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| ID | Type | Description | Link |
|---|---|---|---|
| 94925726.0.1001.0068 | Other Identifier | CAPPesq |
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This will be a multicenter, prospective, randomized, open-label trial with women harboring microprolactinomas and treatment naïve. The sample will be added consecutively and randomized into 2 unblinded groups: the high dosage group will receive a high cabergoline (CAB) dose for a period of ~6 months vs the standard dosage group, which will use the lowest needed dose of CAB to achieve normoprolactinemia for 2 years. The primary outcome will be remission rate.
Prolactinoma is the most common subtype of pituitary adenoma, and dopamine agonists are the gold standard for treatment, primarily CAB. The SPARAGMOS trial will be an interventional, randomized, open-label, multicenter study utilizing a high dose of CAB for ~6 months to suppress prolactin levels, with the hypothetical goal of achieving greater tumor apoptosis and remission rates. The control group will receive CAB for two years at the lowest dose necessary to achieve normoprolactinemia, as per current guidelines. Of note, for both groups, the final cumulative dose will be similar. The findings from this trial have the potential to inform and redefine future therapeutic strategies for microprolactinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIGH CAB dose | Experimental |
| |
| Conventional therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabergoline | Drug | Patients eligible for the study and randomized to the HIGH CAB arm will start oral CAB, 1 pill of 0.5mg, once a week. The dose will be increased by 0.5mg every week until the target dose of 3.5 mg/w. This initial low-dose-escalating regimen of 7 weeks will be used to prevent symptoms of intolerance. When 3.5 mg/w (1 pill every day) is reached, the patient must maintain this dose for 6 months. After this period, a 1-month de-escalation regime is implemented, reducing the dose by 1 mg/w (2 pills per week) until discontinuation. |
| Measure | Description | Time Frame |
|---|---|---|
| Remission | Compare laboratory and clinical recurrence of hyperPRL at 3, 6 and 12 months after CAB treatment in the high dosage group vs the standard dosage group (conventional treatment). Laboratory recurrence will be characterized after withdrawal from CAB treatment by the presence of PRL levels above 2x the normal upper limit of reference, after a previous period where PRL levels were within the normal range. At least two separate serum samples are needed to confirm recurrence. The time between samples will be more than a week to ensure sustained elevation. Clinical recurrence will be defined as the recrudescence of symptomatic hyperPRL. | 3, 6 and 12 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
Cisgender women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Glezer, MD, PhD | Contact | 55 11 995791108 | andrea.glezer@hc.fm.usp.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UFMG | Recruiting | Belo Horizonte | Brazil |
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| ID | Term |
|---|---|
| D015175 | Prolactinoma |
| D006966 | Hyperprolactinemia |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077465 | Cabergoline |
| ID | Term |
|---|---|
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Cabergoline | Drug | The standard dosage group will receive conventional treatment as recommended by current guidelines: a low dose of CAB enough to achieve normoPRL for 2 years. All patients will start CAB with 1 pill (0.5mg) once a week. The CAB dose can be adjusted during visits if hyperPRL is not resolved (maximum dose 2mg/w to prevent inclusion of resistant cases). The expected dose used for this arm during follow-up is between 0.5 and 1 mg/w. After completion of 2 years of treatment, all patients will have CAB withdrawn, irrespective of tumor reduction, PRL levels or last CAB dose used. |
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| Unesp | Recruiting | Botucatu | Brazil |
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| UNB | Recruiting | Brasília | Brazil |
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| Unicamp | Recruiting | Campinas | Brazil |
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| UFPR | Recruiting | Curitiba | Brazil |
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| UFG | Recruiting | Goiânia | Brazil |
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| CPC | Recruiting | Ponta Grossa | Brazil |
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| HCPA | Completed | Porto Alegre | Brazil |
| Hospital Moinhos de Vento | Recruiting | Porto Alegre | Brazil |
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| Sta Casa-RS | Recruiting | Porto Alegre | Brazil |
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| UFPE | Recruiting | Recife | Brazil |
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| USP-RP | Recruiting | Ribeirão Preto | Brazil |
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| UFRJ | Recruiting | Rio de Janeiro | Brazil |
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| HCFMUSP | Recruiting | São Paulo | Brazil |
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| Sta Casa-SP | Recruiting | São Paulo | Brazil |
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| Unifesp | Recruiting | São Paulo | Brazil |
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| D010911 |
| Pituitary Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D006964 | Hyperpituitarism |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |