Clinical trial · Observational
Dopamine Agonists Withdrawal Study of Invasive Prolactinomas Involving the Cavernous Sinus
NCT02536261CI-TRIAL-00027598unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to observe whether dopamine agonists can be safely withdrawn after the tumor volume and prolactin level of invasive prolactinomas involving the cavernous sinus have been effectively controlled through pharmacological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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Prolactinomas Involving the Cavernous Sinus | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Withdrawal group
- description
- Withdrawal observation after reaching the withdrawal standard
- label
- Continue treatment group
- description
- Continue treatment obsevation after reaching the withdrawal standard
Primary outcomes (1)
- measure
- Change from baseline on PRL level
- timeFrame
- Up to 2 years
- description
- Record the result of PRL on every 3 month follow-up visit
Secondary outcomes (3)
- measure
- Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging(MRI)
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDWu 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. PMID 16509147
- BACKGROUNDWu 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. PMID 17917811