Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (NCT04136353) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate
United States1,100 participantsStarted 2020-03-31
Plain-language summary
The purpose of this study is to determine the effectiveness of darolutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at very high risk of recurrence.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Men aged 18 years and older, with pathological diagnosis of adenocarcinoma of the prostate
✓. EITHER planned for primary RT and judged to be at very high risk for recurrence based on any of the following:
✓. Adequate bone marrow function: Haemoglobin ≥ 100g/L, white cell count (WCC) ≥ 4.0x109/L, absolute neutrophil count (ANC) ≥ 1.5x109/L and platelets \> 100 x 109/L
✓. Adequate liver function: alanine aminotransferase (ALT) \< 2 x upper limit of normal (ULN) and total bilirubin \< 1.5 x ULN, (or if total bilirubin is between 1.5 - 2 x ULN, they must have a normal conjugated bilirubin)
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
✓. Study treatment both planned and able to start within 7 days after randomisation
✓. Willing to complete health-related quality of life (HRQL) questionnaires UNLESS is unable to complete because of literacy or limited vision
Exclusion criteria
✕1. Prostate cancer with predominant non-adenocarcinoma features (sarcomatoid or spindle cell or neuroendocrine small cell or squamous cell components or other non-adenocarcinoma)
✕2. Involvement of LNs by conventional CT imaging superior to the common iliac artery bifurcation, and/or outside the pelvis (distant LNs). LN involvement is defined by histopathological confirmation, or by a short axis measurement \> 10mm on standard imaging (CT or MRI, but not PET).
What they're measuring
1
Metastasis-free survival
Timeframe: Through study completion, an average of 5 years
✕3. Evidence of metastatic disease. Minimum imaging requirements to exclude metastatic disease are diagnostic quality imaging of both the pelvis and the abdomen (CT or MRI), chest (CXR or CT), and a whole body radioisotope bone scan (WBBS).
✕4. PSA \> 100 ng/mL at any time
✕5. Any prior use of new generation potent AR inhibition (abiraterone, enzalutamide, apalutamide, darolutamide or similar agents).
✕6. Prior endocrine therapy for prostate cancer except for the following which are allowed:
✕7. Bilateral orchidectomy
✕8. Prior pelvic brachytherapy or other radiotherapy that would result in an overlap of radiotherapy fields that would preclude the required RT