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New treatment option for Prostate Cancer Metastatic
Official title ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)
ClinicalTrials.gov ID: NCT04916613
What this study is testing
What is Darolutamide 300 mg?
Darolutamide 300 mg is an investigational medicine, being studied as a potential treatment for prostate cancer metastatic.
Also referred to as Nubeqa®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 10 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- At least one extra-pelvic lymph node ≥2 cm
You likely can't join if
- Three or more Grade 3, or any Grade 4 events on the CISR-G questionnaire. Nota Bene: (Regarding CISR-G assessment, more specifically genitourinary...
- 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...
- Acute toxicities of prior treatments and procedures not resolved to grade ≤1 or baseline before randomisation, with the exception of hot flushes and...
- 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.
See the full eligibility criteria
Who can 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...
- 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...
- 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.
What rules you out
- 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.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Charleroi, Belgium
- Haine-Saint-Paul, Belgium
- Namur, Belgium
- Ottignies, Belgium
- Avignon, France
- Bayonne, France
- Besançon, France
- Beuvry, France
- Bordeaux, France
- Brest, France
- Caen, France
- Chambéry, France
- Clermont-Ferrand, France
- Colmar, France
- Créteil, France
- Dijon, France
- Grenoble, France
- La Réunion, France
- La Roche-sur-Yon, France
- Le Mans, France
+ 60 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleroi, Belgium; Haine-Saint-Paul, Belgium; Namur, Belgium; Ottignies, Belgium; Avignon, France; Bayonne, France and 74 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.