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

Who is this study for? Patients with Prostate Cancer Metastatic
What treatments are being studied? Androgen Deprivation Therapy
Status: Recruiting
Location: See all (90) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Signed a written informed consent form prior to any trial specific procedures.

• Men with histologically or cytologically confirmed adenocarcinoma of the prostate.

• Aged ≥18 years old at the time of signing informed consent.

• 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

• Measurable disease or bone lesions that are evaluable according to PCWG3 criteria.

• Ineligible for treatment with all of the following drugs: docetaxel, abiraterone, enzalutamide, apalutamide; AND meets at least one of the following frailty criteria:

∙ Activities of daily living (ADL) assessment (excluding urinary incontinence question) score 3 or 4/5, or;

‣ 4-Instrumental activities of daily living (4-IADL) assessment score 2 or 3/4, or;

‣ A Grade 3 event on the Cumulative Illness Score Rating-Geriatrics (CISR-G) questionnaire, or;

‣ Body mass index (BMI) ≤21 kg/m² and/or \>5% weight loss in the last 6 months, or;

‣ Timed up and go test (TUG) \>14 sec. Nota Bene: Regarding CISR-G assessment, more specifically genitourinary scoring, score N°4 is not applicable.

• Adequate bone marrow function: haemoglobin ≥80 g/L, white blood cells ≥3.0 x10⁹/L and platelets ≥80 x10⁹/L.

• 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.

• 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).

⁃ For sexually active men, agreement to use adequate contraception for the duration of trial participation and up to 2 weeks after completing study treatment.

⁃ Affiliated to the social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials).

⁃ 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.

Locations
Other Locations
Belgium
Grand Hopital de Charleroi - site Notre Dame
RECRUITING
Charleroi
Groupe Jolimont - Hôpital De Jolimont
RECRUITING
Haine-saint-paul
CHU UCL NAMUR - Site STE. ELISABETH
RECRUITING
Namur
Clinique Saint Pierre
RECRUITING
Ottignies
France
Institut Sainte Catherine
RECRUITING
Avignon
Centre Hospitalier Cote basque
RECRUITING
Bayonne
CHU Besançon - Hopital Jean Mijoz
RECRUITING
Besançon
Centre Institut Bergonié
RECRUITING
Bordeaux
Clinique Pasteur
RECRUITING
Brest
Centre François Baclesse
RECRUITING
Caen
Centre Hospitalier Métropole Savoie
RECRUITING
Chambéry
Centre Jean Perrin
RECRUITING
Clermont-ferrand
APHP - Hôpital Henri Mondor
RECRUITING
Créteil
Centre Georges François Leclerc
RECRUITING
Dijon
CHU de la Martinique - Hôpital Albert Clarac
NOT_YET_RECRUITING
Fort-de-france
CHU Grenoble
RECRUITING
Grenoble
Centre CHV Vendée
RECRUITING
La Roche-sur-yon
CHU le MANS
RECRUITING
Le Mans
Centre Oscar Lambret
RECRUITING
Lille
Polyclinique de Limoges
RECRUITING
Limoges
Groupe Hospitalier Bretagne Sud
RECRUITING
Lorient
Centre Léon Bérard
RECRUITING
Lyon
Institut Paoli-Calmettes
RECRUITING
Marseille
Centre Azuréen de Cancérologie
RECRUITING
Mougins
Centre Antoine Lacassagne
RECRUITING
Nice
CHU Nîmes
RECRUITING
Nîmes
Centre Groupe Hospitalier Diaconesses Croix Saint-Simon
RECRUITING
Paris
Hôpital Européen Georges Pompidou
RECRUITING
Paris
Hôpital Saint Louis
RECRUITING
Paris
Hôpital Tenon
RECRUITING
Paris
Hospices Civils de Lyon -Lyon Sud
RECRUITING
Pierre-bénite
CHU de Poitiers - Pôle Régional de Cancérologie
RECRUITING
Poitiers
CH Annecy Genevois
RECRUITING
Pringy
CHIC Quimper
RECRUITING
Quimper
Institut Jean Godinot
RECRUITING
Reims
Centre Eugène Marquis
RECRUITING
Rennes
Centre Hospitalier Rodez
RECRUITING
Rodez
CHU Saint-Etienne
RECRUITING
Saint-etienne
Hôpital Privé de la Loire
RECRUITING
Saint-etienne
CHP Centre Saint Grégoire
RECRUITING
Saint-grégoire
Hôpital Instruction des Armées - BEGIN
RECRUITING
Saint-mandé
Clinique Sainte Anne - Strasbourg Oncologie Libérale
RECRUITING
Strasbourg
Institut de cancérologie Strasbourg Europe
RECRUITING
Strasbourg
Hôpital FOCH
RECRUITING
Suresnes
Centre Hospitalier Intercommunal de Toulon-La Seyne - Hôpital Ste Musse
RECRUITING
Toulon
Clinique Pasteur ONCORAD
RECRUITING
Toulouse
IUCT Oncopole
RECRUITING
Toulouse
CHRU de Tours -Hôpital Bretonneau
RECRUITING
Tours
Institut de Cancérologie de Lorraine
RECRUITING
Vandœuvre-lès-nancy
Gustave Roussy Center
RECRUITING
Villejuif
Germany
Universitätsmedizin Essen Hufelandstraße
NOT_YET_RECRUITING
Essen
University cancer center Hamburg-Eppendorf Martinistraße
NOT_YET_RECRUITING
Hamburg
Universitätsklinikum Münster Klinik für Urologie und Kinderurologie Albert-Schweitzer-Campus 1 Gebäude A1
NOT_YET_RECRUITING
Münster
Ireland
Mater Misericordiae University Hospital
RECRUITING
Dublin
Mater Private Hospital
RECRUITING
Dublin
St Vincent's University Hospital
RECRUITING
Dublin
Tallaght university Hospital
RECRUITING
Dublin
Italy
University of Bari, Policlinico
NOT_YET_RECRUITING
Bari
FPO IRCCS Candiolo Turin
NOT_YET_RECRUITING
Candiolo
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
RECRUITING
Meldola
Fondazione IRCSS Istituto Nazionale Tumori
NOT_YET_RECRUITING
Milan
istituto tumori Fondazione G.Pascale
NOT_YET_RECRUITING
Napoli
Azienda Ospedaliera S. Camillo-Forlanini
NOT_YET_RECRUITING
Roma
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NOT_YET_RECRUITING
Roma
Istituto Clinico Humanitas - IRCCS
RECRUITING
Rozzano
UOC Oncologia Medica
NOT_YET_RECRUITING
Syracuse
Santa Chiara Hospital
RECRUITING
Trento
Netherlands
Albert Schweizer Hospital
NOT_YET_RECRUITING
Dordrecht
Radboudumc - Dutch Uro-Oncology Study Group (DUOS)
RECRUITING
Nijmegen
Romania
Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti
NOT_YET_RECRUITING
Bucharest
Amethyst Radiotherapy Center Cluj SRL
NOT_YET_RECRUITING
Cluj-napoca
Institul Oncologic Cluj-Napoca
RECRUITING
Cluj-napoca
OncoHelp Hospital
RECRUITING
Timișoara
Slovakia
Narodny Onkologicky Institut
NOT_YET_RECRUITING
Bratislava
Spain
Institut Catala d'Oncologia, Badalona-Hospital Germans Trias i Pujol
RECRUITING
Badalona
Hospital Clinic
RECRUITING
Barcelona
Hospital del Mar
RECRUITING
Barcelona
Vall d'Hebron Institute of Oncology. Vall d'Hebron University Hospital
RECRUITING
Barcelona
Institut Català d'Oncologia de Girona
RECRUITING
Girona
Centro Integral Oncologico HM Clara Campal
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
NOT_YET_RECRUITING
Madrid
Althaia, Xara Assistencial Universitaria Mansera
RECRUITING
Manresa
Fundacion Instituto Valenciano De Oncologia
RECRUITING
Valencia
Sweden
Sahlgrenska University Hospital
NOT_YET_RECRUITING
Gothenburg
Skane University Hospital
NOT_YET_RECRUITING
Malmo
Switzerland
Istituto Oncologico della Svizzera Italiana (IOSI) - Ospedale S.Giovanni
RECRUITING
Bellinzona
Kantonsspital Graubünden, Onkologie/ Hämatologie
RECRUITING
Chur
Cantonal Hospital St.Gallen
RECRUITING
Sankt Gallen
Istituto Oncologico della Svizzera Italiana (IOSI) - Ospedale Italiano di Lugano
RECRUITING
Viganello
Universitätsspital Zürich - Onkologie
RECRUITING
Zurich
Contact Information
Primary
Catherine N LEGER
c-leger@unicancer.fr
+33 (0) 1 85 34 31 13
Backup
Rachida KHERRAZ
r-kherraz@unicancer.fr
+33 (0) 1 80 50 15 99
Time Frame
Start Date: 2022-04-19
Estimated Completion Date: 2037-09
Participants
Target number of participants: 300
Treatments
Experimental: ADT + darolutamide
ADT + darolutamide 600 mg po bid
Placebo_comparator: ADT + placebo
ADT + placebo po bid
Related Therapeutic Areas
Sponsors
Collaborators: Bayer
Leads: UNICANCER

This content was sourced from clinicaltrials.gov

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