Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (DASL-HiCaP)

  • End date
    Jul 31, 2028
  • participants needed
  • sponsor
    University of Sydney
Updated on 3 April 2023
neutrophil count
antiandrogen therapy
androgen suppression
luteinizing hormone-releasing hormone agonist
luteinizing hormone
external beam radiation therapy
immunological adjuvant
external beam radiotherapy
extracapsular extension


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.


This trial aims to demonstrate that the use of darolutamide (in addition to standard of care) will be more effective than current standard of care in enhancing the ability of prostate or prostate bed radiation and 96 weeks of androgen suppression in decreasing the number of patients who develop metastases and subsequently die of prostate cancer. Darolutamide is a novel antagonist of the AR with favourable tolerability due to negligible penetration of the blood-brain barrier. Emergence of metastatic disease is the lethal event after local therapy, either with prostatectomy or definitive radiation. Augmenting adjuvant systemic therapy (either ADT or ADT plus docetaxel) with darolutamide has the potential to eradicate micrometastatic disease after either type of local therapy and decrease the death rate from prostate cancer.

This pragmatic design incorporates current standard of care for all patients and the option for docetaxel to be added to ADT. As such, the data will be applicable for all patients with very high risk prostate cancer treated with local therapy and will be the first study incorporating docetaxel use as one of the standard of care options. Even if docetaxel is definitively proven to improve MFS and OS in the adjuvant setting, not all patients will be fit for docetaxel. This will be the first trial that has the potential to build upon current and future advances that may emerge and be the most effective strategy to decrease death rate from prostate cancer in the near term if it further augments docetaxel efficacy in chemo-fit patients.

Condition Prostate Cancer
Treatment External Beam Radiotherapy, Placebo Oral Tablet, Darolutamide, Luteinizing Hormone-Releasing Hormone Analog
Clinical Study IdentifierNCT04136353
SponsorUniversity of Sydney
Last Modified on3 April 2023


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