Dopamine Agonists Withdrawal Study of Invasive Prolactinomas Involving the Cavernous Sinus

The purpose of this study is to observe whether dopamine agonists can be safely withdrawn after the tumor volume and prolactin level of invasive prolactinomas involving the cavernous sinus have been effectively controlled through pharmacological treatment.

Study Overview

• Status: Unknown
• Conditions: Invasive Prolactinomas Involving the Cavernous Sinus

Detailed Description

For giant or large invasive prolactinomas involving the cavernous sinus, whether the drug can be safely withdrawn after the tumor volume and prolactin(PRL) level have been effectively controlled through pharmacological treatment still remains unknown. The study objects are patients with invasive prolactinomas involving the cavernous sinus, which were invaded the cavernous sinus to an extent corresponding to Grade III or IV, according to the classification scheme of Knosp and colleagues, who had undergone pharmacological treatment including bromocriptine or cabergoline. Observation will be started after drug withdrawal criteria are reached (PRL remains normal level for no less than two years; tumor volume has shrank more than 50%, and the distance is more than 5mm between tumor and optical nerve),the patients are randomized to withdrawal group or continue treatment group.Observational items include changes of PRL level, tumor volume as well as vision acuity and visual fields. If elevated PRL or tumor relapse is observed, pharmacological treatment will be restarted.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Zhebao Wu, Medical PhD; Phone Number: 666091 21-64370045; Email: zhebaowu@aliyun.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Tiantan Hospital
  • Chongqing
    • Chongqing, Chongqing, China
      • Recruiting
      • Xinqiao Hospital of Chongqing
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • First Affiliated Hospital of Fujian Medical University
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • The First Hospital of China Medical University
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Huashan Hospital
    • Shanghai, Shanghai, China, 200025
      • Enrolling by invitation
      • Ruijin Hosipital
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • Recruiting
      • First affiliated hospital of Wenzhou medical university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

invasive prolactinomas involving the cavernous sinus

Description

Inclusion Criteria:

1. Aged between 15 and 70 years old, either sex;
2. Karnofsky performance status ≥ 70;
3. Patients who were suffered Invasive prolactinomas involving the cavernous sinus , referring to ①Serum prolactin level>200ng/ml, or >4000mIU/L;②enhanced Magnetic Resonance images confirm tumor invasion into cavernous sinus, i.e. Knosp grade Ⅲ or Ⅳ, and were treated by dopamine agonists treatment;
4. PRL remains normal level for no less than two years;
5. Tumor volume has shrank more than 50%, and the distance is more than 5mm between tumor and optical nerve;
6. The patient has signed the informed consent.

Exclusion Criteria:

1. Patients concomitantly taking the psychotropic drugs or other drugs causing elevated PRL ;
2. Patients with parkinson disease and is taking dopaminergic agents;
3. Patients with prolactinoma who received Gamma knife treatment;
4. Patients who use any dopamine receptor agonists other than bromocriptine and cabergoline;
5. Patients taking the other prolactinomas simultaneously;
6. pregnant or lactating women, or women preparing pregnant;
7. Patients with poor compliance, who cannot implement the program strictly.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Withdrawal group; Withdrawal observation after reaching the withdrawal standard
Continue treatment group; Continue treatment obsevation after reaching the withdrawal standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline on PRL level	Record the result of PRL on every 3 month follow-up visit	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）	Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visits	Up to 2 years
Change from baseline of visual acuity	Record the Visual acuity on every 3 month follow-up visit	Up to 2 years
Change from baseline on 5 point visual field scale	Record the Visual field scale on every 3 month follow-up visit, 0 = normal, no vision loss; 1 = one quadrant vision loss; 2 = two quadrants of vision loss; 3 = three quadrants of vision loss; 4 = four quadrants of vision loss but retain a central tubular vision; 5 = blind	Up to 2 years

Collaborators and Investigators

• Sponsor: Zhebao Wu
• Collaborators: Peking Union Medical College Hospital; Beijing Tiantan Hospital; Huashan Hospital; First Affiliated Hospital of Fujian Medical University; Xinqiao Hospital of Chongqing; First Hospital of China Medical University; First Affiliated Hospital of Wenzhou Medical University
• Investigators: Study Chair: Zhebao Wu, Medical PhD, Ruijin Hospital

Publications and helpful links

General Publications

• Wu ZB, Yu CJ, Su ZP, Zhuge QC, Wu JS, Zheng WM. Bromocriptine treatment of invasive giant prolactinomas involving the cavernous sinus: results of a long-term follow up. J Neurosurg. 2006 Jan;104(1):54-61. doi: 10.3171/jns.2006.104.1.54.
• Wu ZB, Su ZP, Wu JS, Zheng WM, Zhuge QC, Zhong M. Five years follow-up of invasive prolactinomas with special reference to the control of cavernous sinus invasion. Pituitary. 2008;11(1):63-70. doi: 10.1007/s11102-007-0072-4.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 15, 2015
• First Submitted That Met QC Criteria: August 26, 2015
• First Posted (Estimate): August 31, 2015

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: dopamine agonist; withdrawal; Prolactinoma; cavernous sinus
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Hypothalamic Diseases; Pituitary Diseases; Adenoma; Pituitary Neoplasms; Prolactinoma
• Other Study ID Numbers: WSIP-1586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The individual patient Data would not be shared to the third facility, but the sponsor hasn't decided whether to share the individual patient date to the other related studies hold by himself in the future.