A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients With Prostate Cancer and Cardiovascular Disease Receiving Degarelix (Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist) NCT02663908, Ferring 000108.

  • STATUS
    Recruiting
Updated on 2 September 2021

Summary

The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in patients with prostate cancer and cardiovascular disease.

Description

For more information contact Cheryl Zinar, Director of Clinical Research, Urologic Consultants of Southeastern PA, 610-667-0458, Czinar@ucsepa.com.

Details
Condition Major Adverse Cardiovascular Events
Clinical Study IdentifierTX196745
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Advanced prostate cancer
Indication to initiate androgen deprivation therapy (ADT)
Predefined cardiovascular disease

Exclusion Criteria

Previous or current hormonal management of prostate cancer (unless terminated at least 12 months prior to trial)
Acute cardiovascular disease in the previous 30 days
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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