EORTC 1414-ROG-GUCG (Pegasus)

  • Research type

    Research Study

  • Full title

    Phase IIIb randomized trial comparing irradiation plus long term adjuvant androgen deprivation with GnRH antagonist versus GnRH agonist plus flare protection in patients with very high risk localized or locally advanced prostate cancer. A joint study of the EORTC ROG and GUCG. Pegasus

  • IRAS ID

    244844

  • Contact name

    Santhanam Sundar

  • Contact email

    sundar@oncology.org

  • Sponsor organisation

    European Organisation for Research and Treatment of Cancer (EORTC)

  • Eudract number

    2015-005098-19

  • Clinicaltrials.gov Identifier

    NCT02799706

  • Duration of Study in the UK

    10 years, 0 months, 31 days

  • Research summary

    This study is for adults who have been diagnosed with very high risk or locally advanced prostate cancer.

    The purpose of the study is to find out if giving the hormone therapy (degarelix) (together with radiotherapy) is better than standard hormone therapy (together with radiotherapy) at controlling this type of cancer.

    This is measured by comparing the length of time that participants live without their disease worsening (progression-free survival).

    Current hormone therapy (GnRH agonists) together with radiotherapy has improved overall survival in this group of patients compared with hormone therapy alone. New developments with a different hormone therapy (GnRH antagonists, such as degarelix) offers the possibility of improving the activity against this type of cancer and reducing side effects.

    The study will compare the effects of degarelix with standard hormone therapy using clinical examinations, regular scans and blood tests.

    The study also assesses quality of life and has an optional translational research component where saliva samples will be genetically analysed to understand more about the side effects from hormone therapy.

    This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by the EORTC (European Organisation for Research and Treatment of Cancer), a non-profit organisation based in Brussels.

  • REC name

    South Central - Berkshire B Research Ethics Committee

  • REC reference

    19/SC/0014

  • Date of REC Opinion

    8 Apr 2019

  • REC opinion

    Further Information Favourable Opinion