🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Spain / NCT02799706
Active, not recruiting Phase 3

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

NCT02799706 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2017-09-25
Last updated
2026-05-22

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Degarelix →approved GnRH agonistRadiotherapy

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

approved GnRH agonist: 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.

Radiotherapy: .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 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.

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
Hopitaux Universitaires Bordet-Erasme - Hopitaux Universitaires Bordet- Institut Jules Bordet Brussels Belgium
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme Brussels Belgium
Universitair Ziekenhuis Brussel Brussels Belgium
Cliniques Universitaires Saint-Luc Brussels Belgium
Hopital De Jolimont Haine-Saint-Paul Belgium
AZ Groeninge Kortrijk - Campus Kennedylaan Kortrijk Belgium
CHU Ucl Namur - Site Sainte-Elisabeth Namur Belgium
Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus Wilrijk Belgium
University Hospitals Copenhagen - Rigshospitalet Copenhagen Denmark
Clinique de l'Europe Amiens France
Centre de radiotherapie Marie Curie Arras France
Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque Bayonne France
Groupe Radiopole Artois - Centre de Radiotherapie Pierre Curie Beuvry France
CHU de Grenoble - La Tronche - Hôpital A. Michallon Grenoble France
Centre Leon Berard Lyon France
Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau Nantes France
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere Paris France
Centre Hospitalier Privé Saint-Grégoire Saint-Grégoire France
Clinique Pasteur-Toulouse-Atrium Toulouse France
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin Berlin Germany
Universitaetsklinikum Freiburg Freiburg im Breisgau Germany
Otto-Von-Guericke-Universitaet Magdeburg - Universitaetsklinik Magdeburg Germany
Azienda Ospedaliero-Universitaria Careggi Florence Italy
AUSL Romagna - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola Italy
Fundacion Hospital Alcorcon Alcorcón Spain
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) Barcelona Spain
Clinica IMQ Zorrotzaurre Bilbao Spain
Hospital General Universitario Santa Lucia Cartagena Spain
Hospital Universitario Reina Sofia Córdoba Spain
Hospital Universitario de Gran Canaria Doctor Negrin Las Palmas de Gran Canaria Spain
Complejo Hospitalario A Pamplona Spain
Corporacio Sanitaria Parc Tauli Sabadell Spain
Hospital Universitario de Salamanca Salamanca Spain
Hospital Consorci Sanitari De Terrassa Terrassa Spain
Complejo Hospitalario Universitario de Vigo -CHUVI - Hospital Alvaro Cunqueiro Vigo Spain
Oncology Institute of Southern Switzerland (IOSI) - Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli Bellinzona Switzerland
Inselspital Bern Switzerland
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie Geneva Switzerland
Nottingham University Hospitals NHS Trust - City Hospital Nottingham United Kingdom

More European Organisation for Research and Treatment of Cancer - EORTC trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02799706 on ClinicalTrials.gov ↗ ← All trials in Spain