Prostate Cancer MetastaticPhase 3GETUG-AFU 40NCT04916613
ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)
A Phase 3 study testing Darolutamide 300 mg and Androgen deprivation therapy in people with Prostate Cancer Metastatic, run by UNICANCER at 95 sites in 12 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- Darolutamide 300 mg and Androgen deprivation therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 95 sitesin 12 countries
- Study dates
- 19 Apr 2022to Sep 2037
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
- Eastern Cooperative Oncology Group (ECOG) performance status score ≥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).
- 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.
- Previous systemic treatment for prostate cancer, except less than 12 weeks of ADT and/or an old-generation AR inhibitor.
- Severe or uncontrolled concurrent disease, infection or co-morbidity.
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- Known hypersensitivity to the study treatment or any of its ingredients.
- Major surgery within 28 days before randomisation.
- 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.
- 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.
- Inability to swallow oral medications.
- Gastrointestinal disorder or procedure that can be expected to interfere significantly with the absorption of study treatment.
- Known to have active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease at screening.
- Treatment with any investigational product within 28 days before randomisation.
- 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).
- Individual deprived of liberty or placed under the authority of a tutor.
- 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.
Trial locations and contacts
95 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
95 sites in 12 countries
France50 sites, 50 recruiting
- Recruiting
Institut Sainte Catherine
Avignon, 84918
Hachmi AIT MOHAND SAID, MD, +33(0)4 90 27 62 74, h.aitmohandsaid@isc84.org
- Recruiting
Centre Hospitalier Cote basque
Bayonne, 64109
Louis FRANCOIS, MD, +33(0)6 78 57 62 05, lfrancois@ch-cotebasque.fr
- Recruiting
CHU Besançon - Hopital Jean Mijoz
Besançon, 25000
Tristan MAURINA, MD, +33(0)3 70 63 24 03, t1maurina@chu-besancon.fr
- Recruiting
Centre Pierre Curie
Beuvry, 62660
Aurelie FADIN, MD, 03 21 61 92 84, aurelie.fadin@ichf.fr
- Recruiting
Centre Institut Bergonié
Bordeaux, 22076
Guihem ROUBAUD, MD, +33(0)5 56 33 33 33, g.roubaud@bordeaux.unicancer.fr
- Recruiting
Clinique Pasteur
Brest, 29200
Ali HASBINI, MD, 02.98.31.32.00, alihasbini@oncologie-brest.fr
- Recruiting
Centre François Baclesse
Caen, 14076
Florence JOLY, MD, +33(0)2 31 45 50 50, f.joly@baclesse.unicancer.fr
- Recruiting
Centre Hospitalier Métropole Savoie
Chambéry, 73000
Mélanie TADJ LESAGE, MD, +33(0)4 79 96 61 81, melanie.tadj-lesage@ch-metropole-savoie.fr
- Recruiting
Centre Jean Perrin
Clermont-Ferrand, 63011
Hakim MAHAMMEDI, MD, +33(0)4 73 27 81 31, hakim.mahammedi@clermont.unicancer.fr
- Recruiting
CH Colmar
Colmar
Jonathan THOUVENIN, MD, 0389124471, jonathan.thouvenin@ch-colmar.fr
- Recruiting
APHP - Hôpital Henri Mondor
Créteil, 94010
Christophe TOURNIGAND, +33(0)1 49 81 25 67, christophe.tournigand@aphp.fr
- Recruiting
Centre Georges François Leclerc
Dijon, 21079
Sylvain LADOIRE, MD, +33(0)3 80 73 75 06, sladoire@cgfl.fr
- Recruiting
CHU Grenoble
Grenoble, 38043
Mathieu LARAMAS, MD, +33(0)4 76 76 54 51, mlaramas@chu-grenoble.fr
- Not yet recruiting
CHU Sud Réunion
La Réunion, 97448
Jean-Francois DELATTRE, MD, +262 (0)262359000, auguste.delattre@chu-reunion.fr
- Recruiting
Centre CHV Vendée
La Roche-sur-Yon, 85925
Charlotte GREILSAMER, MD, +33(0)2 51 44 61 73, charlotte.greilsamer@ght85.fr
- Recruiting
CHU le MANS
Le Mans, 72000
Benoît SEUWIN, MD, +33(0)2 43 43 43 32, bseuwin@ch-lemans.fr
- Recruiting
Centre Oscar Lambret
Lille, 59000
Aurélien CARNOT, MD, +33(0)3 20 29 59 59, a-carnot@o-lambret.fr
- Recruiting
Polyclinique de Limoges
Limoges, 87000
Sabrina FALKOWSKI, MD, +33(0)555454800, sf@imagemed-87.com
- Recruiting
Groupe Hospitalier Bretagne Sud
Lorient, 56322
Marie L'Huissier, MD, +33(0)2 97 06 94 22, m.lhuissier@ghbs.bzh
- Recruiting
Centre Léon Bérard
Lyon, 69373
Aude FLECHON, MD, +33(0)4 78 78 26 43, aude.flechon@lyon.unicancer.fr
- Recruiting
Institut Paoli-Calmettes
Marseille, 13273
Gwenaelle GRAVIS, MD, +33(0)4 91 22 37 40, gravisg@ipc.unicancer.fr
- Recruiting
CH Mont De Marsan
Mont-de-Marsan, 40024
Sylvestre LE MOULEC, MD, 0558051725, sylvestre.le-moulec@ch-mdm.fr
- Recruiting
Centre Azuréen de Cancérologie
Mougins, 06250
Philippe Ronchin, MD, 04 92 92 37 37, ronchinp@yahoo.fr
- Recruiting
Centre Antoine Lacassagne
Nice, 06189
Delphine BORCHIELLINI, MD, +33(0)4 92 03 17 94, delphine.borchiellini@nice.unicancer.fr
- Recruiting
CHU Nîmes
Nîmes, 30029
Nadine HOUEDE, MD, +33(0)4 66 68 33 01, nadine.houede@chu-nimes.fr
- Recruiting
Centre Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, 75020
Camille SERRATE, MD, +33(0)6 73 43 57 65, cserrate@hopital-dcss.org
- Recruiting
Hôpital Saint Louis
Paris, 75475
Hélène GAUTHIER, MD, +33(0)1 42 49 98 96, helene.gauthier@aphp.fr
- Recruiting
Hôpital Européen Georges Pompidou
Paris, 75908
Stéphane OUDARD, MD, +33(0)1 56 09 54 25, stephane.oudard@aphp.fr
- Recruiting
Hôpital Tenon
Paris, 75970
Ahmed KHALIL, MD, +33(0)1 56 01 61 43, ahmed.khalil@aphp.fr
- Recruiting
Hospices Civils de Lyon -Lyon Sud
Pierre-Bénite, 69310
Sophie TARTAS, MD, +33(0)4 78 86 43 24, sophie.tartas@chu-lyon.fr
- Recruiting
CHU de Poitiers - Pôle Régional de Cancérologie
Poitiers, 86021
Sheik EMAMBUX, MD, +33(0)5 49 44 44 44, sheik.emambux@chu-poitiers.fr
- Recruiting
CH Annecy Genevois
Pringy, 74374
Mélodie CARBONNAUX, MD, +33(0)4 50 58 52 55, mcarbonnaux@ch-annecygenevois.fr
- Recruiting
CHIC Quimper
Quimper, 29107
Josselin ANNIC, MD, +33(0)2 98 52 65 79, josselin.annic@ch-cornouille.fr
- Recruiting
Institut Jean Godinot
Reims, 51056
Jean-Christophe EYMARD, MD, +33(0)3 26 50 43 82, jeanchristophe.eymard@reims.unicancer.fr
- Recruiting
Centre Eugène Marquis
Rennes, 35042
Laurence Crouzet, MD, 02.99.25.29.66, l.crouzet@rennes.unicancer.fr
- Recruiting
Centre Eugène Marquis - Rennes
Rennes
Laurence CROUZET, MD, 02.99.25.29.66, l.crouzet@rennes.unicancer.fr
- Recruiting
Centre Hospitalier Rodez
Rodez, 12027
Guillermo REYES-ORTEGA, MD, +33(0)5 65 55 22 40, g.reyes-ortega@ch-rodez.fr
- Recruiting
CHU Saint-Etienne
Saint-Etienne, 42055
Pierre Cornillon, MD, 04 77 91 70 25, pierre.cornillon@chu-st-etienne.fr
- Recruiting
Hôpital Privé de la Loire
Saint-Etienne, 42100
Aline GUILLOT, MD, +33 (0)4 77 42 29 56, Aline.GUILLOT@ramsaysante.fr
- Recruiting
CHP Centre Saint Grégoire
Saint-Grégoire, 35760
Xavier ARTIGNAN, MD, +33(0)2 90 09 44 64, xartignan@vivalto-sante.com
- Recruiting
Hôpital Instruction des Armées - BEGIN
Saint-Mandé, 94160
Hugo PICCHI, MD, +33(0)1 86 93 75 20, picchi.hugo90@gmail.com
- Recruiting
Clinique Sainte Anne - Strasbourg Oncologie Libérale
Strasbourg, 67000
Louis-Marie DOURTHE, MD, +33(0)3 88 45 37 50, lm.dourthe@solcrr.org
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67200
Philippe BARTHELEMY, MD, +33(0)3 68 76 67 67, philippe.barthelemy@chru-strasbourg.fr
- Recruiting
Hôpital FOCH
Suresnes, 92151
Raffaele RATTA, MD, +33(0)1 46 25 24 10, r.ratta@hopital-foch.com
- Recruiting
Centre Hospitalier Intercommunal de Toulon-La Seyne - Hôpital Ste Musse
Toulon, 83056
Xavier TCHIKNAVORIAN, MD, +33(0)4 94 14 46 11, Xavier.Tchiknavorian@ch-toulon.fr
- Recruiting
IUCT Oncopole
Toulouse, 31059
Loic MOUREY, MD, +33(0)5 31 15 58 11, mourey.loic@iuct-oncopole.fr
- Recruiting
Clinique Pasteur ONCORAD
Toulouse, 31076
Igor LATORZEFF, MD, i.latorzeff@clinique-pasteur.com
- Recruiting
CHRU de Tours -Hôpital Bretonneau
Tours, 37044
Mathilde CANCEL, MD, +33(0)2 47 47 99 19, m.cancel@chu-tours.fr
- Recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54500
Vincent MASSARD, MD, +33(0)3 83 59 84 00, v.massard@nancy.unicancer.fr
- Recruiting
Gustave Roussy Center
Villejuif, 94805
Karim FIZAZI, MD, +33 (0)1 42 11 43 17, karim.fizazi@gustaveroussy.fr
Italy11 sites, 9 recruiting
- Suspended
University of Bari, Policlinico
Bari, 70124
- Recruiting
FPO IRCCS Candiolo Turin
Candiolo
ALESSANDRA MOSCA, MD, +30 0119933250, alessandra.mosca@ircc.it
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Riuniti Di Foggia
Foggia
VINCENZA CONTEDUCA, MD, +39 0881 736389, vincenza.conteduca@unifg.it
- Recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola, 47014
NICOLE BRIGHI, MD, +390543739100, ugo.degiorgi@irst.emr.it
- Recruiting
Fondazione IRCSS Istituto Nazionale Tumori
Milan, 20133
ELENA VERZONI, MD, +390223904449, elena.Verzoni@istitutotumori.mi.it
- Recruiting
IRCCS Ospedale San Raffaele
Milan
Andrea NECCHI, MD, +39 02 2643 5789, necchi.andrea@hsr.it
- Recruiting
istituto tumori Fondazione "G.Pascale"
Naples, 80131
SABRINA ROSSETTI, MD, +39 0815903861, s.rossetti@istitutotumori.na.it
- Suspended
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
- Recruiting
Istituto Clinico Humanitas - IRCCS
Rozzano, 20089
PAOLO ANDREA ZUCALI, MD, +39 0282244061, Paolo.zucali@hunimed.eu
- Recruiting
UOC Oncologia Medica
Syracuse, 96100
PAOLO TRALONGO, MD, +39 0931724464, paolo.tralongo@asp.sr.it
- Recruiting
Santa Chiara Hospital
Trento, 38122
Orazio CAFFO, MD, +390461904416, orazio.caffo@apss.tn.it
Spain9 sites, 9 recruiting
- Recruiting
Institut Catala d'Oncologia, Badalona-Hospital Germans Trias i Pujol
Badalona
Albert FONT, MD, afont@iconcologia.net
- Recruiting
Hospital Clinic
Barcelona
Begona MELLADO, MD, BMELLADO@clinic.cat
- Recruiting
Hospital del Mar
Barcelona
Alejo RODRIGUEZ VIDAL, MD, arodriguezvida@hospitaldelmar.cat
- Recruiting
Vall d'Hebron Institute of Oncology. Vall d'Hebron University Hospital
Barcelona
David Marmolejo, MD, davidmarmolejo@vhio.net
- Recruiting
Institut Català d'Oncologia de Girona
Girona
Nuria SALA, MD, nsala@iconcologia.net
- Recruiting
Centro Integral Oncologico HM Clara Campal
Madrid
Juan Francisco RODRIGUEZ MORENO, MD, jfrodriguez@hmhospitales.com
- Recruiting
Hospital Universitario 12 de Octubre
Madrid
Daniel CASTELLANO, MD, cdanicas@hotmail.com
- Recruiting
Althaia, Xara Assistencial Universitaria Mansera
Manresa
Mariona FIGOLS, MD, mfigols@althaia.cat
- Recruiting
Fundacion Instituto Valenciano De Oncologia
Valencia
Manel Beamud Cortes, MD, mbeamud@fivo.org
Ireland5 sites, 5 recruiting
- Recruiting
St Vincent's University Hospital
Dublin, D04 T6F4
Ray MCDERMOTT, MD, Ray.McDermott@tuh.ie
- Recruiting
Tallaght university Hospital
Dublin, D24 NR0A
Ray MCDERMOTT, MD, Ray.McDermott@tuh.ie
- Recruiting
Mater Misericordiae University Hospital
Dublin
John McCAFFREY, MD, jmccaffrey@mater.ie
- Recruiting
Mater Private Hospital
Dublin
John McCAFFREY, MD, jmccaffrey@mater.ie
- Recruiting
University Hospital Limerick
Limerick
Grzegorz Korpanty, MD, + 35361588241, greg.korpanty2@hse.ie
Switzerland5 sites, 5 recruiting
- Recruiting
Istituto Oncologico della Svizzera Italiana (IOSI) - Ospedale S.Giovanni
Bellinzona, 6500
Silke GILLESSEN SOMMER, MD, +41(0)91 811 95 43, Silke.GillessenSommer@eoc.ch
- Recruiting
Kantonsspital Graubünden, Onkologie/ Hämatologie
Chur
Richard CATHOMAS, MD, richard.cathomas@ksgr.ch
- Recruiting
Cantonal Hospital St.Gallen
Sankt Gallen
Stéfanie FISCHER, MD, Fischer Stefanie HCARE-KSSG-ONKO <Stefanie.Fischer@kssg.ch>
- Recruiting
Istituto Oncologico della Svizzera Italiana (IOSI) - Ospedale Italiano di Lugano
Viganello
Silke GILLESSEN SOMMER, silke.gillessen@eoc.ch
- Recruiting
Universitätsspital Zürich - Onkologie
Zurich
Anja LORCH, MD, Anja.Lorch@usz.ch
Belgium4 sites, 4 recruiting
- Recruiting
Grand Hopital de Charleroi - site Notre Dame
Charleroi, 6000
Marco GIZZI, MD, +32 71 10 47 16, marco.gizzi@ghdc.be
- Recruiting
Groupe Jolimont - Hôpital De Jolimont
Haine-Saint-Paul, 7100
Emmanuel SERONT, MD, +32 642 341 66, Emmanuel.SERONT@jolimont.be
- Recruiting
CHU UCL NAMUR - Site STE. ELISABETH
Namur, 5000
Vincent VANHAUDENARDE, MD, +32 81 72 05 47, vincent.vanhaudenarde@uclouvain.be
- Recruiting
Clinique Saint Pierre
Ottignies, 1340
Nicolas WHENHAM, MD, +32 10 43 72 41, nicolas.whenham@cspo.be
Romania4 sites, 4 recruiting
- Not yet recruiting
Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti
Bucharest
Laurentia GALES, laurentia.gales@yahoo.com
- Not yet recruiting
Amethyst Radiotherapy Center Cluj SRL
Cluj-Napoca
Cristina Ligia CEBOTARU, cristinacebotaru@yahoo.com
- Recruiting
Institul Oncologic Cluj-Napoca
Cluj-Napoca
Gabriel KACSO, Prof, gabi.kacso@gmail.com
- Recruiting
OncoHelp Hospital
Timișoara
Serban NEGRU, snegru@yahoo.com
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Albert Schweizer Hospital
Dordrecht
Joan VANDEN BOSCH, Prof, j.vandenbosch@asz.nl
- Recruiting
Radboudumc - Dutch Uro-Oncology Study Group (DUOS)
Nijmegen
Niven MEHRA, Dr, Niven.Mehra@radboudumc.nl
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
Johan STRANNE, johan.stranne@vgregion.se
- Recruiting
Skane University Hospital
Malmö
Anders BJARTELL, anders.bjartell@med.lu.se
Martinique1 site, 1 recruiting
- Not yet recruiting
CHU de la Martinique - Hôpital Albert Clarac
Fort-de-France, 97200
Mylène ANNONAY, MD, MYLENE.ANNONAY@chu-martinique.fr
Slovakia1 site, 1 recruiting
- Recruiting
Narodny Onkologicky Institut
Bratislava
Michal MEGO, michal.mego@nou.sk
About this study
Official title: 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
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.
Read the detailed description
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. The study plans to enroll 300 patients who will be randomized (1:1) to receive either: (i) Experimental arm: ADT + darolutamide 600 mg po bid, or (ii) Control arm: ADT + placebo po bid. Response to treatment will be assessed according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria (Scher, 2016). Treatment will be continued until radiographic disease progression. Treatment may also be terminated at the initiative of either the patient or the investigator for any reason that would be beneficial to the patient, including: unacceptable toxicity, intercurrent conditions that preclude continuation of treatment, or patient request. Following treatment discontinuation patients will enter the follow-up period and will be monitored for up to 10 years with regards to survival status, subsequent antineoplastic treatments and the status of ongoing adverse events (AEs) and/or new investigational product related AEs.
- Conditions
- Prostate Cancer Metastatic
- Being tested
- Darolutamide 300 mg, Placebo, Androgen deprivation therapy
- Keywords
- PEACE 6 -Vulnerable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darolutamide 300 mgDrug
Also called Nubeqa®
600 mg po, b.i.d.
PlaceboDrug
po, b.i.d.
Androgen deprivation therapyDrug
Also called ADT
Use according to local standard of care
| Study group | Role | What they receive |
|---|---|---|
| ADT + darolutamide | Experimental | ADT + darolutamide 600 mg po bid Receives: Drug: Darolutamide 300 mg; Drug: Androgen deprivation therapy |
| ADT + placebo | Placebo comparator | ADT + placebo po bid Receives: Drug: Placebo; Drug: Androgen deprivation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic progression-free survival
Time from randomisation to radiographic progression according to the Prostate Cancer Working Group 3 (PCWG3) criteria or death, whichever occurs first
Measured: From randomisation to radiographic progression or death, up to 18 months
Secondary outcomes (17)
Castration-resistant prostate cancer-free survival
Time from randomisation to onset of castrate resistant prostate cancer (CRPC) according to PCWG3 criteria, or death, whichever occurs first
Measured: From randomisation to onset of CRPC or death, up to 18 months
Clinical progression-free survival
Time from randomisation to first occurrence of any one of the following:
(i) Cancer pain deterioration (2-point deterioration from baseline according to the Brief Pain Inventory - Short Form [BPI-SF] questionnaire; initiation of opioid therapy, or a ≥30% increase in opiate use) (ii) Any deterioration of physical function measured using the 4-IADL assessment tools (Lawton, 1969) (iii) A deterioration in ECOG performance status of at least 2 points from baseline (iv) Death from any cause.
Measured: From randomisation to clinical progression or death, up to 18 months
Overall survival
Time from randomisation to the time of death from any cause
Measured: From randomization to death from any cause, up to 10 years.
Frequency and severity of adverse events
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders
Measured: From inclusion until 100 days after last dose of investigational product
Time to worsening in prostate cancer-related urinary symptoms
Time from randomisation to first increase from baseline of greater or equal to 8 points in the urinary symptom scale/score (PRURI) measured using the prostate cancer module of the EORTC quality of life questionnaire (EORTC-QLQ-PR25).
This EORTC prostate cancer specific questionnaire is intended to supplement the QLQ-C30. The prostate cancer module is a 25-item questionnaire designed for use among patients with localized and metastatic prostate cancer. It includes subscales assessing urinary symptoms (9 items), bowel symptoms (4 items), treatment-related symptoms (6 items) and sexual functioning (6 items). Using a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), patients indicate the degree to which they have experienced symptoms.
Measured: On treatment day 1 and every 120 days during first years of treatment and every 180 days thereafter if treatment is continued for more than 1 year
Time to next symptomatic skeletal event
Time from randomisation until first occurrence of one of the following: a symptomatic fracture, radiation or surgery to bone or a spinal cord compression
Measured: From randomisation to occurence of a skeletal event, up to 18 months
Complete prostate specific antigen (PSA) response
Defined according to PCWG3 criteria as PSA ≤ 0.2 ng/ml
Measured: At 6 months
Prostate cancer-specific survival
Time from randomisation to the date of death due to prostate cancer (deaths due to other causes will be censored)
Measured: From randomization to death from prostate cancer, up to 10 years.
Time to first subsequent systemic anti-cancer therapy (SACT)
Time from randomisation to the date of initiation of any SACT for CRPC, following initiation of the study treatment
Measured: From randomization up to 10 years.
Second line radiographic progression-free survival
Time from the date of initiation of a second SACT for CRPC to radiographic progression or death, whichever occurs first.
Measured: From randomization up to 10 years.
Second line overall survival
Time from the date of initiation of a second SACT for CRPC to death
Measured: From randomization up to 10 years.
Progression-free survival after next line of treatment (PFS2)
Time from randomisation to second objective disease progression, or death from any cause, whichever first
Measured: From randomization up to 10 years.
Geriatric status
Evaluated using the G-CODE (Paillaud, 2018), a core set of commonly used tools/items for geriatric assessment which has been validated for the collection of geriatric data in clinical cancer trials of older adults, enabling comparison across trials. The tools/items proposed in G-CODE are:
(i) Social assessment: living alone or support requested to stay at home; (ii) Functional autonomy: Activities of Daily Living (ADL) questionnaire and short instrumental ADL questionnaire (4-IADL); (iii) Mobility: Timed Up and Go test; (iv) Nutrition: weight loss during the past 6 months and body mass index; (v) Cognition: Mini-Cog test; (vi) Mood: mini-Geriatric Depression Scale; (vii) Comorbidity: updated Charlson Comorbidity Index.
Measured: At baseline and every 120 days during first years of treatment and every 180 days thereafter if treatment is continued for more than 1 year
Time to deterioration for EORTC QLQ-PR25 symptom subscales
Defined as the first decline in the HRQoL score from baseline equal to or greater than the minimally important difference (MID; a measure of clinical significance) defined as half the standard deviation of the baseline value for each subscale. The prostate cancer module QLQ-PR25 is a 25-item questionnaire designed for use among patients with localized and metastatic prostate cancer. It includes subscales assessing urinary symptoms (9 items), bowel symptoms (4 items), treatment-related symptoms (6 items) and sexual functioning (6 items). Using a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), patients indicate the degree to which they have experienced symptoms.
Measured: On treatment day 1 and every 120 days during first years of treatment and every 180 days thereafter if treatment is continued for more than 1 year
Health related quality of life questionnaire EORTC-QLQ-C30
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: On treatment day 1 and every 120 days during first years of treatment and every 180 days thereafter if treatment is continued for more than 1 year
Health related quality of life questionnaire EORTC-QLQ-PR25
This EORTC prostate cancer specific questionnaire is intended to supplement the QLQ-C30.
The prostate cancer module is a 25-item questionnaire designed for use among patients with localized and metastatic prostate cancer. It includes subscales assessing urinary symptoms (9 items), bowel symptoms (4 items), treatment-related symptoms (6 items) and sexual functioning (6 items). Using a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), patients indicate the degree to which they have experienced symptoms.
Measured: On treatment day 1 and every 120 days during first years of treatment and every 180 days thereafter if treatment is continued for more than 1 year
Health related quality of life questionnaire Brief Pain Inventory - Short Form (BPI-SF)
The Brief Pain Inventory is a self reporting tool to assess the severity of pain and the impact of pain on daily functions in patients with chronically painful diseases or conditions such as cancer, osteoarthritis and low back pain, or with pain from acute conditions such as postoperative pain. The Short Form of the questionnaire (BPI-SF) has been specifically developed for clinical trials.
Measured: On treatment day 1 and every 120 days during first years of treatment and every 180 days thereafter if treatment is continued for more than 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start19 Apr 2022
- Primary completionMar 2028 (estimated)
- Study completionSep 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III, international, multicenter, randomized, double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Karim Fizazi, MD, Principal investigator, Gustave Roussy Cancer Campus, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916613
- Sponsor's protocol ID
- UC-GTG-2006
- Other IDs
- 2022-502425-18-00, 2020-003663-26
- Acronym
- GETUG-AFU 40
- Status last verified
- Apr 2026
- First submitted
- 4 Jun 2021
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD can be shared upon request to the sponsor