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Darolutamide + Standard Therapy for Prostate Cancer (DASL-HiCaP Trial)

Phase 3
Waitlist Available
Research Sponsored by University of Sydney
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
EITHER planned for primary RT and judged to be at very high risk for recurrence based on any of the following: Grade Group 5, 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, 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, Grade Group 4 AND pT3a or higher, 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.,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),Adequate renal function: calculated creatinine clearance > 30 mL/min (Cockroft-Gault),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,Willing and able to comply with all study requirements, including standard of care treatment such as EBRT, timing and/or nature of required assessments,Signed, written informed consent
Men aged 18 years and older, with pathological diagnosis of adenocarcinoma of the prostate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 5 years
Awards & highlights

DASL-HiCaP Trial Summary

This trial will test if adding darolutamide to ADT with a LHRHA can help prevent prostate cancer from coming back in men at very high risk of recurrence after radiation therapy.

Who is the study for?
Men over 18 with high-risk localized prostate cancer, eligible for radiation therapy and at very high risk of recurrence. They must have a specific type of prostate cancer (adenocarcinoma), certain PSA levels, and no evidence of metastatic disease or previous potent AR inhibition treatments. Participants need good organ function, performance status, and must be willing to follow study procedures.Check my eligibility
What is being tested?
The trial is testing the effectiveness of darolutamide in combination with standard hormone therapy using LHRHA and external beam radiotherapy in men undergoing treatment for very high-risk localized prostate cancer. The goal is to see if adding darolutamide helps prevent cancer from coming back.See study design
What are the potential side effects?
Darolutamide may cause fatigue, digestive issues like nausea or diarrhea, skin rash, liver enzyme changes which could indicate liver damage, blood pressure changes, and can affect how other medications work.

DASL-HiCaP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man over 18 with a prostate cancer diagnosis.
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My kidneys work well enough, with a creatinine clearance over 30 mL/min.
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My liver tests are within the normal range.
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My blood tests show normal levels of hemoglobin, white cells, neutrophils, and platelets.

DASL-HiCaP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Metastasis-free survival
Secondary outcome measures
Fear of cancer recurrence
Frequency and severity of adverse events (CTCAE v5.0, RTOG/EORTC acute/late radiation morbidity criteria)
Health-related quality of life
+5 more

DASL-HiCaP Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DarolutamideExperimental Treatment3 Interventions
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.
Group II: PlaceboPlacebo Group3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External Beam Radiotherapy
1995
Completed Phase 3
~440
Darolutamide
2018
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

BayerIndustry Sponsor
2,237 Previous Clinical Trials
25,325,878 Total Patients Enrolled
38 Trials studying Prostate Cancer
24,819 Patients Enrolled for Prostate Cancer
Canadian Cancer Trials GroupNETWORK
124 Previous Clinical Trials
66,353 Total Patients Enrolled
10 Trials studying Prostate Cancer
6,035 Patients Enrolled for Prostate Cancer
Memorial Sloan Kettering Cancer CenterOTHER
1,933 Previous Clinical Trials
584,522 Total Patients Enrolled
132 Trials studying Prostate Cancer
50,974 Patients Enrolled for Prostate Cancer

Media Library

External Beam Radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT04136353 — Phase 3
Prostate Cancer Clinical Trial 2023: External Beam Radiotherapy Highlights & Side Effects. Trial Name: NCT04136353 — Phase 3
External Beam Radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04136353 — Phase 3
Prostate Cancer Research Study Groups: Darolutamide, Placebo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the main condition that Darolutamide treats?

"Darolutamide can be used to effectively treat ovarian issues such as hyperstimulation, anovulatory cycles, and hypogonadotropic ovarian failure."

Answered by AI

Does Darolutamide have any dangerous side effects?

"There is both efficacy and safety data available from prior clinical trials, so our team has given Darolutamide a score of 3."

Answered by AI

How many people are being observed in this clinical trial?

"Yes, the clinicaltrials.gov website currently says that this study is open for recruitment. This trial was originally announced on March 31st 2020 and has since been updated on November 7th 2022. There are 37 different locations enrolling a total of 1100 patients."

Answered by AI

What are the precedents for this research?

"Darolutamide has been investigated in clinical trials since 2016. The first study, which was sponsored by Orion Corporation and completed in 2016, recruited 1303 participants. After the initial research project was completed, Darolutamide received Phase 3 drug approval and is being trialed in 35 active studies taking place across 608 cities and 46 countries."

Answered by AI

In how many different geographical areas is this trial being conducted?

"Currently, 37 patients are enrolled in this study with locations including the Sault Area Hospital - Algoma District Cancer Program in Sault Ste Marie, Cross Cancer Institute in Edmonton, and Jewish General Hospital in Montréal."

Answered by AI

Are investigators looking for new participants at this time?

"This clinical trial, which is currently recruiting participants, was first posted on March 31st 2020. The most recent edit to the study occurred on November 7th 2022."

Answered by AI

Are there any other ongoing research projects that are using Darolutamide?

"Darolutamide is being researched in 35 clinical trials at the moment, 12 of which are in Phase 3. Although some of the London, Ontario-based studies for Darolutamide are coming to a close, there are 1988 locations worldwide where clinical trials for Darolutamide are still ongoing."

Answered by AI

Who else is applying?

What site did they apply to?
BC Cancer Agency (BCCA) Fraser Valley
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate
2020. "Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04136353.
All > Prostate Cancer Boston
~527 spots leftby Jan 2028
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