- Short-term remission(27 months after randomization/baseline)
- Very long-term remission(60 months after randomization/baseline)
- Recurrence rate(36 and 60 months after randomization/baseline)
- Side effects(Baseline and 12, 27 and 36 months after randomization/baseline)
- Clinical symptom control(12, 27, 36 and 60 months after randomization/baseline)
- Tumor shrinkage on MRI(12 and 36 months after randomization/baseline)
- Pituitary functioning(12 and 36 months after randomization/baseline)
- Complications(Baseline and 12 months after randomization/baseline)
- Depression and anxiety scores(baseline and 12 and 36 months after randomization/baseline)
- Healthcare costs(Every 6 months until 36 months after randomization/baseline)
- Health-Related Quality of Life(Baseline and 12, 27, 36 and 60 months after randomization/baseline)
- Disease burden(baseline and 12, 36 and 60 months after randomization/baseline)
- Non-healthcare costs(Every 6 months until 36 months after randomization/baseline)
- Quality-Adjusted Life Years (QALYs)(Baseline and 6, 9, 12, 18, 24, 27, 30 and 36 months after randomization/baseline)
研究者
I.M. Zandbergen, MD
Coordinating Investigator
Leiden University Medical Center