Nubeqa® Darolutamide
DASL-HiCaP Study
SUMMARY
The DASL-HiCaP study is an ongoing phase 3, randomized, double-blind, placebo-controlled, multicenter study evaluating darolutamide in combination with a luteinizing hormone releasing hormone analogue (LHRHA) and definitive or salvage radiotherapy in patients with very highrisk localized prostate cancer. Currently, no results are available.1-3
The study has enrolled 1107 patients with very high-risk localized prostate cancer or very high-risk features with prostate-specific antigen (PSA) persistence/rise following radical prostatectomy within the last 12 months, who are suitable for external beam radiotherapy and have no distant metastases.
- Patients will be randomized 1:1 to receive an LHRHA with either darolutamide or placebo, in addition to radiotherapy commencing within 8-24 weeks post-randomization.
- The primary study objective is metastasis-free survival. Secondary study objectives include: overall survival, prostate cancer-specific survival, PSA progression-free survival, time to subsequent hormonal therapy, time to onset of castration-resistance, frequency and severity of adverse events, change in health-related quality of life, and fear of cancer recurrence.
This page is intended for US healthcare professionals and may contain information outside of the approved prescribing information. It is provided in response to an unsolicited request. It is not intended as an endorsement of any usage not contained in the Prescribing Information. This response should be reviewed together with the current full Prescribing Information (including Boxed Warning) and Medical Safety Summary. These materials contain the approved indications, contraindications, warnings and precautions, adverse reactions, and other important safety information for Nubeqa® Darolutamide
Nubeqa is an androgen receptor inhibitor indicated for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC), metastatic castration-sensitive prostate cancer (mCSPC), and metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
CLINICAL DATA
DASL-HiCaP Study
The DASL-HiCaP study (Darolutamide Augments Standard Therapy for Localised Very High Risk Cancer of the Prostate; NCT04136353) is an ongoing phase 3, randomized, double-blind, placebo-controlled, multicenter study evaluating darolutamide in combination with an LHRHA and radiotherapy in patients with very high-risk localized prostate cancer1,2
Study Design/Methods
Figure. Study Design1
Key: AE, adverse event; EBRT, external beam radiotherapy; CRPC, castration-resistant prostate cancer; CT, computed tomography; LHRHA, luteinizing hormone releasing hormone analogue; MRI, magnetic resonance imaging; PSA, prostate-specific antigen; R, randomized; RP, radical prostatectomy; RT, radiotherapy; wks, weeks.
aAllow pelvic node
bRadiotherapy commencing within 8-24 weeks post-randomization
- Patients will be followed-up throughout the accrual period (estimated 3 years) and for an additional 4 years until 130 events, with a planned interim analysis after ~67% of events.
Patient Characteristics
Table. Baseline Characteristics3
Characteristic, n (%) | All Patients (N=1107) | ||||
Gleason Score | |||||
7 | 45 (4) | ||||
8 | 253 (23) | ||||
9 | 768 (69) | ||||
10 | 37 (3) | ||||
Clinical tumor stage | |||||
cT2 | 355 (33) | ||||
cT3 | 455 (41) | ||||
cT4 | 31 (3) | ||||
PSA >20 ng/mL | 256 (23) | ||||
Nodal involvement | 317 (29) | ||||
Primary radiotherapy cohort | 936 | ||||
NCCN risk factorsa,b | |||||
Missing | 3 (0.3) | ||||
1 risk factor | 281c(30) | ||||
2-3 risk factors | 424 (45) | ||||
cN1 | 228 (24) | ||||
Prostatectomy patients | 171 (15) | ||||
Planned adjuvant docetaxel | 15 (1) | ||||
Region | |||||
Australia / New Zealand | 621 (56) | ||||
United States / Canada | 391 (35) | ||||
Europe | 95 (9) | ||||
Key: cN, clinical node; cT, clinical tumor; NCCN, National Comprehensive Cancer Network; PSA, prostate-specific antigen aNCCN risk factors includes Gleason score 8-10, clinical tumor grade cT3-4, and PSA >20 ng/mL. bPercentages are calculated using the total number of primary radiotherapy patients (n=936). cGleason grade group 5 was the present risk factor in 78% of patients with a singular risk factor. | |||||
Table was adapted from Table. 1 in Niazi T, Nguyen P, Williams S, et al. Baseline disease characteristics of participants enrolled on ENZARAD (ANZUP 1303) and DASL-HiCaP (ANZUP 1801) trials of highly effective androgen receptor antagonists in high-risk localized or locally advanced prostate cancer (PCa). Poster presented at: American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium; January, 24-27, 2024; San Francisco, CA. [downloaded 08 December 2025] Copyrights remain with the original source or as denoted therein.
LITERATURE SEARCH
A literature search of Embase®, PubMed, and/or other resources, including internal/external databases, was conducted pertaining to this topic on 08 December 2025.
REFERENCES
All the references were accessed on the abovementioned literature search date.
- Niazi T, McBride SM, Williams S, et al. DASL-HiCaP: Darolutamide Augments Standard therapy for Localized very High-risk Cancer of the Prostate –a randomized phase 3 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 (ANZUP 1801). Poster presented at: American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium; February, 16-18, 2023; San Francisco, CA.
- NCT04136353. DASL-HiCaP: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801): A Randomised Phase 3 Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localised Prostate Cancer. Updated July 28, 2023. Accessed via https://clinicaltrials.gov/study/NCT04136353
- Niazi T, Nguyen P, Williams S, et al. Baseline disease characteristics of participants enrolled on ENZARAD (ANZUP 1303) and DASL-HiCaP (ANZUP 1801) trials of highly effective androgen receptor antagonists in high-risk localized or locally advanced prostate cancer (PCa). Poster presented at: American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium; January, 24-27, 2024; San Francisco, CA.
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