Study on the Effects of Darolutamide and Drug Combination for Patients with Metastatic Hormone-Naïve Prostate Cancer

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What is this study about?

This clinical trial is focused on studying treatments for metastatic hormone-naïve prostate cancer, a type of prostate cancer that has spread to other parts of the body but has not yet been treated with hormone therapy. The study will explore the effects of different medications, including darolutamide (also known as ODM-201 or BAY 1841788), goserelin acetate, leuprorelin acetate (also known as leuprolide acetate), apalutamide (also known as ARN-509), relugolix (also known as TAK-385), degarelix, enzalutamide (also known as MDV3100), abiraterone, and triptorelin acetate. These medications are used in hormone therapy to manage prostate cancer by blocking or reducing the effects of male hormones that can promote cancer growth.

The purpose of the study is to compare two approaches to hormone therapy: intermittent maximum androgen blockade (iMAB) and continuous maximum androgen blockade (cMAB). The study aims to determine the benefits and risks of these approaches in patients who have shown a significant response to initial hormone therapy. Participants will be randomly assigned to either continue their hormone therapy without interruption or to have breaks in their treatment. The study will monitor how long patients can go without restarting hormone therapy and compare the overall survival rates between the two groups.

Throughout the study, participants will be observed for changes in their quality of life, including physical functioning, sexual activity, and pain levels. The study will also track the time it takes for patients to need additional prostate cancer treatments and monitor their testosterone and PSA (prostate-specific antigen) levels. The trial will help determine if taking breaks in hormone therapy can maintain the same level of cancer control as continuous treatment while potentially improving the quality of life for patients.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups: the **intermittent maximum androgen blockade (iMAB)** group or the **continuous maximum androgen blockade (cMAB)** group.

This assignment will determine the course of your treatment during the trial.

2 treatment phase

If you are in the **iMAB** group, your treatment will be paused after achieving a deep response, defined as a **PSA level** of 0.2 ng/mL or lower, for a period of up to one year.

If you are in the **cMAB** group, you will continue receiving treatment without interruption.

The medications used in this trial may include **darolutamide**, **goserelin acetate**, **leuprorelin acetate**, **apalutamide**, **relugolix**, **enzalutamide**, **abiraterone**, and **triptorelin acetate**. These medications are administered either orally or through injections.

3 monitoring and assessments

Throughout the trial, regular assessments will be conducted to monitor your health and the effectiveness of the treatment.

These assessments will include measuring your **PSA levels**, checking your testosterone levels, and evaluating your overall health and quality of life.

You will be asked to complete questionnaires about your physical functioning, sexual activity, pain, and fatigue.

4 end of treatment evaluation

At the end of the treatment phase, a comprehensive evaluation will be conducted to assess the outcomes of the trial.

This evaluation will include a review of your **PSA levels**, testosterone levels, and overall survival.

The results will help determine the effectiveness and safety of the intermittent treatment approach compared to continuous treatment.

5 follow-up

After the treatment phase, follow-up assessments will continue for up to three years to monitor long-term effects and outcomes.

These follow-ups will include regular health check-ups and assessments of your quality of life.

The information gathered during this period will contribute to understanding the long-term benefits and risks of the treatment strategies.

Who Can Join the Study?

  • Must be a male patient.
  • Must have metastatic hormone-naïve prostate cancer (mHNPC). This means the prostate cancer has spread to other parts of the body but has not been treated with hormone therapy before.
  • Must have been treated with ADT (Androgen Deprivation Therapy) for 6 to 12 months. ADT is a treatment that reduces male hormones to slow the growth of cancer.
  • Must have been treated with an ARpI (Androgen Receptor Pathway Inhibitor) for 6 to 12 months. ARpI is a medication that blocks the action of male hormones.
  • Must have a PSA level of ≤ 0.2 ng/mL. PSA (Prostate-Specific Antigen) is a protein produced by the prostate, and its level is used to monitor prostate cancer.
  • Can have either synchronous (at the same time) or metachronous (at different times) metastases, which means the cancer has spread to other parts of the body.
  • Can have either high volume or low volume/risk cancer, which refers to the amount and severity of cancer spread.
  • Must provide written informed consent before joining the study. This means agreeing to participate after understanding the study details.

Who Cannot Join the Study?

  • Patients with metastatic hormone-naïve prostate cancer (mHNPC) cannot participate. This means the cancer has spread to other parts of the body, but the patient has not yet received hormone therapy.
  • Only male patients are eligible for this study.
  • Patients who are part of a vulnerable population are not eligible. This generally refers to groups who may have limited ability to give informed consent or are at higher risk of being exploited.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Hospital Universitario De Navarra Pamplona Spain
Centre Jean Perrin Clermont Ferrand France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Klinički bolnički centar Zagreb (University Hospital Center Zagreb) Zagreb Croatia
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Katholieke Universiteit te Leuven Leuven Belgium
Comite Entreprise Paul Papin Angers France
Azienda Ospedaliero Universitaria Careggi Florence Italy
Institut Curie – Site Paris Paris France
Medisprof S.R.L. Cluj Napoca Romania

Other Sites

Site Name City Country Status
Centre Hospitalier De Colmar Colmar France
Institut Jules Bordet Anderlecht Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
University Hospital Limerick Limerick Ireland
Hospital San Pedro De Alcantara Caceres Spain
Grand Hopital De Charleroi Charleroi Belgium
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble Grenoble France
Hospital Clinico Universitario De Valladolid Valladolid Spain
Clinique Pasteur Lanroze Brest France
Institut Godinot Reims France
Capio La Croix Du Sud Quint-Fonsegrives France
Virgen del Rocío University Hospital Sevilla Spain
Centre Hospitalier Universitaire d’Orléans Orléans France
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Brno Brno Czechia
Hospital Universitario De Cruces Barakaldo Spain
University Hospital Galway Galway Ireland
Centre Hospitalier De La Cote Basque Bayonne France
Hospital Universitario Lucus Augusti Lugo Spain
St Vincent’s University Hospital Dublin Ireland
Centre Medico Chirurgical Ambroise Pare Hartmann Neuilly-Sur-Seine France
University Hospital Olomouc Olomouc Czechia
Rigshospitalet Copenhagen Denmark
CHU Helora La Louviere Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Servei De Salut De Les Illes Balears Palma Spain
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Beaumont Hospital Dublin Ireland
Centre Francois Baclesse Caen France
L’Hopital Prive Du Confluent Nantes France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Beacon Hospital Dublin Ireland
Mater Private Hospital Dublin Ireland
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A. Peschiera Del Garda Italy
Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola Rome Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Santa Maria Della Misericordia Perugia Italy
Ospedale Mater Salutis Di Legnago Legnago Italy
Hospital Universitario Virgen De La Victoria Malaga Spain
University Medical Center Ljubljana Ljubljana Slovenia
Oncomed S.R.L. Timisoara Romania
Chaiysvgf Ulkkaueczzllsv Spkxloezy Woluwe-Saint-Lambert Belgium
Imvixyib Ridifplq Du Czwnac Dr Mjizoudyeyt Montpellier France
Hjulobwgmqaavxinlurr Lvxa Lier Belgium
Ckmwmm Lrhk Byvwao Lyon France
Hwocssym Ucskenkoamemn Dm Ld Pfllnzsc Madrid Spain
Hirooatm Uhilsapwzgccp Mkrxolr Dw Vwibjmsmcn Santander Spain
Cdih Uyaqjaczct Hrmlbtxz Cork Ireland
Ioalgehz Cheddi Drmndgkkkynwzjhge L'hospitalet De Llobregat Spain
Iauqkmpk Mtjqbfrhcy Mxisdhsyfn Paris France
Pabj Twcii Hbgvssjn Uymgwxtobzod Sabadell Spain
Cbkkmz dj Rzvldxgvytcob &nsyugb Cjotvlsn Swekkg Auth STRASBOURG, Alsace France
Htvdjf Hbymaymj Herlev Denmark
Cfnekn Hpusexwwauk Rpqwsfiw Unrhsryqqgirv Dk Toutx Tours France
Htvmfmyi Do Lx Sbymi Clun I Szvk Pui Barcelona Spain
Gybnqn Hhkiookbhii Usirslqdjocsr Pzkgx Pkuiecxxqsu El Nomcskkkjsye Paris France
Ivsylgyw Pkbkxrnpxicqxjr Cljipz Cbltmb Marseille France
Cnhbxr Ofnmv Lsttahz Lille France
Irpdvf Iauaacyg Fvciqxraklqxi Omafnsotjnw Rome Italy
Houytdsx Ueenqyxvxjfkhr Sleqixxsin &pfipym Hmoidhx dm Howcfrjqebt STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.04.2025
Croatia Croatia
Recruiting
01.04.2025
Czechia Czechia
Not yet recruiting
01.04.2025
Denmark Denmark
Recruiting
01.04.2025
France France
Recruiting
01.04.2025
Ireland Ireland
Recruiting
01.04.2025
Italy Italy
Not yet recruiting
01.04.2025
Romania Romania
Not yet recruiting
01.04.2025
Slovenia Slovenia
Not yet recruiting
01.04.2025
Spain Spain
Recruiting
01.04.2025

Trial locations

Androgen Deprivation Therapy (ADT) is a treatment used to lower the levels of male hormones, such as testosterone, in the body. These hormones can help prostate cancer cells grow, so reducing their levels can slow down or stop the growth of the cancer. In this trial, ADT is used to help manage prostate cancer by reducing hormone levels.

Androgen Receptor Pathway Inhibitors (ARpI) are medications that block the action of male hormones on prostate cancer cells. These inhibitors prevent the hormones from attaching to the receptors on the cancer cells, which can stop the cells from growing and dividing. In this trial, ARpIs are used alongside ADT to enhance the treatment’s effectiveness in controlling prostate cancer.

Metastatic hormone-naïve prostate cancer – This is a type of prostate cancer that has spread beyond the prostate gland to other parts of the body, such as bones or lymph nodes, but has not yet been treated with hormone therapy. The disease progresses as cancer cells grow and multiply, forming new tumors in other areas. Initially, the cancer cells are sensitive to hormones, particularly testosterone, which fuels their growth. Over time, the cancer may become more aggressive and less responsive to hormonal signals. As the disease advances, symptoms such as bone pain, urinary issues, and fatigue may develop. The progression can vary widely among individuals, with some experiencing rapid changes and others having a slower course.

Trial ID:
2023-506817-23-01
Protocol code:
EORTC-2238-GUCG
NCT ID:
NCT05974774
Trial Phase:
Therapeutic confirmatory (Phase III)

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