ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ab… (NCT04916613) | Clinical Trial Compass
RecruitingPhase 3
ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)
Belgium, France300 participantsStarted 2022-04-19
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. 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.
✓. 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;
Exclusion criteria
✕. 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).
What they're measuring
1
Radiographic progression-free survival
Timeframe: From randomisation to radiographic progression or death, up to 18 months
. 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.