Ferring 000108 PRONOUNCE

• Research type

  Research Study

• Full title

  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 (GnRH Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist)

• IRAS ID

  241904

• Contact name

  Anders Neijber

• Contact email

  Anders.Neijber@ferring.com

• Sponsor organisation

  Ferring Pharmaceuticals A/S

• Eudract number

  2017-002495-20

• Clinicaltrials.gov Identifier

  NCT02663908

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  3 years, 10 months, 4 days

• Research summary

  This is a multi-centre, randomised, assessor-blind, controlled trial. The purpose of this study is to assess whether there is a difference in risk of cardiovascular (conditions of the heart, vessels or circulation) complication between two drugs already marketed for advanced prostate cancer (degarelix and leuprolide) in patients with both prostate cancer and cardiovascular disease. Prostate cancer cells depend on testosterone to grow, the study drugs work by suppressing the production of testosterone, which ultimately slows the growth of the prostate cancer cells. They do this in one of two ways:

  1. Interfering or inhibiting the testosterone
  2. Inhibits the response of testosterone by combining with the receptor.

  Participants taking part in the study will be randomly assigned to receive one of the two treatments at a 1:1 ratio.

  1. 12 doses of Firmagon (degarelix) injection; first dose of 240mg in two injections and then 11 doses of 80mg at monthly intervals starting 1 month after the first dose
  2. 4 doses of Lupron (leuprolide) injection, one injection every 3 months of 22.4mg each

  The study consists of a screening period, randomisation and 12 month treatment/follow up period. The participant will remain in the study for 12 months and will visit the clinic 14 times in total.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  18/ES/0071

• Date of REC Opinion

  17 Jul 2018

• REC opinion

  Further Information Favourable Opinion