Surgical versus Medical Treatment in Microprolactinomas (SUMET PRO)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Unita Sanitaria Locale Di Bologna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19], Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2024-09-23

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-516383-28-01

EudraCT number

2023-000082-13

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Efficacy

To determine the non-inferiority of EES with respect to CAB (standard care) for the rate of biochemical remission (defined as prolactin normalization in the absence of treatment) at 6- and 12-month follow-up, in newly diagnosed, treatment naïve patients with m-PRL.

Secondary objectives 3

1. To determine 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), and of AEs, in patients treated with CAB. Potential predictors of drug resistance may be also investigated.
2. To determine m-PRL remnant at MRI with g.c.m. performed at 6 and 12 months after EES or starting CAB.
3. To determine the type and rate of surgical complications. Potential predictors of surgical complications may be also investigated.

Conditions and MedDRA coding

Microprolactinomas

Study design 1 period

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. age > 18 years old
2. male or female gender
3. clinical manifestations suggestive for hyperprolactinemia
4. prolactin levels above upper lower limits confirmed at >2 single determinations, and at serial determinations (prolactin curve)
5. exclusion of macroprolactin
6. exclusion of other endogenous or iatrogenic causes of hyperprolactinemia, according to the Endocrine Society Guidelines
7. evidence of a pituitary adenoma with maximum diameter = 10 mm (m-PRL) at the MRI with g.c.m.
8. patient able to understand the study purpose, to give informed written consent, and to respond to self-administered questionnaires
9. no previous medical, surgical or radiation treatment for hyperprolactinemia
10. signed informed consent

Exclusion criteria 9

1. contraindications to general anesthesia or surgery
2. contraindications to CAB
3. pregnancy at the time of randomization
4. clinical and/or biochemical evidence of concomitant secretion of other pituitary hormones (i.e., GH, TSH, FSH/LH and/or ACTH) by the microadenoma
5. prior surgery or radiotherapy to the skull base and/or hypothalamic-pituitary area
6. prior CAB treatment
7. concomitant treatment with other dopamine agonists
8. patient unable to understand the study purpose and/or to give informed written consent and/or to respond to self-administered questionnaires
9. other medical conditions that to the opinion of physicians are not compatible with inclusion in a trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 2

1. 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.
2. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Unita Sanitaria Locale Di Bologna

Sponsor organisation

Azienda Unita Sanitaria Locale Di Bologna

Address

Via Altura 3

City

Bologna

Postcode

40139

Country

Italy

Scientific contact point

Organisation

Azienda Unita Sanitaria Locale Di Bologna

Contact name

Principal Investigator

Public contact point

Organisation

Azienda Unita Sanitaria Locale Di Bologna

Contact name

Principal Investigator

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications