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Can a new chemo schedule tame side effects in prostate cancer?

NCT ID NCT05676203

Disease control Sponsor: Jena University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether giving the chemotherapy drug docetaxel more often but at a lower dose—every 2 weeks instead of every 3 weeks—can reduce severe side effects in men with metastatic hormone-sensitive prostate cancer. All participants also receive the standard combination of darolutamide and hormone therapy. The study tracks how many men experience serious side effects, as well as PSA levels and time until the cancer becomes resistant to hormone therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Docetaxel (chemotherapy) given in two different schedules, combined with darolutamide and androgen deprivation therapy (ADT)
What this could lead to
If successful, this could identify a safer chemotherapy schedule that reduces severe side effects while maintaining effectiveness for men with metastatic prostate cancer.
What could go wrong
The trial is still in progress, and results may not show a clear difference between schedules. Chemotherapy can cause serious side effects like infections and nerve damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

250 people

The number who actually took part.

Started

May 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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. Exclusion Criteria: * Exclusion criteria * 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 * 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

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic hormone-sensitive prostate cancer (MHSPC)

Contacts and locations

Locations

  • Brüderkrankenhaus

    Trier, 54292, Germany

  • Brüderkrankenhaus St- Josef Paderborn

    Paderborn, North Rhine-Westphalia, 33098, Germany

  • Helios Klinikum Erfurt

    Erfurt, 99089, Germany

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, 42283, Germany

  • KEM | Evang. Kliniken Essen-Mitte

    Essen, 45136, Germany

  • Klinikum Nürnberg

    Nuremberg, 90419, Germany

  • Klinikum Wetzlar

    Wetzlar, Hesse, 35578, Germany

  • Krankenhaus Martha-Maria Halle Dölau gGmbH

    Halle, Saxony-Anhalt, 06120, Germany

  • Krankenhaus Nordwest

    Frankfurt am Main, 60488, Germany

  • Krankenhaus der Barmherzigen Brüder

    Vienna, Austria, 1020, Austria

  • LMU Klinikum

    München, 81377, Germany

  • Marien Krankenhaus

    Bergisch Gladbach, 51465, Germany

  • Med. Hochschule Hannover

    Hanover, Lower Saxony, 30625, Germany

  • Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Ordensklinikum Linz GmbH, Elisabethinen

    Linz, Austria, 4020, Austria

  • Praxisgemeinschaft f. Onkologie & Urologie

    Wilhelmshaven, Schleswig-Holstein, 26389, Germany

  • St. Anna Hospital Herne

    Herne, 44625, Germany

  • St. Theresien Krankenhaus Nürnberg

    Nuremberg, 90491, Germany

  • Studienpraxis Urologie

    Nürtingen, 72622, Germany

  • Städtisches Klinikum Dessau

    Dessau, 06847, Germany

  • TUM Klinikum

    München, 81675, Germany

  • UROLOGIE BAYENTHAL Gemeinschaftspraxis

    Cologne, Germany

  • Uniklinikum Erlangen

    Erlangen, 91054, Germany

  • Uniklinikum Würzburg

    Würzburg, 97080, Germany

  • University Hospital Jena, Department of Urology

    Jena, Thuringia, 07747, Germany

  • Universitäts Klinikum Frankfurt

    Frankfurt am Main, 60590, Germany

  • Universitätsklinikum Bonn

    Bonn, 53127, Germany

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Essen

    Essen, 45147, Germany

  • Universitätsklinikum Giessen und Marburg GmbH, Standort Giessen

    Giessen, 35392, Germany

  • Universitätsklinikum Gießen und Marburg - Standort Marburg

    Marburg, 35043, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Germany

  • Universitätsklinikum Magdeburg

    Magdeburg, 39120, Germany

  • Universitätsklinikum Münster

    Münster, 48149, Germany

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    Lübeck, Germany

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Universitätsmedizin Mannheim

    Mannheim, 68167, Germany

  • Urologicum Duisburg

    Duisburg, North Rhine-Westphalia, 47169, Germany

  • Urologie Schlosscarree

    Braunschweig, 38100, Germany

  • Urologische Klinik München Planegg

    Planegg, München, 82152, Germany

  • Urologisches Zentrum Euregio

    Würselen, North Rhine-Westphalia, 52146, Germany

  • Vivantes Prostatazentrum im Klinikum am Urban

    Berlin, State of Berlin, 10967, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.