Skip to content

Surgical versus Medical Treatment in Microprolactinomas (SUMET PRO)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516383-28-01
Enrollment
88
Registered
2024-09-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microprolactinomas

Brief summary

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

Detailed description

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.

Interventions

Sponsors

Azienda Unita Sanitaria Locale Di Bologna
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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.

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026