NCT04182594

Brief 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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 2, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 17, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2023

Completed
Last Updated

December 2, 2019

Status Verified

October 1, 2019

Enrollment Period

3 years

First QC Date

October 24, 2019

Last Update Submit

November 27, 2019

Conditions

Hormone Sensitive Prostate CancerProstate CancerCardiac Event

Outcome Measures

Primary Outcomes (1)

  • time to first cardiovascular event

    To compare time to first cardiovascular event as estimated by the cumulated probability at the 1-year time-point of patients with advanced prostate cancer treated for one year with Degarelix vs. GnRH agonist. This will be a composite outcome composed of: Death, CVA, MI, TIA, cardiac emergency room visits, heart catheterization.

    1 year

Secondary Outcomes (10)

  • time to first MACCE event

    1 year

  • cardiac echocardiography

    1 year

  • Hormonal Profile

    1 year

  • NTproBNP levels

    1 year

  • Adverse events

    1 year

  • +5 more secondary outcomes

Study Arms (2)

Degarelix

EXPERIMENTAL

GnRH Antagonist

Drug: Degarelix

GnRH-agonist

ACTIVE COMPARATOR

GnRH Agonist

Drug: GnRH agonist

Interventions

DegarelixDRUG

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

Also known as: Firmagon
Degarelix
GnRH agonistDRUG

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

GnRH-agonist

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Locally advanced high-risk prostate cancer OR metastatic prostate cancer patients.
  • Patients are scheduled to receive a combination of either
  • primary ADT for 12 months + either chemotherapy with docetaxel OR
  • primary ADT for 12 months + second line hormonal treatment with abiraterone/ enzalutamide/ apalutamide
  • Patients with a medical history of either of the following:
  • Myocardial infarction
  • Ischaemic or haemorrhagic cerebrovascular conditions
  • Arterial embolic and thrombotic events
  • Ischaemic heart disease
  • Prior coronary artery or iliofemoral artery revascularization (percutaneous or surgical procedures)
  • Peripheral vascular disease (e.g. significant stenosis (ABPI\<0.9), claudication, prior vascular surgery/intervention(
  • Two out of three cardiovascular risk factors: hypertension, diabetes, current smoking.
  • Patients age 18-90 years.
  • Life expectancy of over 12 months.
  • WHO performance status of 0-2
  • +1 more criteria

You may not qualify if:

  • Prior use of ADT in past 6 months prior to randomization. We will, however, allow prior use of anti-androgens such as Casodex, Chimax, Drogenil, and Cyprostat.
  • Known allergic reaction to Degarelix.
  • Any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center - Beilinson Hospital

Petah Tikva, 4941492, Israel

Location

Related Publications (1)

  • Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.

    PMID: 34350976DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsCardiovascular Diseases

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamideGonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • David Margel, MD, PhD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaara Ber, PhD

CONTACT

972-39376551yaaraba1@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2019

First Posted

December 2, 2019

Study Start

January 17, 2020

Primary Completion

January 17, 2023

Study Completion

January 17, 2023

Last Updated

December 2, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)