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Cardiovascular Events in GnRH Agonist vs. Antagonist

NCT04182594 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-12-02

No results posted yet for this study

Summary

The purpose of this study is to test if the use of Degarelix for 1 year associated with a lower rate of cardiovascular toxicity compared to Gonadotropin-releasing hormone (GnRH) agonists in patients with advanced prostate cancer and cardiovascular risk factors, receiving combination therapy of Androgen deprivation therapy (ADT) and second line hormonal or chemotherapy?

Conditions

Interventions

DRUG

Degarelix

Treatment will start with two injections of 120 mg each followed by maintenance of a single injection of 80 mg administered every 28 days

DRUG

GnRH agonist

GnRH agonist at the discretion of the treating Urologist/Oncologist for 1 year

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    collaborator INDUSTRY

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • David Margel, MD, PhD · Rabin Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-17
Primary Completion
2023-01-17
Completion
2023-01-17

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04182594 on ClinicalTrials.gov