Status: Closed
Activation Date: 2020NOV27
Closing Date: 2023JUL14
Phase: III
Description: DASL-HiCaP: Darolutamide Augments Standard Therapy for Localized Very High-Risk Cancer of the Prostate. A Randomized Phase III Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localized Prostate Cancer
Eligibility: Men with either very high-risk localized prostate cancer or very high-risk features with PSA persistence/rise within 12 months following radical prostatectomy, suitable for EBRT with or without brachytherapy. CT/MRI and bone scan negative for distant metastases (allow pelvic LN).
Objective: Primary: Metastasis-free survival Secondary: Overall survival; prostate cancer-specific survival; PSA-progression free survival; time to subsequent hormonal therapy; time to castration-resistance; frequency and severity of adverse events; health-related QoL; fear of cancer recurrence Tertiary: Incremental cost-effectiveness; prognostic/predictive biomarkers
Participation: Limited to invited centres
Lay Description: 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.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GENITO-URINARY | PR22 | 318 | 104 | 106 | 156 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| GENITO-URINARY | PR22 | 318 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| GENITO-URINARY | PR22 | 318 | 165 | 0 | 0 | 0 | 172 | 172 | 0 | 0 |