Study Comparing Docetaxel, Darolutamide, and ADT for Patients with Metastatic Hormone-Sensitive Prostate Cancer

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What is this study about?

This clinical trial is focused on studying treatments for metastatic hormone-sensitive prostate cancer, a type of cancer that has spread beyond the prostate gland but still responds to hormone therapy. The study involves comparing two different dosing schedules of a chemotherapy drug called docetaxel. One group of patients will receive docetaxel at a dose of 75 mg per square meter of body surface area every three weeks, while another group will receive 50 mg per square meter every two weeks. Both groups will also receive a medication called darolutamide and a type of hormone therapy known as androgen deprivation therapy (ADT), which reduces levels of male hormones that can promote cancer growth.

The purpose of the study is to compare the safety of these treatment regimens by looking at the occurrence of serious side effects. The study will also monitor for a specific side effect called neutropenia, which is a low level of white blood cells that can increase the risk of infection. Patients will undergo six cycles of treatment, and the study will track their health and any side effects they experience during this time. The trial will also assess other outcomes, such as overall survival, the time it takes for the cancer to become resistant to hormone therapy, and the quality of life of the participants.

Participants in the study will receive their treatments either as an intravenous infusion, which is a method of delivering medication directly into the bloodstream, or as oral tablets. The study aims to provide valuable information on the best way to use docetaxel in combination with darolutamide and ADT for treating this type of prostate cancer. The results could help improve treatment strategies and outcomes for patients with this condition.

1 joining the trial

Upon joining the trial, consent is required. This involves understanding the trial’s purpose, procedures, and potential risks and benefits.

Eligibility is confirmed through specific criteria, including age, medical history, and current health status.

2 initial assessment

An initial assessment is conducted to gather baseline health information. This may include blood tests, imaging scans, and other diagnostic procedures.

The assessment helps determine the current state of the prostate cancer and ensures all criteria for participation are met.

3 treatment phase

The treatment phase involves receiving medications. Docetaxel is administered either every 3 weeks at 75 mg/m² or every 2 weeks at 50 mg/m², depending on the assigned group.

Darolutamide is taken orally as part of the treatment regimen. The dosage and frequency are determined by the study protocol.

Additional medications, such as ADT (androgen deprivation therapy), may be part of the treatment plan.

4 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment and manage any side effects. This includes blood tests, imaging, and other evaluations.

Follow-up visits are scheduled to track progress and make any necessary adjustments to the treatment plan.

5 end of treatment

At the end of the treatment phase, a final assessment is conducted to evaluate the overall response to the therapy.

Long-term follow-up may be required to monitor health status and any delayed effects of the treatment.

Who Can Join the Study?

  • Must provide written informed consent, which means you agree to participate in the study after being informed about all aspects of the trial.
  • Blood tests must show certain levels: serum alanine aminotransferase and/or aspartate transaminase should be no more than 1.5 times the normal limit, total bilirubin should be within the normal limit, and creatinine should be no more than 2 times the normal limit.
  • If sexually active, male participants must agree to use condoms and not donate sperm during the study and for a period after the study. Female partners should use effective birth control during this time.
  • Must be a male aged 18 years or older.
  • Must have a confirmed diagnosis of adenocarcinoma of the prostate, which is a type of prostate cancer.
  • Must have metastatic disease, meaning the cancer has spread to other parts of the body, confirmed by specific scans like a bone scan, CT, or MRI.
  • Participants with only lymph node metastases in certain areas will not be eligible.
  • Must be suitable for treatment with ADT (Androgen Deprivation Therapy), docetaxel, and darolutamide as judged by the study doctor.
  • Must have started ADT treatment no more than 12 weeks before joining the study. If using LHRH agonists, it is recommended to have used them with a first-generation anti-androgen for at least 4 weeks before joining, but the anti-androgen must be stopped before joining.
  • Must have an Eastern Cooperative Oncology Group performance status of 0 or 1, which indicates you are fully active or have some symptoms but do not require bed rest.
  • Blood counts must meet certain levels: hemoglobin of at least 9.0 g/dL, absolute neutrophil count of at least 1.5×109/L, and platelet count of at least 100×109/L. You must not have received any growth factor treatment within 4 weeks or a blood transfusion within 7 days before the blood test.

Who Cannot Join the Study?

  • Patients who do not have prostate cancer cannot participate.
  • Only male patients are eligible for the study.
  • Patients who are part of a vulnerable population are not eligible. This means groups that might need special protection, like children or people who cannot make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Jena KöR Jena Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Medical University Of Graz Graz Austria

Other Sites

Site Name City Country Status
Philipps-Universitaet Marburg Marburg Germany
Helios Universitaetsklinikum Wuppertal Wuppertal Germany
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Martha-Maria Krankenhaus Halle-Doelau gGmbH Halle (Saale) Germany
Krankenhaus Der Barmherzigen Brueder Wien Vienna Austria
Lahn-Dill-Kliniken GmbH Wetzlar Germany
Krankenhaus Nordwest GmbH Frankfurt Germany
Klinikum Nuernberg Nürnberg Germany
Urologicum Duisburg Duisburg Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH Paderborn Germany
Justus-Liebig-Universitaet Giessen Giessen Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Barmherzige Brueder Trier gGmbH Trier Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
St. Marien-Krankenhaus GmbH Bergisch Gladbach Germany
HELIOS Klinikum Erfurt GmbH Erfurt Germany
Staedtisches Klinikum Dessau Dessau-Roßlau Germany
Heidelberg University Mannheim Germany
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Nuertingen Germany
Westfaelische Wilhelms Universitaet Muenster Munster Germany
Ogiohrjtsumbvt Lhxy Gtyc Linz Austria
Uapnldpr iy Sfqzqoomzcybv Brunswick Germany
Urxsjuozasl Keetjv Mxdcuswqbggxzvk Planegg Germany
Mvxaft Hrbkgigq Hlgex Uywhzkzwmipxzbvgcltv dbi Rgsbwlemrophvvsg Badvow Herne Germany
Ussdvkmdhrjzpnzhroweh Dwhegtpceax Apm Duesseldorf Germany
Gzvwgp Uestggbuez Fqudqkajt Frankfurt Germany
Kpwjrgmg dsd Uvinjnftcwmf Mmakpdgd Aij Munich Germany
Uuscpfhguljxpygdgqvco Womfzygoh Aeo Wuerzburg Germany
Uhbbaxvwnw Mbxdnlg Ckiehh Hqeijsryxejijiijx Hamburg Germany
Ungvdlbuqntahyaeaageo Egzht Afv Essen Germany
Kmapjsol Erzmdqzepcmmiqwtquhzfouz Hecbvjosestkdnrdn Essen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
03.04.2023
Germany Germany
Not recruiting
03.04.2023

Trial locations

Docetaxel is a type of chemotherapy medication used in this trial to treat prostate cancer. It works by stopping cancer cells from growing and dividing, which can help slow down or stop the spread of the disease. In this study, Docetaxel is given to patients in different schedules to see which one is more effective and has fewer side effects.

Darolutamide is a medication used to treat prostate cancer by blocking the effects of male hormones that can promote the growth of cancer cells. It is used in combination with other treatments to help manage the disease and improve patient outcomes.

ADT, or Androgen Deprivation Therapy, is a treatment that reduces the levels of male hormones in the body. These hormones can help prostate cancer cells grow, so lowering their levels can slow down the progression of the disease. ADT is often used alongside other treatments to enhance their effectiveness.

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often begins with small changes in the size and shape of prostate cells, which can develop into a tumor. As the disease progresses, it may spread to nearby tissues or other parts of the body, such as the bones or lymph nodes. The progression can lead to symptoms like difficulty urinating, blood in the urine, or pelvic discomfort. Over time, prostate cancer can become resistant to hormonal therapy, a stage known as castration-resistant prostate cancer. The disease’s progression is monitored through various markers, including prostate-specific antigen (PSA) levels.

Trial ID:
2022-502634-52-00
Protocol code:
UTN-01-2022
NCT ID:
NCT05676203
Trial Phase:
Therapeutic confirmatory (Phase III)

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