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    Summary
    EudraCT Number:2020-003663-26
    Sponsor's Protocol Code Number:UC-GTG-2006
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-12-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-003663-26
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)
    A.3.2Name or abbreviated title of the trial where available
    PEACE 6 - Vulnerable
    A.4.1Sponsor's protocol code numberUC-GTG-2006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04916613
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUNICANCER
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUNICANCER
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnicancer
    B.5.2Functional name of contact pointIsabelle RIEGER
    B.5.3 Address:
    B.5.3.1Street Address101 rue de Tolbiac
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75013
    B.5.3.4CountryFrance
    B.5.4Telephone number33(0)1 80 50 15 99
    B.5.6E-mailvulnerable@unicancer.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name NUBEQA 300 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG 51368 Leverkusen Germany
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDAROLUTAMIDE
    D.3.9.1CAS number 1297538-32-9
    D.3.9.3Other descriptive nameBAY 1841788
    D.3.9.4EV Substance CodeSUB185326
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adenocarcinoma of the prostate
    E.1.1.1Medical condition in easily understood language
    Metastatic prostate cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of ADT + darolutamide vs ADT + placebo in terms of radiographic progression-free survival (rPFS) in patients with castration-naïve de novo metastatic prostate cancer with vulnerable functional ability and not elected for docetaxel or other androgen receptor pathway inhibitors.
    E.2.2Secondary objectives of the trial
    Key Secondary objectives:
    -To assess the efficacy of ADT + darolutamide vs ADT + placebo in terms of:
    o Castration-resistant prostate cancer-free survival
    o Clinical progression-free survival (cPFS)
    o Overall survival

    -To assess the safety profile of the ADT + darolutamide combination.

    Other secondary objectives:
    -Time to worsening in prostate cancer-related urinary symptoms
    - Time to next symptomatic skeletal event
    - Prostate specific antigen (PSA) response
    - Prostate cancer-specific survival
    - To assess the effect of ADT + darolutamide on subsequent lines of therapy
    - To evaluate the evolution of quality of life and geriatric status in individuals during the treatment period.
    - To evaluate the impact of sarcopenia on survival and treatment response.

    EXPLORATORY OBJECTIVES
    - To identify the oncogenic drivers of de novo metastatic prostate cancer.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Same version as protocol (v2.0 - March 21th 2022 - section 9) BIOLOGICAL ANCILLARY/TRANSLATIONAL STUDIES

    1. Samples
    Blood samples and tumour tissue will be collected across all trials in the PEACE 6 programme to address two current critical questions:
    (i) What are the oncogenic drivers of de novo metastatic prostate cancer?
    (ii) What is the underlying biology of oligometastatic prostate cancer?
    Analyses will include:
    Exome analysis
    Transcriptome analysis
    Immunohistochemistry
    Circulating tumour cells

    2. Sarcopenia
    Additional data will be collected for consenting patients in order to answer the following secondary objectifve: what is the impact of sarcopenia on survival and treatment response?
    A complementary clinical evaluation will be performed by investigators and recorded in the eCRF at each timepoint, from Screening to End of treatment:
    - Abdominal circumference, weight and height and body mass index (BMI)
    - Maximum handgrip strength using a hand dynamometer
    E.3Principal inclusion criteria
    1. Signed a written informed consent form prior to any trial specific procedures.
    Note: If the patient is physically unable to provide their written consent, a trusted person of their choice, independent of the Investigator or the Sponsor, can confirm the patients consent in writing.
    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 radiographic 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:
    a. Activities of daily living (ADL) assessment (excluding urinary incontinence question) score 3 or 4/5;
    b. 4-Instrumental activities of daily living (4-IADL) assessment score 2 or 3/4;
    c. A Grade 3 event on the Cumulative Illness Score Rating-Geriatrics (CISR-G) questionnaire;
    d. Body mass index (BMI) ≤21 kg/m2 and/or >5% weight loss in the last 6 months;
    e. Timed up and go test (TUG) >14 sec.
    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 MDRD or 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
    E.4Principal exclusion criteria
    1. Three or more Grade 3, or any Grade 4 events on the CISR-G questionnaire.
    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
    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 of full age deprived of liberty or placed under a legal protection measure (tutorship/curatorship/temporary guardianship).
    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.
    E.5 End points
    E.5.1Primary end point(s)
    Radiographic progression-free survival, defined as time from randomisation to radiographic progression as assessed by the investigator according to PCWG3 criteria, or death, whichever occurs first.
    According to the PCWG3 recommendations, radiographic progression is defined as either the appearance of two or more new bone lesions on bone scan or a nodal or visceral progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1). The date of radiographic progression will be the date of the first reported event meeting the above definition.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patient’s disease will be assessed at “baseline” (during the screening period) and then every 120 (±14) days after randomisation during the first 2 years and every 180 (±14) days thereafter, until documented radiographic progression, or death, whichever occurs first.
    E.5.2Secondary end point(s)
    Key secondary endpoints:
    - Castration-resistant prostate cancer (CRPC)-free survival, defined as the time from randomisation to onset of CRPC according to PCWG3 criteria, or death, whichever occurs first.
    - Clinical progression-free survival, defined as time from randomisation to first occurrence of any one of the following:
    o Cancer pain deterioration (2-point deterioration from baseline according to the Brief Pain Inventory - Short Form [BPI-SF] questionnaire, or initiation of opioid therapy, or a ≥30% increase in opiate use),
    o Any deterioration of physical function measured using the 4-IADL assessment tool,
    o A deterioration in ECOG performance status of at least 2 points from baseline,
    o Death from any cause.
    - Overall survival, defined as the time from randomisation to the time of death from any cause. For subjects alive at the time of analysis, data will be censored on the last date the subject was known to be alive or lost to follow-up or withdraw consent.
    - Toxicity will be evaluated according to version 5 of the National Cancer Institut - Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0).
    Other secondary endpoints
    - Time to worsening in prostate cancer-related urinary symptoms, defined as an 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 European organisation for research and treatment of cancer (EORTC) quality of life questionnaire (QLQ) (EORTC-QLQ-PR25).
    - Time to next symptomatic skeletal event, defined as the time from randomisation until first occurrence of one of the following: a symptomatic fracture, radiation or surgery to bone or a spinal cord compression (PCWG3 criteria).
    Note: The occurrence of these events will be determined by investigator evaluation. No systematic X-Ray will be performed.
    - Complete PSA response (defined as PSA ≤ 0.2 ng/ml) at 6 months.
    - Prostate cancer-specific survival, defined as the time from randomisation to the date of death due to prostate cancer (deaths due to other causes will be censored).
    - 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.
    - Time to first subsequent systemic anti-cancer therapy (SACT) defined as the time from randomisation to the date of initiation of any SACT for CRPC, following initiation of the study treatment.
    - Efficacy of subsequent SACT will be assessed according to rPFS, OS, and PFS after next line of treatment (PFS2); defined as the time from randomisation to second objective disease progression, or death from any cause, whichever first.
    - Health related quality of life will be evaluated using the EORTC-QLQ-C30, EORTC-QLQ-PR25 and BPI-SF questionnaires.
    - Geriatric status will be evaluated using the Geriatric Core Dataset (G-Code) assessment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be asked to attend clinical visits to perform safety and efficacy assessments on Day 30 (±3 days), Day 60 (±3 days), Day 120 (±7 days), Day 180 (±7 days), Day 240 (±7 days) and then every 120 (±14) days for the first two years of treatment and every 180 (±14) days thereafter. Response to treatment will be assessed according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria by radiographic exams performed every 120 (±14) days after randomisation during the first 2 years and every 180 (±14) days thereafter.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    All patients (experimental and control arm) will receive Androgen deprivation therapy (ADT)
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA98
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of trial is defined as last visit of the last subject(LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years15
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 290
    F.4.2.2In the whole clinical trial 300
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After discontinuation of trial treatment, subsequent therapy decisions are left to the physician’s discretion.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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