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Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)Phase 3ARASAFENCT05676203

A Trial Comparing Docetaxel 75 mg/m2 (3w) Versus Docetaxel 50 mg/m2 (2w) in Combination With Darolutamide + ADT in mHSPC Patients

A Phase 3 study testing Standard ADT (androgen deprivation therapy), Standard Darolutamide and Docetaxel in people with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), run by Jena University Hospital at 43 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this clinical phase 3 randomized trial is to compare two different dosing schedules of Docetaxel in combination with ADT and Darolutamide in subjects with mHSPC. The main question aims to compare grade 3-5 adverse events (AEs) in patients with mHSPC treated with 6 cycles of either Docetaxel 75 mg/m2… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Standard ADT (androgen deprivation therapy), Standard Darolutamide and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
43 sitesin 2 countries
Study dates
16 May 2023to Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • Males ≥18 years of age
  • Histologically or cytologically confirmed adenocarcinoma of prostate
  • Investigator assessed metastatic disease documented either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed. Metastatic disease is defined as either malignant lesions in bone scan or soft tissue/visceral lesions according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Lymph nodes are measurable if the short axis diameter is ≥15 mm, soft tissue/visceral lesions are measurable if the long axis diameter is ≥10 mm.
  • Subjects with lymph node metastases only (either below the aortic bifurcation (N1) or above the aortic bifurcation (M1a)) will not be eligible for the study.
  • Subjects must be candidates for ADT, docetaxel and darolutamide therapy per Investigator's judgment
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  • Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti-androgen, but no longer than 12 weeks before randomization. For subjects receiving LHRH agonists, treatment in combination with a first generation anti-androgen for at least 4 weeks, prior to randomization is recommended. First generation anti-androgen has to be stopped prior to randomization.
  • An Eastern Cooperative Oncology Group performance status of 0 or 1
  • Blood counts at Screening: hemoglobin ≥9.0 g/dL, absolute neutrophil count ≥1.5x109/L, platelet count ≥100x109/L (subject must not have received any growth factor within 4 weeks or a blood transfusion within 7 days of the hematology laboratory sample obtained at Screening)
  • Screening values of serum alanine aminotransferase and/or aspartate transaminase ≤1.5x upper limit of normal (ULN), total bilirubin ≤ULN, creatinine ≤2.0x ULN
  • Sexually active male subjects must agree to use condoms as an effective barrier method and refrain from sperm donation, and/or their female partners of reproductive potential to use a method of effective birth control, during the treatment with darolutamide and for 3 months after the end of the treatment with darolutamide and 6 months after treatment with docetaxel.

Who cannot join

  • Prior treatment with:
  • LHRH agonist/antagonists started more than 12 weeks before randomization Second-generation androgen receptor (AR) inhibitors such as enzalutamide, apalutamide, darolutamide, other investigational AR inhibitors
  • Cytochrome P 17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer
  • Chemotherapy, immunotherapy, radium or other therapeutic radiopharmaceuticals for prostate cancer (e.g. Lutetium177-PSMA) prior to randomization
  • Treatment with radiotherapy (external beam radiation therapy, brachytherapy) within 2 weeks before randomization
  • Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
Show all 16Show fewer
  • Contraindication to both CT and MRI contrast agent
  • Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris,coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)
  • Uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg despite medical management
  • Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed ≥5 years before randomization and from which the subject has been disease-free
  • A gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study drug
  • An active viral hepatitis, known human immunodeficiency virus infection with detectable viral load, or chronic liver disease with a need for treatment
  • Previous (within 28 days before the start of study drug or 5 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s)
  • Any other serious or unstable illness, or medical, social, or psychological condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results
  • Inability to swallow oral medications
  • Previous assignment to treatment in this study

Trial locations and contacts

43 sites in 2 countries.

43 sites in 2 countries

Germany41 sites

  • Marien Krankenhaus

    Bergisch Gladbach, 51465

  • Vivantes Prostatazentrum im Klinikum am Urban

    Berlin, State of Berlin, 10967

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Urologie Schlosscarree

    Braunschweig, 38100

  • UROLOGIE BAYENTHAL Gemeinschaftspraxis

    Cologne

  • Städtisches Klinikum Dessau

    Dessau, 06847

  • Urologicum Duisburg

    Duisburg, North Rhine-Westphalia, 47169

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Helios Klinikum Erfurt

    Erfurt, 99089

  • Uniklinikum Erlangen

    Erlangen, 91054

  • KEM | Evang. Kliniken Essen-Mitte

    Essen, 45136

  • Universitätsklinikum Essen

    Essen, 45147

  • Krankenhaus Nordwest

    Frankfurt am Main, 60488

  • Universitäts Klinikum Frankfurt

    Frankfurt am Main, 60590

  • Universitätsklinikum Giessen und Marburg GmbH, Standort Giessen

    Giessen, 35392

  • Krankenhaus Martha-Maria Halle Dölau gGmbH

    Halle, Saxony-Anhalt, 06120

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

  • Med. Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • St. Anna Hospital Herne

    Herne, 44625

  • University Hospital Jena, Department of Urology

    Jena, Thuringia, 07747

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    Lübeck

  • Universitätsklinikum Magdeburg

    Magdeburg, 39120

  • Universitätsmedizin Mannheim

    Mannheim, 68167

  • Universitätsklinikum Gießen und Marburg - Standort Marburg

    Marburg, 35043

  • LMU Klinikum

    München, 81377

  • TUM Klinikum

    München, 81675

  • Universitätsklinikum Münster

    Münster, 48149

  • Klinikum Nürnberg

    Nuremberg, 90419

  • St. Theresien Krankenhaus Nürnberg

    Nuremberg, 90491

  • Studienpraxis Urologie

    Nürtingen, 72622

  • Brüderkrankenhaus St- Josef Paderborn

    Paderborn, North Rhine-Westphalia, 33098

  • Urologische Klinik München Planegg

    Planegg, München, 82152

  • Brüderkrankenhaus

    Trier, 54292

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, 89081

  • Klinikum Wetzlar

    Wetzlar, Hesse, 35578

  • Praxisgemeinschaft f. Onkologie & Urologie

    Wilhelmshaven, Schleswig-Holstein, 26389

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, 42283

  • Urologisches Zentrum Euregio

    Würselen, North Rhine-Westphalia, 52146

  • Uniklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

Austria2 sites

  • Ordensklinikum Linz GmbH, Elisabethinen

    Linz, Austria, 4020

  • Krankenhaus der Barmherzigen Brüder

    Vienna, Austria, 1020

Other trials in Austria

About this study

Official title: A Randomised, Phase 3 Trial Comparing 3-weekly Docetaxel 75 mg/m2 (in a 3 Week Cycle) Versus 2-weekly Docetaxel 50 mg/m2 (in a 4 Week Cycle) in Combination With Darolutamide + ADT in Patients With mHSPC

The purpose of this clinical phase 3 randomized trial is to compare two different dosing schedules of Docetaxel in combination with ADT and Darolutamide in subjects with mHSPC. The main question aims to compare grade 3-5 adverse events (AEs) in patients with mHSPC treated with 6 cycles of either Docetaxel 75 mg/m2 every 3 weeks in a 3 week cycle or 6 cycles of Docetaxel 50 mg/m2 every 2 weeks in a 4 week cycle in combination with Darolutamide + ADT. The primary endpoint are Grade 3-5 AEs, followed by neutropenia grade 3/4 + grade 5 AEs to be analysed 28 weeks after last patient first Docetaxel dose (LPFD).

Read the detailed description

This is a randomized, open, controlled, multicenter phase III clinical trial. Approximately 250 patients with mHSPC who are candidates for docetaxel, darolutamide and ADT will be randomized (1:1 ratio) to one of the following study arms:

  • Arm 1: 6 x Docetaxel 75 mg/m2 every 3 weeks of a 3 week cycle
  • Arm 2: 6 x Docetaxel 50 mg/ m2 every 2 weeks of a 4 week cycle Subjects will be stratified at randomization for the extent of disease and for Alkaline Phosphatase levels.

All subjects must receive ADT of Investigator's choice (LHRH agonist/antagonists or orchiectomy) and darolutamide as standard therapy. Six cycles of docetaxel are be administered after randomization according to either Arm 1 or Arm 2. After completion of study drug treatment, subjects will continue with the observation period. During the observation period all subjects will continue with Darolutamide+ADT until occurrence of metastatic castration-resistant prostate cancer (mCRPC).

Being tested
Standard ADT (androgen deprivation therapy), Standard Darolutamide, Docetaxel
Keywords
prostate cancer, metastatic prostate cancer, metastatic hormone-sensitive prostate cancer, docetaxel, darolutamide, safety
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard ADT (androgen deprivation therapy)Drug

    as prescribed by the treating physician.

  • Standard DarolutamideDrug

    2x600 mg/d as prescribed by the treating physician

  • DocetaxelDrug

    Docetaxel

Study groups in NCT05676203
Study groupRoleWhat they receive
Arm 1Active comparator6 x Docetaxel 75 mg/m2 every 3 weeks of a 3 week cycle Co-administration of docetaxel, darolutamide and standard ADT
Receives: Drug: Standard ADT (androgen deprivation therapy); Drug: Standard Darolutamide; Drug: Docetaxel
Arm 2Experimental6 x Docetaxel 50 mg/ m2 every 2 weeks of a 4 week cycle Co-administration of docetaxel, darolutamide and standard ADT
Receives: Drug: Standard ADT (androgen deprivation therapy); Drug: Standard Darolutamide; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of grade 3-5 AEs

    Rate of grade 3-5 AEs, followed by rate of neutropenia grade 3/4 + grade 5 AEs t

    Measured: 28 weeks after last patient first Docetaxel dose (LPFD)

Secondary outcomes (9)

  1. PSA-response

    PSA-response (PSA <=0.2, >0.2-4.0 und >4.0 ng/ml) determined at week 28 after LPFD

    Measured: 28 after LPFD

  2. Time to castration-resistant prostate cancer

    approx. every 90 days, defined as the time to PSA progression with serum testosterone being at castrate level <0.50 ng/mL, or the time to progression by soft tissue/visceral lesions or time to progression by bone lesions whatever comes first;

    Measured: approximately 42 months

  3. Overall survival

    defined as the time (in days) from date of randomization until death from any cause

    Measured: approximately 42 months

  4. Time to initiation of subsequent antineoplastic therapy

    approx. every 90 days up to the date of first subsequent antineoplastic therapy for prostate cancer

    Measured: approximately 42 months

  5. Symptomatic skeletal event free survival (SSE)

    approx. every 90 days up to the first occurence of SSE, symptomatic skeletal event free survival, defined as the time from randomization to the first occurrence of SSE or death from any cause, whichever comes first. An SSE is defined as EBRT to relieve skeletal symptoms, or new symptomatic pathologic bone fracture, or occurrence of spinal cord compression or tumor-related orthopedic surgical intervention, whichever comes first.

    Measured: approximately 42 months

  6. Time to first symptomatic skeletal event (SSE)

    approx. every 90 days up to the first occurence of SSE, defined as the time from randomization to the first occurrence of SSE. An SSE is defined as EBRT to relieve skeletal symptoms, or new symptomatic pathologic bone fracture, or occurrence of spinal cord compression or tumor-related orthopedic surgical intervention, whichever comes first.

    Measured: approximately 42 months

  7. Time to pain progression

    approx. every 90 days up to the first date a subject experiences a pain progression. Pain to be assessed with a patient reported questionaire

    Measured: approximately 42 months

  8. Time to worsening of physical symptoms of disease

    approx. every 90 days up to the first date a subject experiences an increase in physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire

    Measured: approximately 42 months

  9. Treatment emergent adverse events

    all grade AEs until the end-of-study treatment visit (to be analysed 26 weeks after last patient first Docetaxel, all grade AEs until the discontinuation visit, all and Study drug-related SAEs until the end of Survival Follow-up

    Measured: approximately 42 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2023
  2. Study start16 May 2023
  3. Primary completion3 Jul 2025
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05676203
Sponsor's protocol ID
UTN-01-2022
Acronym
ARASAFE
Status last verified
Aug 2026
First submitted
14 Dec 2022
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Standard ADT (androgen deprivation therapy), Standard Darolutamide and Docetaxel in people with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), run by Jena University Hospital at 43 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of grade 3-5 AEs (time frame: 28 weeks after last patient first Docetaxel dose (LPFD)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05676203.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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