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Prostate cancer showdown: which hormone therapy plus radiation delays progression best?

NCT ID NCT02799706

Disease control Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial compares two hormone therapies (GnRH antagonist vs GnRH agonist) given alongside radiation for men with very high-risk localized or locally advanced prostate cancer. The main goal is to see which combination better delays cancer progression. The study enrolled 885 participants and is no longer recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Degarelix (GnRH antagonist) or approved GnRH agonist plus anti-androgen flare protection, combined with radiotherapy
What this could lead to
If successful, this could show that one hormone therapy works better than the other at delaying cancer progression when combined with radiation.
What could go wrong
This is a large Phase 3 trial, but results may not apply to all prostate cancer patients. Both treatments have side effects, and the study is not designed to prove a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 885 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2017

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) * 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. Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

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

    Meldola, 47014, Italy

  • AZ Groeninge Kortrijk - Campus Kennedylaan

    Kortrijk, 8500, Belgium

  • Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

    Paris, 75651, France

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134, Italy

  • CHU Ucl Namur - Site Sainte-Elisabeth

    Namur, 5000, Belgium

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

    Grenoble, 38043, France

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

    Bayonne, 64100, France

  • Centre Hospitalier Privé Saint-Grégoire

    Saint-Grégoire, 35760, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Centre de radiotherapie Marie Curie

    Arras, 6200, France

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, 12200, Germany

  • Clinica IMQ Zorrotzaurre

    Bilbao, 48014, Spain

  • Clinique Pasteur-Toulouse-Atrium

    Toulouse, BP27617, France

  • Clinique de l'Europe

    Amiens, 80090, France

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Complejo Hospitalario A

    Pamplona, Spain

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

    Vigo, 36312, Spain

  • Corporacio Sanitaria Parc Tauli

    Sabadell, 08208, Spain

  • Fundacion Hospital Alcorcon

    Alcorcón, 28922, Spain

  • Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus

    Wilrijk, 2610, Belgium

  • Groupe Radiopole Artois - Centre de Radiotherapie Pierre Curie

    Beuvry, 62660, France

  • Hopital De Jolimont

    Haine-Saint-Paul, 7100, Belgium

  • Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

    Brussels, 1070, Belgium

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

    Brussels, 1000, Belgium

  • Hospital Consorci Sanitari De Terrassa

    Terrassa, 08227, Spain

  • Hospital General Universitario Santa Lucia

    Cartagena, 30202, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas de Gran Canaria, 35010, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

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

    Geneva, Switzerland

  • Inselspital

    Bern, 3010, Switzerland

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

    Barcelona, 08916, Spain

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

    Nantes, 44805, France

  • Nottingham University Hospitals NHS Trust - City Hospital

    Nottingham, NG5 1PB, United Kingdom

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

    Bellinzona, 6500, Switzerland

  • Otto-Von-Guericke-Universitaet Magdeburg - Universitaetsklinik

    Magdeburg, 39120, Germany

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitair Ziekenhuis Brussel

    Brussels, 1090, Belgium

  • University Hospitals Copenhagen - Rigshospitalet

    Copenhagen, 2100, Denmark

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