Informations générales (source: ClinicalTrials.gov)
A Double-blind Randomised Phase III Trial Evaluating the Efficacy of ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability and Not Elected for Docetaxel or Androgen Receptor Targeted Agents
Interventional
Phase 3
UNICANCER (Voir sur ClinicalTrials)
avril 2022
septembre 2037
27 septembre 2024
This is a Phase III, international, multicentre, randomised, double-blinded placebo
controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in
castration-naïve de novo metastatic prostate cancer patients with vulnerable functional
ability who have not elected for docetaxel or other androgen receptor pathway inhibitors.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Karim FIZAZI | 23/05/2024 09:41:18 | Contacter | ||
| HOPITAL FOCH | Raffaele RATTA | 05/05/2025 07:12:09 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | Stéphane OUDARD, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Christophe TOURNIGAND | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Tenon | Ahmed KHALIL, MD | Contact (sur clinicalTrials) | |||
| GRPE HOSP DIACONESSES-CROIX ST-SIMON | Camille SERRATE, MD | Contact (sur clinicalTrials) | |||
| HIA BEGIN | Carole HELISSEY, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Delphine BORCHIELLINI, MD | Contact (sur clinicalTrials) | |||
| Centre Azuréen de Cancérologie - 06250 - Mougins - France | Philippe Ronchin, MD | Contact (sur clinicalTrials) | |||
| Centre CHV Vendée - 85925 - La Roche-sur-Yon - France | Frank PRIOU, MD | Contact (sur clinicalTrials) | |||
| Centre Eugène Marquis - 35042 - Rennes - France | Laurence Crouzet, MD | Contact (sur clinicalTrials) | |||
| Centre François Baclesse - 14076 - Caen - France | Florence JOLY, MD | Contact (sur clinicalTrials) | |||
| Centre Georges François Leclerc - 21079 - Dijon - France | Sylvain LADOIRE, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Cote basque - 64109 - Bayonne - France | Louis FRANCOIS, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Intercommunal de Toulon-La Seyne - Hôpital Ste Musse - 83056 - Toulon - France | Xavier TCHIKNAVORIAN, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Métropole Savoie - 73000 - Chambéry - France | Mélanie TADJ LESAGE, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Rodez - 12027 - Rodez - France | Guillermo REYES-ORTEGA, MD | Contact (sur clinicalTrials) | |||
| Centre Institut Bergonié - 22076 - Bordeaux - France | Guihem ROUBAUD, MD | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - 63011 - Clermont-Ferrand - France | Hakim MAHAMMEDI, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - 69373 - Lyon - France | Aude FLECHON, MD | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - 59000 - Lille - France | Aurélien CARNOT, MD | Contact (sur clinicalTrials) | |||
| CH Annecy Genevois - 74374 - Pringy - France | Mélodie CARBONNAUX, MD | Contact (sur clinicalTrials) | |||
| CHIC Quimper - 29107 - Quimper - France | Friederike SCHLURMANN, MD | Contact (sur clinicalTrials) | |||
| CHP Centre Saint Grégoire - 35760 - Saint Grégoire - France | Xavier ARTIGNAN, MD | Contact (sur clinicalTrials) | |||
| CHRU de Tours -Hôpital Bretonneau - 37044 - Tours - France | Claude LINASSIER, MD | Contact (sur clinicalTrials) | |||
| CHU Besançon - Hopital Jean Mijoz - 25000 - Besançon - France | Tristan MAURINA, MD | Contact (sur clinicalTrials) | |||
| CHU de la Martinique - Hôpital Albert Clarac - 97200 - Fort-de-France - France | Mylène ANNONAY, MD | Contact (sur clinicalTrials) | |||
| CHU de Poitiers - Pôle Régional de Cancérologie - 86021 - Poitiers - France | Sheik EMAMBUX, MD | Contact (sur clinicalTrials) | |||
| CHU Grenoble - 38043 - Grenoble - France | Mathieu LARAMAS, MD | Contact (sur clinicalTrials) | |||
| CHU le MANS - 72000 - Le Mans - France | Benoît SEUWIN, MD | Contact (sur clinicalTrials) | |||
| CHU Nîmes - 30029 - Nîmes - France | Nadine HOUEDE, MD | Contact (sur clinicalTrials) | |||
| CHU Saint-Etienne - 42055 - Saint-Étienne - France | Pierre Cornillon, MD | Contact (sur clinicalTrials) | |||
| Clinique Pasteur - 29200 - Brest - France | Ali HASBINI, MD | Contact (sur clinicalTrials) | |||
| Clinique Pasteur ONCORAD - 31076 - Toulouse - France | Igor LATORZEFF, MD | Contact (sur clinicalTrials) | |||
| Clinique Sainte Anne - Strasbourg Oncologie Libérale - 67000 - Strasbourg - France | Louis-Marie DOURTHE, MD | Contact (sur clinicalTrials) | |||
| Groupe Hospitalier Bretagne Sud - 56322 - Lorient - France | Marie L'Huissier, MD | Contact (sur clinicalTrials) | |||
| Hôpital Privé de la Loire - 42100 - Saint-Étienne - France | Aline GUILLOT, MD | Contact (sur clinicalTrials) | |||
| Hôpital Saint Louis - 75475 - Paris - France | Hélène GAUTHIER, MD | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon -Lyon Sud - 69310 - Pierre-Bénite - France | Sophie TARTAS, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Lorraine - 54500 - Vandœuvre-lès-Nancy - France | Vincent MASSARD, MD | Contact (sur clinicalTrials) | |||
| Institut de cancérologie Strasbourg Europe - 67200 - Strasbourg - France | Sophie MARTIN, MD | Contact (sur clinicalTrials) | |||
| Institut Jean Godinot - 51056 - Reims - France | Jean-Christophe EYMARD, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - 13273 - Marseille - France | Gwenaelle GRAVIS, MD | Contact (sur clinicalTrials) | |||
| Institut Sainte Catherine - 84918 - Avignon - France | Werner HILGERS, MD | Contact (sur clinicalTrials) | |||
| IUCT Oncopole - 31059 - Toulouse - France | Loic MOUREY, MD | Contact (sur clinicalTrials) | |||
| Polyclinique de Limoges - 87000 - Limoges - France | Sabrina FALKOWSKI, MD | Contact (sur clinicalTrials) | |||
Critères
Homme
Inclusion Criteria:
1. Signed a written informed consent form prior to any trial specific procedures.
2. Men with histologically or cytologically confirmed adenocarcinoma of the prostate.
3. Aged ≥18 years old at the time of signing informed consent.
4. De novo metastatic disease defined by clinical or radiological evidence of
metastases.
Note: For patients with nodal metastases only, only patients with extra-pelvic
enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be
included if they have either:
- At least one extra-pelvic lymph node ≥2 cm
- At least one extra-pelvic lymph node ≥1 cm if the patients also have at least
one pelvic lymph node ≥2 cm
5. Measurable disease or bone lesions that are evaluable according to PCWG3 criteria.
6. Ineligible for treatment with all of the following drugs: docetaxel, abiraterone,
enzalutamide, apalutamide; AND meets at least one of the following frailty criteria:
1. Activities of daily living (ADL) assessment (excluding urinary incontinence
question) score 3 or 4/5, or;
2. 4-Instrumental activities of daily living (4-IADL) assessment score 2 or 3/4,
or;
3. A Grade 3 event on the Cumulative Illness Score Rating-Geriatrics (CISR-G)
questionnaire, or;
4. Body mass index (BMI) ≤21 kg/m² and/or >5% weight loss in the last 6 months,
or;
5. Timed up and go test (TUG) >14 sec. Nota Bene: Regarding CISR-G assessment,
more specifically genitourinary scoring, score N°4 is not applicable.
7. Adequate bone marrow function: haemoglobin ≥80 g/L, white blood cells ≥3.0 x10⁹/L
and platelets ≥80 x10⁹/L.
8. Adequate liver function: alanine aminotransferase (ALT) <2 x upper limit of normal
(ULN) and bilirubin <1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must
have a normal conjugated bilirubin). For patients with documented liver metastasis,
ALT <5 x ULN is acceptable.
9. Adequate renal function: calculated creatinine clearance >30 ml/min (using the
Modification of Diet in Renal Disease [MDRD] or Chronic Kidney Disease Epidemiology
Collaboration [CKD EPI) method).
10. For sexually active men, agreement to use adequate contraception for the duration of
trial participation and up to 2 weeks after completing study treatment.
11. Affiliated to the social security system or in possession of equivalent private
health insurance (according to local regulations for participation in clinical
trials).
12. Willing and able to comply with the protocol for the duration of the trial including
undergoing treatment and scheduled visits, and examinations including follow-up.
1. Signed a written informed consent form prior to any trial specific procedures.
2. Men with histologically or cytologically confirmed adenocarcinoma of the prostate.
3. Aged ≥18 years old at the time of signing informed consent.
4. De novo metastatic disease defined by clinical or radiological evidence of
metastases.
Note: For patients with nodal metastases only, only patients with extra-pelvic
enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be
included if they have either:
- At least one extra-pelvic lymph node ≥2 cm
- At least one extra-pelvic lymph node ≥1 cm if the patients also have at least
one pelvic lymph node ≥2 cm
5. Measurable disease or bone lesions that are evaluable according to PCWG3 criteria.
6. Ineligible for treatment with all of the following drugs: docetaxel, abiraterone,
enzalutamide, apalutamide; AND meets at least one of the following frailty criteria:
1. Activities of daily living (ADL) assessment (excluding urinary incontinence
question) score 3 or 4/5, or;
2. 4-Instrumental activities of daily living (4-IADL) assessment score 2 or 3/4,
or;
3. A Grade 3 event on the Cumulative Illness Score Rating-Geriatrics (CISR-G)
questionnaire, or;
4. Body mass index (BMI) ≤21 kg/m² and/or >5% weight loss in the last 6 months,
or;
5. Timed up and go test (TUG) >14 sec. Nota Bene: Regarding CISR-G assessment,
more specifically genitourinary scoring, score N°4 is not applicable.
7. Adequate bone marrow function: haemoglobin ≥80 g/L, white blood cells ≥3.0 x10⁹/L
and platelets ≥80 x10⁹/L.
8. Adequate liver function: alanine aminotransferase (ALT) <2 x upper limit of normal
(ULN) and bilirubin <1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must
have a normal conjugated bilirubin). For patients with documented liver metastasis,
ALT <5 x ULN is acceptable.
9. Adequate renal function: calculated creatinine clearance >30 ml/min (using the
Modification of Diet in Renal Disease [MDRD] or Chronic Kidney Disease Epidemiology
Collaboration [CKD EPI) method).
10. For sexually active men, agreement to use adequate contraception for the duration of
trial participation and up to 2 weeks after completing study treatment.
11. Affiliated to the social security system or in possession of equivalent private
health insurance (according to local regulations for participation in clinical
trials).
12. Willing and able to comply with the protocol for the duration of the trial including
undergoing treatment and scheduled visits, and examinations including follow-up.
1. Three or more Grade 3, or any Grade 4 events on the CISR-G questionnaire. Nota Bene:
(Regarding CISR-G assessment, more specifically genitourinary scoring, score N°4 is
not applicable).
2. Eastern Cooperative Oncology Group (ECOG) performance status score ≥3.
3. Hypertension not controlled by an anti-hypertensive treatment (systolic blood
pressure [BP] ≥160 mmHg or diastolic BP ≥95 mmHg; 3 consecutive measures taken 5
minutes apart).
4. Acute toxicities of prior treatments and procedures not resolved to grade ≤1 or
baseline before randomisation, with the exception of hot flushes and erectile
dysfunction.
5. Previous systemic treatment for prostate cancer, except less than 12 weeks of ADT
and/or an old-generation AR inhibitor.
6. Severe or uncontrolled concurrent disease, infection or co-morbidity.
7. Known hypersensitivity to the study treatment or any of its ingredients.
8. Major surgery within 28 days before randomisation.
9. Any of the following within 6 months before randomisation: stroke, myocardial
infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass
graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.
10. Prior malignancy ≤3 years before study enrolment. Adequately treated basal cell or
squamous cell carcinoma of skin or superficial bladder cancer that has not spread
behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as
any localized cancer for which treatment has been completed ≥6 months before
randomisation and from which the subject has been disease-free, or for which the
risk of relapse is less than 30%, as well as early stage chronic lymphocytic
leukaemia that does not require any specific treatment.
11. Inability to swallow oral medications.
12. Gastrointestinal disorder or procedure that can be expected to interfere
significantly with the absorption of study treatment.
13. Known to have active viral hepatitis, active human immunodeficiency virus (HIV) or
chronic liver disease at screening.
14. Treatment with any investigational product within 28 days before randomisation.
15. Concurrent participation in another clinical trial involving an investigational
product (patients enrolled in non-experimental trials with no modification of the
standard of care can be included).
16. Individual deprived of liberty or placed under the authority of a tutor.
17. 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
that, in the opinion of the investigator, would preclude participation in this
trial.