SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer (NCT05826509) | Clinical Trial Compass
Active — Not RecruitingPhase 2
SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer
France240 participantsStarted 2023-08-10
Plain-language summary
This is a phase II, multicenter, randomized open-label and comparative trial designed to study the effectiveness and the safety of androgen receptor antagonist (darolutamide) combined with surgery in patients with high-risk and/or locally advanced prostate cancer.
In this trial, patients will be assigned in one of the two following treatments arms:
* Arm A (control arm): Surgery alone (radical prostatectomy with lymph node dissection)
* Arm B (experimental arm): Peri-operative darolutamide + surgery (radical prostatectomy with lymph node dissection)
A total of 240 patients will have to be randomized with 120 patients in the control arm and 120 patients in the experimental arm.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Age ≥18 years
✓. Histologically confirmed adenocarcinoma of the prostate
✓. High-risk and/or locally advanced prostate cancer diagnosis defined by:
✓. No distant metastasis confirmed by imaging (i.e., MRI/CT-Scan and Bone Scintigraphy or PET-Scan)
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1
✓. Patient eligible for radical prostatectomy as per the investigator
✓. Adequate organ function within 28 days prior to start of treatment determined by the following central laboratory values:
✓. Patient able to receive darolutamide for up to 9 months as per the investigator
Exclusion criteria
✕. Distant metastasis (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
✕
What they're measuring
1
The non-curable progression-free survival (NC-PFS) defined as the time from randomization to non-curable event.
. Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
✕. Prior treatment for prostate cancer
✕. Castrated men (Bilateral orchiectomy or other)
✕. History of any pelvic radiation
✕. Any of the following concurrent illness within 6 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary
✕. Uncontrolled hypertension as indicated by a systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 100 mmHg at screening despite medical management. Participants with hypertension can enroll provided BP is stable and controlled by anti-hypertensive treatment
✕. HIV-positive patient with one or more of the following: Not receiving highly active antiretroviral therapy; Had a change in antiretroviral therapy within 6 months of the start of screening; Receiving antiretroviral therapy that may interfere with study drug; CD4 count \<350 at screening; AIDS-defining opportunistic infection within 6 months of start of screening