Prostate Cancer Clinical Trial
— PEGASUSOfficial 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
Verified date | March 2023 |
Source | European Organisation for Research and Treatment of Cancer - EORTC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 885 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Brussel | Brussel | |
Belgium | Cliniques Universitaires Saint-Luc | Brussels | |
Belgium | Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme | Brussels | |
Belgium | Hopitaux Universitaires Bordet-Erasme - Hopitaux Universitaires Bordet- Institut Jules Bordet | 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 | |
Denmark | University Hospitals Copenhagen - Rigshospitalet | Copenhagen | |
France | 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-Gregoire | |
France | Clinique Pasteur-Toulouse-Atrium | Toulouse | |
Germany | Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin | Berlin | |
Germany | Universitaetsklinikum Freiburg | Freiburg | |
Germany | Otto-Von-Guericke-Universitaet Magdeburg - Universitaetsklinik | Magdeburg | |
Italy | Azienda Ospedaliero-Universitaria Careggi | Firenze | |
Italy | AUSL Romagna - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola | |
Spain | 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 | |
Switzerland | 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 | Geneve | |
United Kingdom | Nottingham University Hospitals NHS Trust - City Hospital | Nottingham |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC |
Belgium, Denmark, France, Germany, Italy, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
through study completion, an average of 1 year | |
Secondary | Clinical progression-free survival | through study completion, an average of 1 year | ||
Secondary | Time to next systemic anticancer therapy (including secondary hormonal manipulation) | through study completion, an average of 1 year | ||
Secondary | ? Proportion of patients switching from GnRH antagonists to GnRH agonists | through study completion, an average of 1 year | ||
Secondary | ? Overall survival | through study completion, an average of 1 year | ||
Secondary | 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. | through study completion, an average of 1 year | |
Secondary | ? Incidence of urinary tract infection | through study completion, an average of 1 year |
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