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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Darolutamide; Drug: Luteinizing Hormone-Releasing Hormone Analog; Radiation: External Beam Radiotherapy; Drug: Placebo oral tablet

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Border Medical Oncology Research Unit
    • Gosford, New South Wales, Australia, 2250
      • Gosford Hospital
    • Newcastle, New South Wales, Australia, 2298
      • Calvary Mater Newcastle
    • Newcastle, New South Wales, Australia, 2290
      • GenesisCare Newcastle
    • Nowra, New South Wales, Australia, 2541
      • Shoalhaven District Memorial Hospital
    • Sydney, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse
    • Sydney, New South Wales, Australia, 2170
      • Liverpool Hospital
    • Sydney, New South Wales, Australia, 2076
      • Sydney Adventist Hospital
    • Sydney, New South Wales, Australia, 2031
      • Prince of Wales Hospital
    • Sydney, New South Wales, Australia, 2217
      • St George Hospital
    • Sydney, New South Wales, Australia, 2065
      • Northern Cancer Institute
    • Sydney, New South Wales, Australia, 2560
      • Campbelltown Hospital
    • Sydney, New South Wales, Australia, 2010
      • St Vincent's Public Hospital
    • Wollongong, New South Wales, Australia, 2500
      • Wollongong Hospital
  • Queensland
    • Brisbane, Queensland, Australia, 4101
      • ROPART
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital
    • Southport, Queensland, Australia, 4215
      • Icon Cancer Centre
    • Townsville, Queensland, Australia, 4814
      • Townsville Hospital
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Kurralta Park, South Australia, Australia, 5037
      • Ashford Cancer Centre Research
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Royal Hobart Hospital
    • Hobart, Tasmania, Australia, 7000
      • Icon Cancer Centre Hobart
  • Victoria
    • Bendigo, Victoria, Australia, 3550
      • Peter MacCallum Cancer Centre - Bendigo Campus
    • Bentleigh East, Victoria, Australia, 3165
      • Peter MacCallum Cancer Centre (Moorabbin Campus)
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • Malvern, Victoria, Australia, 3144
      • GenesisCare Cabrini (Gandel Wing), Cabrini Hospital Malvern
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre
    • St Albans, Victoria, Australia, 3021
      • Sunshine Hospital
    • Traralgon, Victoria, Australia
      • Latrobe Regional Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6143
      • Fiona Stanley Hospital
    • Nedlands, Western Australia, Australia, 6006
      • Sir Charles Gairdner Hospital
• Canada
  • Québec, Canada, G8Z 3R9
    • Centre Hospitalier Regional de Trois-Rivieres
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 1Z2
      • BC Cancer Agency (BCCA) Fraser Valley
  • Manitoba
    • Brandon, Manitoba, Canada, R7A 2B3
      • Western Manitoba Cancer Centre - Prairie Mountain Health
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • CancerCare Manitoba
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Regional Health Authority B, Zone 2 Saint John Regional Hospital
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Dr. H. Bliss Murphy Cancer Centre, St. John's
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston Health Sciences Centre
    • London, Ontario, Canada, B3H 1V7
      • Queen Elizabeth Ii Health Sciences Centre
    • Sault Ste. Marie, Ontario, Canada, P6B 0A8
      • Sault Area Hospital - Algoma District Cancer Program
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
    • Toronto, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Research Institute
    • Toronto, Ontario, Canada, M4N 3M5
      • Odette Cancer Centre - Sunnybrook Hospital
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
    • Montreal, Quebec, Canada
      • Centre Hospitalier de l'Université de Montréal
    • Québec, Quebec, Canada, G1R 2J6
      • Hotel-Dieu de Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Allan Blair Cancer Centre
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre
• Ireland
  • Cork, Ireland, T12 EC8P
    • Cork University Hospital
  • Cork, Ireland, T23
    • Bon Secours Hospital Cork in association with UPMC Hillman Centre
  • Dublin, Ireland, D24 NR0A
    • Tallaght University Hospital
  • Dublin, Ireland, D07 A8NN
    • Mater Misericordiae University Hospital
  • Dublin, Ireland, D07 WKW8
    • Mater Private Dublin
  • Dublin, Ireland, D08 T6T8
    • St Luke's Radiation Oncology Network at St James's Hospital
  • Dublin, Ireland, D18 AK68
    • Beacon Private Hospital Dublin
  • Galway, Ireland, H91 YR71
    • Galway University Hospital
  • Dublin 6
    • Rathgar, Dublin 6, Ireland, D06 E1C9
      • St. Luke's Hospital
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital
  • Palmerston North, New Zealand, 4442
    • Palmerston North Hospital
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
    • Aberdeen Royal Infirmary
  • Ashford, United Kingdom, TN24 0LZ
    • William Harvey Hospital
  • Bath, United Kingdom, BA1 3NG
    • Royal United Hospital Bath
  • Belfast, United Kingdom, BT9 7AB
    • Belfast City Hospital
  • Canterbury, United Kingdom, CT1 3NG
    • Kent and Canterbury Hospital
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital
  • Glasgow, United Kingdom, G12 0YN
    • Beatson West of Scotland Cancer Centre
  • London, United Kingdom
    • Royal Marsden Hospital
  • London, United Kingdom, SE1 9RT
    • Guy's and St Thomas Hospital
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham University Hospitals NHS Trust - Nottingham City Hospital
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Brighton, Massachusetts, United States, 02135
      • Dana Farber Cancer Institute - St. Elizabeth's
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital and Medical Center
    • Milford, Massachusetts, United States, 01757
      • Dana Farber Cancer Institute - Milford
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • XCancer Omaha/Urology Cancer Center
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge
    • Clifton, New Jersey, United States, 07013
      • New Jersey Urology Saddle Brook
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen
    • Voorhees Township, New Jersey, United States, 08043
      • New Jersey Urology Voorhees
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • New Mexico Oncology and Hematology Specialists
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester
    • Mineola, New York, United States, 11501
      • New York University Langone Long Island
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10016
      • New York University Langone Medical Center
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering Nassau
  • Ohio
    • Kettering, Ohio, United States, 45409
      • Dayton Physicians Network
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Men aged 18 years and older, with pathological diagnosis of adenocarcinoma of the prostate

2. EITHER planned for primary RT and judged to be at very high risk for recurrence based on any of the following:

   • Grade Group 5, OR
   • Grade Group 4 AND one or more of the following: clinical T2b-4 OR MRI with seminal vesicle invasion OR extracapsular extension OR PSA* > 20ng/mL, OR
   • Pelvic nodal involvement (involvement of lymph nodes (LNs) at or below the bifurcation of the aorta into the common iliac arteries) defined radiologically as greater than 10mm on short axis using standard CT or MRI, or pathologically confirmed (PSMA PET alone is not considered enough if ≤ 10mm) OR

   Post-radical prostatectomy ≤ 365 days prior to randomisation and planned for RT with PSA* ≥ 0.1 ng/mL that has risen or remained stable (within ≤ 0.05 ng/mL) since a previous level at least 1 week earlier, judged to be at very high risk for recurrence based on any of the following:

   • Grade Group 5, OR
   • Grade Group 4 AND pT3a or higher, OR
   • Pelvic nodal involvement (involvement of LNs at or below the bifurcation of the aorta into the common iliac arteries) defined radiologically as greater than 10mm on short axis using standard CT or MRI, or pathologically confirmed (PSMA PET alone is not considered enough if ≤ 10mm) * This PSA level must be measured within 60 days prior to randomisation. However, if a participant has already commenced endocrine therapy (ET) for prostate cancer, this PSA level must be measured within 180 days prior to commencing ET.
3. 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
4. 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)
5. Adequate renal function: calculated creatinine clearance > 30 mL/min (Cockroft-Gault)
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
7. Study treatment both planned and able to start within 7 days after randomisation
8. Willing to complete health-related quality of life (HRQL) questionnaires UNLESS is unable to complete because of literacy or limited vision
9. Willing and able to comply with all study requirements, including standard of care treatment such as EBRT, timing and/or nature of required assessments

10. Signed, written informed consent

    Exclusion Criteria:

11. Prostate cancer with predominant non-adenocarcinoma features (sarcomatoid or spindle cell or neuroendocrine small cell or squamous cell components or other non-adenocarcinoma)
12. 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).

13. 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).

    • If endocrine therapy (ET) had not started, imaging must be within 60 days prior to randomisation.
    • If ET has been started, imaging must have been performed no more than 60 days prior to starting ET and no more than 30 days after starting ET and prior to randomisation.
14. PSA > 100 ng/mL at any time
15. Any prior use of new generation potent AR inhibition (abiraterone, enzalutamide, apalutamide, darolutamide or similar agents).

16. Prior endocrine therapy for prostate cancer except for the following which are allowed:

    • (i) LHRHA and/or (ii) a first-generation nonsteroidal antiandrogen (NSAA) are allowed if commenced no more than 90 days before randomisation. If an NSAA has been used, it must be stopped before starting study treatment with darolutamide/placebo; and
    • Prior use of 5-alpha reductase inhibitor is allowed and if used it must be stopped before starting study treatment with darolutamide/placebo
17. Bilateral orchidectomy
18. Prior pelvic brachytherapy or other radiotherapy that would result in an overlap of radiotherapy fields that would preclude the required RT

19. History of

    • Loss of consciousness or transient ischemic attack or stroke within 6 months prior to randomisation, or
    • Significant cardiovascular disease within 6 months prior to randomisation: including myocardial infarction, unstable angina, congestive heart failure (NYHA grade II or greater), ongoing arrhythmias of Grade > 2 (CTCAE v5.0), thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism), coronary artery bypass graft. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
20. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of darolutamide, including difficulty swallowing tablets
21. History of another malignancy within 5 years prior to randomisation except for those malignancies treated with curative intent with a predicted risk of relapse of less than 10% including but not limited to non-melanoma carcinoma of the skin; or adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (i.e. Tis, Ta and low grade T1 tumours). All such cases with a history of malignancy within the last 5 years are to be discussed with study team before randomisation. Melanoma in-situ and other adequately treated in-situ neoplasms are not considered malignancies for the purposes of eligibility assessment.
22. Concurrent illness, including severe infection that might jeopardise the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety (HIV infection is not an exclusion criterion if it is controlled with anti-retroviral drugs that are unaffected by concomitant darolutamide)
23. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse

24. Patients who are sexually active with women of child-bearing potential and not willing/able to use medically acceptable and highly effective forms of contraception during study treatment and for at least 4 weeks after completion of study treatment. Contraception must include:

    • Condom use (also required if sexual partner is pregnant), and
    • Additional birth control with low failure rate (less than 1% per year) when used consistently and correctly. E.g. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, true sexual abstinence.

    True sexual abstinence will only be an acceptable form of contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to study treatment, and withdrawal are not acceptable methods of contraception.

25. Participation in other clinical trials of investigational agents for the treatment of prostate cancer or other diseases
26. Major surgery within 21 days prior to randomisation
27. Patients with history of hypersensitivity to the study treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Darolutamide; Darolutamide 600mg (2 x 300mg tablets) twice daily by mouth for 96 weeks, adherence monitored by participant report. All participants are treated with an LHRHA for 96 weeks from randomisation and external beam radiation therapy started within 8-24 weeks after randomisation.	Drug: Darolutamide; 2 x 300mg oral tablets twice daily for 96 weeks; Drug: Luteinizing Hormone-Releasing Hormone Analog; All participants are to receive standard background therapy with an LHRHA, as per standard of care. The choice of LHRHA is at the discretion of the treating clinician.; Radiation: External Beam Radiotherapy; All participants are to receive standard background therapy with curative-intent RT to the prostate or prostate bed as well as the pelvic lymph nodes using EBRT.
Placebo Comparator: Placebo; Placebo (2 tablets) twice daily by mouth for 96 weeks, adherence monitored by participant report. All participants are treated with an LHRHA for 96 weeks from randomisation and external beam radiation therapy started within 8-24 weeks after randomisation.	Drug: Luteinizing Hormone-Releasing Hormone Analog; All participants are to receive standard background therapy with an LHRHA, as per standard of care. The choice of LHRHA is at the discretion of the treating clinician.; Radiation: External Beam Radiotherapy; All participants are to receive standard background therapy with curative-intent RT to the prostate or prostate bed as well as the pelvic lymph nodes using EBRT.; Drug: Placebo oral tablet; 2 oral tablets twice daily for 96 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metastasis-free survival	Evidence of metastases includes findings on WBBS or CT or MRI (as reported by the site investigator) that are either characteristic of metastatic prostate cancer, and/or confirmed by other test results e.g. cytology or histopathology.	Through study completion, an average of 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival is defined as the interval from the date of randomisation to date of death from any cause, or the date of last known follow-up alive.	Through study completion, an average of 5 years
Prostate cancer-specific survival	Prostate cancer-specific survival is defined as the interval from the date of randomisation to the date of last known follow-up alive, or the date of death from prostate cancer. Deaths from other causes will be summarised.	Through study completion, an average of 5 years
PSA-progression free survival	For participants who receive definitive radiotherapy (i.e. without radical prostatectomy), PSA progression is defined by the Phoenix criteria (requires confirmation by a repeat PSA performed at least 3 weeks later). For participants who have undergone a radical prostatectomy, an increase in PSA of >0.2 ng/mL above the nadir would be considered PSA progression (requires confirmation by a repeat PSA performed at least 3 weeks later).	Through study completion, an average of 5 years
Time to subsequent hormonal therapy	Time to subsequent hormone therapy is the interval from randomisation to the first date that endocrine therapy is recommenced or changed for the treatment of recurrent (or progressive) prostate cancer.	Through study completion, an average of 5 years
Time to castration-resistance	Defined according to the PCWG3 criteria. If a participant has radiographic progression without serological progression, this will also be deemed castration resistant prostate cancer	Through study completion, an average of 5 years
Frequency and severity of adverse events (CTCAE v5.0, RTOG/EORTC acute/late radiation morbidity criteria)	Safety reporting will describe the frequency and severity of AEs. The CTCAE v5.0 will be used to classify and grade the intensity of AEs occurring until 30 days after the last dose of study treatment. The RTOG/EORTC Scoring Criteria will be used to assess morbidities related to radiation therapy (RT) until 6 years after randomisation. Acute AEs are those occurring within 90 days after starting RT, and will be classified and graded according to the RTOG/EORTC Acute Radiation Morbidity Scoring Criteria. Late AEs are those occurring more than 90 days after starting RT, and will be classified and rated according to the RTOG/EORTC Late Radiation Morbidity Scoring Schema.	Approximately 12-weekly for 2 years from randomisation until 30 days after the last dose of study treatment.
Health-related quality of life	EORTC Core Quality of Life Questionnaire (QLQC-30). Importance of quality of life issues are assessed using a four-point scale (1 = not at all, 4 = very much) EORTC Quality of Life Questionnaire for Prostate Cancer (PR-25). Importance of quality of life issues are assessed using a four-point scale (1 = not at all, 4 = very much) Euroqol 5 item preference-based measure of health (EQ-5D-5L), comprising 5 questions with a score from 1 to 5 each and a visual analogue scale from 0 to 100.	Through study completion, an average of 5 years
Fear of cancer recurrence	Using the Fear of Cancer Recurrence Inventory (FCRI), a 42-item questionnaire with scores of 0 (never/not at all) - 4 (all the time/a great deal) for each.	Through study completion, an average of 5 years

Collaborators and Investigators

• Sponsor: University of Sydney
• Collaborators: Memorial Sloan Kettering Cancer Center; Bayer; Canadian Cancer Trials Group; Australian and New Zealand Urogenital and Prostate Cancer Trials Group; Cancer Trials Ireland; Prostate Cancer Clinical Trials Consortium
• Investigators: Study Chair: Christopher Sweeney, Dana-Farber Cancer Institute and Harvard Medical School; Study Chair: Tamim Niazi, Jewish General Hospital and McGill University

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2020
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: darolutamide; clinically localised prostate cancer; very high risk
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Gonadotropin-Releasing Hormone; darolutamide
• Other Study ID Numbers: ANZUP1801; U1111-1239-0771 (Other Identifier: WHO Universal Trial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No