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AzTrials

Prostate CancerPhase 3PEGASUSNCT02799706

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 Phase 3 study testing Degarelix, approved GnRH agonist and Radiotherapy in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 39 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The primary objective of the trial is to assess if GnRH antagonists in combination with external beam radiation therapy improve progression free survival (progression that can be biological, clinical, or death) compared to GnRH agonists in combination with external beam radiation therapy. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Degarelix, approved GnRH agonist and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
885 participants
Where
39 sitesin 8 countries
Study dates
25 Sep 2017to 30 Jun 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of prostate adenocarcinoma
  • PSA ≥ 10 ng/ml and two of the following 4 criteria:
  • PSA ≥ 20 ng/ml,
  • Gleason sum ≥ 8,
  • cN1 (regional LN with a short axis length >10mm by CT scan or MRI) or pathologically confirmed lymph nodes (pN1),
  • cT3-T4 (by MRI or core biopsy) (i.e. If PSA≥ 20 ng/ml then only one of the other 3 risk factors is needed)
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  • M0 by standard imaging work-up (see chapter 6.1.1.1)
  • Testosterone ≥ 200 ng/dl
  • Adequate renal function: calculated creatinine clearance ≥ 50 mL/min (Appendix D) Magnesium and potassium within normal limits of the institution or corrected to within normal limits prior to the first dose of treatment.
  • Patients with prolonged QT-intervals due to prescribed Class IA (quinidine, procainamide) or Class III (amiodarone, sotalol) antiarrhythmic medication must be carefully evaluated for GnRH-agonist or GnRH antagonist use, because these drugs may prolong the QT-interval.
  • WHO Performance status 0-1
  • Age ≥ 18 and ≤ 80 years
  • Participants who have partners of childbearing potential must use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 3 months after last dose of study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly
  • Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.

Who cannot join

  • Previous use of androgen deprivation therapy (ADT), antiandrogens. 5-alpha reductase inhibitors are allowed if interrupted for more than 6 months prior to entering the study
  • History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema.
  • Hypersensitivity towards the investigational drug
  • The following biological parameters :AST, ALT, total bilirubin, prothrombin time, serum albumin above upper level of normal range No severe hepatic impairment (Child Pugh C)
  • History of gastro-intestinal disorders (medical disorder or extensive surgery) that may interfere with the absorption of the protocol treatment.
  • History of pituitary or adrenal dysfunction
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  • Uncontrolled diabetes mellitus
  • History of ulcerative colitis, Crohn's Disease, ataxia, telangiectasia, systemic lupus erythematous, or Fanconi anemia.
  • Clinically significant heart disease as evidence myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline
  • Coronary revascularization (PCI or multivessel CABG), carotid artery or iliofemoral artery revascularization (percutaneous or surgical procedure) within the last 30 days prior to entering the trial
  • Certain risk factors for abnormal heart rhythms/QT prolongation: torsade de pointes ventricular arrhythmias (e.g, heart failure, hypokalemia, or a family history of a long QT syndrome), a QT or corrected QT (QTc) interval >450 ms at baseline, or intake of medications that prolong the QT/QTc interval
  • Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
  • Prior history of malignancies other than prostate adenocarcinoma (except patients with basal cell, squamous cell carcinoma of the skin), or the patient has been free of malignancy for a period of 3 years prior to first dose of study drug(s). Prior history of bladder cancer excludes the patient.
  • Prior radical prostatectomy (TURP or suprapubic adenomectomy for benign prostatic hyperplasia is allowed)
  • Prior brachytherapy or other radiotherapy that would result in an overlap of radiotherapy fields
  • Any contraindication to external beam radiotherapy
  • Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial

Trial locations and contacts

39 sites in 8 countries.

39 sites in 8 countries

Spain11 sites

  • Fundacion Hospital Alcorcon

    Alcorcón, 28922

  • Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

    Barcelona, 08916

  • Clinica IMQ Zorrotzaurre

    Bilbao, 48014

  • Hospital General Universitario Santa Lucia

    Cartagena, 30202

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas de Gran Canaria, 35010

  • Complejo Hospitalario A

    Pamplona

  • Corporacio Sanitaria Parc Tauli

    Sabadell, 08208

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Consorci Sanitari De Terrassa

    Terrassa, 08227

  • Complejo Hospitalario Universitario de Vigo -CHUVI - Hospital Alvaro Cunqueiro

    Vigo, 36312

Other trials in Spain

France10 sites

  • Clinique de l'Europe

    Amiens, 80090

  • Centre de radiotherapie Marie Curie

    Arras, 6200

  • Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque

    Bayonne, 64100

  • Groupe Radiopole Artois - Centre de Radiotherapie Pierre Curie

    Beuvry, 62660

  • CHU de Grenoble - La Tronche - Hôpital A. Michallon

    Grenoble, 38043

  • Centre Leon Berard

    Lyon, 69008

  • Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau

    Nantes, 44805

  • Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

    Paris, 75651

  • Centre Hospitalier Privé Saint-Grégoire

    Saint-Grégoire, 35760

  • Clinique Pasteur-Toulouse-Atrium

    Toulouse, BP27617

Other trials in France

Belgium8 sites

  • Hopitaux Universitaires Bordet-Erasme - Hopitaux Universitaires Bordet- Institut Jules Bordet

    Brussels, 1000

  • Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

    Brussels, 1070

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Hopital De Jolimont

    Haine-Saint-Paul, 7100

  • AZ Groeninge Kortrijk - Campus Kennedylaan

    Kortrijk, 8500

  • CHU Ucl Namur - Site Sainte-Elisabeth

    Namur, 5000

  • Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

Germany3 sites

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, 12200

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Otto-Von-Guericke-Universitaet Magdeburg - Universitaetsklinik

    Magdeburg, 39120

Other trials in Germany

Switzerland3 sites

  • Oncology Institute of Southern Switzerland (IOSI) - Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli

    Bellinzona, 6500

  • Inselspital

    Bern, 3010

  • Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie

    Geneva

Other trials in Switzerland

Italy2 sites

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

  • AUSL Romagna - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

Other trials in Italy

Denmark1 site

  • University Hospitals Copenhagen - Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

United Kingdom1 site

  • Nottingham University Hospitals NHS Trust - City Hospital

    Nottingham, NG5 1PB

Other trials in United Kingdom

About this study

Official 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

The primary objective of the trial is to assess if GnRH antagonists in combination with external beam radiation therapy improve progression free survival (progression that can be biological, clinical, or death) compared to GnRH agonists in combination with external beam radiation therapy.

Secondary objectives include:

  • documentation of effect of GnRH antagonists on clinically significant cardiovascular events in the subgroup of patients at high risk of such events at baseline;
  • documentation of side effects and quality of life, I-PSS and urinary tract infections;
  • assessment of relative treatment effect on secondary efficacy endpoints (clinical progression, time to next line of systemic therapy, time on therapy, overall and cancer specific survival) and on PSA at 6 months after end of RT.
Read the detailed description

Phase IIIb randomized stratified open-label comparative 2-arm superiority study with a pre-set non-inferiority boundary.

Registered GnRH antagonists, degarelix, will be given at the dose of 240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL on day 1, followed by 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL every 28 days (±2 days).

External beam radiotherapy (EBRT) to a total dose of 78-80 Gy, delivered as one daily fraction, five days a week, started between d1 and months 6 of the androgen deprivation therapy as per institution policy. The irradiation is the same as in the reference therapy arm.

The minimum duration of androgen deprivation with GnRH agonist or antagonist therapy is 18 months.

For each patient, the duration of therapy must be elected upfront by the treating physician among three possible options: 18, 24 or 36 months. The institution shall also declare upfront the duration of the neoadjuvant treatment they intend to deliver to each patient (between 0 and 6 months).

The primary endpoint is progression-free survival defined as the time in days from randomization to death, clinical or biochemical progression, whichever comes first.

Where

  • PSA progression based on Phoenix definition, i.e. a rise by 2 ng/mL or more above the nadir PSA (Ref. 17) confirmed by a second value measured minimum 3 months later
  • Clinical progression is defined as onset of obstructive symptoms requiring local treatment and demonstrated to be caused by cancer progression or evidence of metastases detected by clinical symptoms and confirmed by imaging
  • Start of another line of systemic therapy in absence of progression
  • Death due to any cause

Secondary endpoints:

  • Clinical progression-free survival
  • Time to next systemic anticancer therapy (including secondary hormonal manipulation)
  • Proportion of patients switching from GnRH antagonists to GnRH agonists and total effective duration of treatment with the originally allocated drug.
  • Overall survival
  • Cancer specific survival
  • PSA at six months after completion of RT Safety will be scored by the CTCAE version 4.0. The major safety endpoints in this study are
  • the incidence of clinical cardiovascular events - CCE (i.e. arterial embolic or thrombotic events, hemorrhagic or ischemic cerebrovascular conditions, myocardial infarction, and other ischemic heart disease) in patients who had cardiovascular events before entering the trial and in those without such events.
  • Incidence of urinary tract infection
Conditions
Prostate Cancer
Being tested
Degarelix, approved GnRH agonist, Radiotherapy
Keywords
Prostate cancer, GnRH antagonist, GnRH agonist, radiation therapy, very high risk localized prostate cancer, locally advanced prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DegarelixDrug

    a GnRH antagonist will be given for a predefined duration of 18, 24, or 36 months as per institution policy

  • approved GnRH agonistDrug

    A non-steroidal anti-androgen (e. g. flutamide, bicalutamide) will be given orally one week before the first injection of the GnRH agonist and will be continued for no longer than 8 weeks to protect against flare.Dose may vary due to availability of different brand names and pharmaceutical forms The start of antiandrogen must be registered as day 1 of treatment in the GnRH agonist arm.

  • RadiotherapyRadiation

    .As the study investigates the effect of two drugs given concomitantly to radiotherapy, all patients will be treated with the same treatment technique and target dose. The preferred treatment technique is intensity modulated radiotherapy (IMRT)

Study groups in NCT02799706
Study groupRoleWhat they receive
GnRH agonist + radiation therapy (RT)Active comparatorAs the study investigates the effect of a drug given concomitantly to radiotherapy, all patients will be treated with the same treatment technique and target dose. The preferred treatment technique is intensity modulated radiotherapy (IMRT) + A GnRH-agonist will be given for the duration selected for each patient. A non-steroidal anti-androgen (e. g. flutamide, bicalutamide) will be given orally one week before the first injection of the GnRH agonist and will be continued for no longer than 8 weeks to protect against flare. Dose may vary due to availability of different brand names and pharmaceutical forms The start of antiandrogen must be registered as day 1 of treatment in the GnRH agonist arm.
Receives: Drug: approved GnRH agonist; Radiation: Radiotherapy
GnRH antagonist + radiation therapy (RT)ExperimentalAs the study investigates the effect of two drugs given concomitantly to radiotherapy, all patients will be treated with the same treatment technique and target dose. The preferred treatment technique is intensity modulated radiotherapy (IMRT) +a GnRH antagonist will be given for a predefined duration of 18, 24, or 36 months as per institution policy. Each institution has to adhere to the chosen duration of treatment for all patients throughout the study
Receives: Drug: Degarelix; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    The primary endpoint is progression-free survival defined as the time in days from randomization to death, clinical or biochemical progression, whichever comes first.

    Where

    • PSA progression based on Phoenix definition, i.e. a rise by 2 ng/mL or more above the nadir PSA (Ref. 17) confirmed by a second value measured minimum 3 months later
    • Clinical progression is defined as onset of obstructive symptoms requiring local treatment and demonstrated to be caused by cancer progression or evidence of metastases detected by clinical symptoms and confirmed by imaging
    • Start of another line of systemic therapy in absence of progression
    • Death due to any cause

    Measured: through study completion, an average of 1 year

Secondary outcomes (6)

  1. Clinical progression-free survival

    Measured: through study completion, an average of 1 year

  2. Time to next systemic anticancer therapy (including secondary hormonal manipulation)

    Measured: through study completion, an average of 1 year

  3. ♦ Proportion of patients switching from GnRH antagonists to GnRH agonists

    Measured: through study completion, an average of 1 year

  4. ♦ Overall survival

    Measured: through study completion, an average of 1 year

  5. Incidence of clinical cardiovascular events

    ♦ the incidence of clinical cardiovascular events - CCE (i.e. arterial embolic or thrombotic events, hemorrhagic or ischemic cerebrovascular conditions, myocardial infarction, and other ischemic heart disease) in patients who had cardiovascular events before entering the trial and in those without such events.

    Measured: through study completion, an average of 1 year

  6. ♦ Incidence of urinary tract infection

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2016 (estimated)
  2. Study start25 Sep 2017
  3. Primary completion23 Aug 2023
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
885 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02799706
Sponsor's protocol ID
EORTC-1414
Acronym
PEGASUS
Status last verified
May 2026
First submitted
17 May 2016
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34350976

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Degarelix, approved GnRH agonist and Radiotherapy in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 39 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Spain, France, Belgium, Germany, Switzerland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02799706, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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