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Lo studio clinico NCT06908694 (GAINPCCONTROL) per CANCRO ALLA PROSTATA è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Investigation of GLP1-Receptor Agonists in Men With Prostate Cancer Taking Androgen Deprivation Therapy (GAINPCCONTROL) Fase IV 20

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06908694 (GAINPCCONTROL) è uno studio interventistico di Fase IV volto a esaminare il trattamento per CANCRO ALLA PROSTATA, attualmente in arruolamento. Avviato il 2 luglio 2025, prevede di arruolare 20 partecipanti. Sotto la guida di Hamilton Health Sciences Corporation, dovrebbe concludersi entro il 31 luglio 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 29 luglio 2025.
Sommario breve
GAIN PC CONTROL is a study investigating Glucagon-Like Peptide-1 Receptor Agonists in men with prostate cancer who are being treated with androgen deprivation therapy.
Descrizione dettagliata
GAIN PC CONTROL is an open-label single-arm phase IV trial that will evaluate 1) the safety and tolerability of Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) in men with prostate cancer (PC) treated with androgen deprivation therapy (ADT); 2) the effects of GLP-1 RAs on weight, waist circumference, blood pressure, HbA1c, lipids, PSA and Creatinine, estimated glomerular filtration rate in men with PC treated w...Mostra di più
Titolo ufficiale

GLP1-Receptor Agonists in Men With Prostate Cancer: Control of Cardiovascular Risk Factors and Prostate Biomarkers

Patologie
CANCRO ALLA PROSTATA
Altri ID dello studio
  • GAINPCCONTROL
  • 5100
Numero NCT
NCT06908694
Data di inizio (effettiva)
2025-07-02
Ultimo aggiornamento pubblicato
2025-07-29
Data di completamento (stimata)
2026-07-31
Arruolamento (previsto)
20
Tipo di studio
Interventistico
FASE
Fase IV
Stato
In arruolamento
Parole chiave
Androgen Deprivation Therapy
GLP-1 Receptor Agonists
Scopo principale
Trattamento
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleSemaglutide
The semaglutide dose will be 0.25mg subcutaneously once weekly for weeks 1-4, then 0.5mg once weekly for weeks 5-8, then 1mg once weekly for weeks 9-12, then 1.7mg once weekly for weeks 13-16, and then 2.4mg for the remainder of the trial. Semaglutide dose may be decreased in the case of adverse events to the highest tolerated dose.
Semaglutide Pen Injector
The semaglutide dose will be 0.25mg subcutaneously once weekly for weeks 1-4, then 0.5mg once weekly for weeks 5-8, then 1mg once weekly for weeks 9-12, then 1.7mg once weekly for weeks 13-16, and then 2.4mg for the remainder of the trial. Semaglutide dose may be decreased in the case of adverse events to the highest tolerated dose.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Number of Serious Adverse Events
An event that leads to death; is life-threatening; results in hospitalization or its prolongation; disability or permanent damage; congenital anomaly or birth defect; or other medical event that is considered serious.
12 months
Number of Adverse Events leading to Drug Discontinuation
Adverse Events leading to Drug Discontinuation
6 months
Measure of Weight
Measure of Weight
12 months
Measure of Waist Circumference
Measure of Waist Circumference
12 months
Measure of Blood Pressure
Measure of Blood Pressure
12 months
Concentration of HbA1c
Concentration of HbA1c
12 months
Concentration of Lipids
Total Cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides
12 months
Concentration of PSA
Concentration of PSA
12 months
Concentration of Creatinine
Concentration of Creatinine
12 months
Calculation of estimated glomerular rate
Calculation of estimated glomerular rate
12 months
Number of Clinical Outcomes
Death, Hospitalization, New Diabetes, Myocardial Infarction, Stroke, Heart Failure, Peripheral Arterial Disease, Venous Thromboembolism
12 months
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Maschio

  • Have a physician diagnosis of PC

  • Must be receiving or planned to receive ADT (gonadotropin releasing hormone agonist or antagonist ± androgen receptor pathway inhibitor)

  • Elevated BMI

    1. ≥30kg/m2 or
    2. ≥27kg/m2 in the presence of at least one of hypertension, type 2 diabetes, obstructive sleep apnea or dyslipidemia

  • Type 1 diabetes
  • Taking a GLP-1 RA
  • <18 years of age
  • History of pancreatitis
  • Personal or family history of medullary cancer of the thyroid
  • Multiple endocrine neoplasia type 2
Hamilton Health Sciences Corporation logoHamilton Health Sciences Corporation
McMaster University logoUniversità McMaster
Contatti principali dello studio
Contatto: Sarah Karampatos, BASc, MSc, 905-296-5795, [email protected]
Contatto: Steven Agapay, BSc, 905-296-5764, [email protected]
1 Centri dello studio in 1 paesi

Ontario

Juravinski Cancer Centre, Hamilton, Ontario, L8V1C3, Canada
Nadra Yasmin, Contatto, [email protected]
Shauna Szendrey, Contatto, [email protected]
Darryl Leong, MBBs,MPH,PhD,FRACP,FESC, Investigatore principale
Jehonathan Pinthus, MD,FRCS(C),PhD, Investigatore principale
In arruolamento