To hear about similar clinical trials, please enter your email below

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

NCT ID: NCT05676203

Condition: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Conditions: Official terms:
Prostatic Neoplasms
Hypersensitivity
Docetaxel
Androgens

Conditions: Keywords:
prostate cancer
metastatic prostate cancer
metastatic hormone-sensitive prostate cancer
docetaxel
darolutamide
safety

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Intervention:

Intervention type: Drug
Intervention name: Standard ADT (androgen deprivation therapy)
Description: as prescribed by the treating physician.
Arm group label: Arm 1
Arm group label: Arm 2

Intervention type: Drug
Intervention name: Standard Darolutamide
Description: 2x600 mg/d as prescribed by the treating physician
Arm group label: Arm 1
Arm group label: Arm 2

Intervention type: Drug
Intervention name: Docetaxel
Description: Docetaxel
Arm group label: Arm 1
Arm group label: Arm 2

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 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).

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).

Criteria for eligibility:
Criteria:
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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg

Address:
City: Heidelberg
Zip: 69120
Country: Germany

Status: Recruiting

Contact:
Last name: Christine Barbara Grün, Dr. med.

Contact backup:
Last name: Stefanie Zschäbitz, Dr. med.

Facility:
Name: Klinikum Wetzlar

Address:
City: Wetzlar
Zip: 35578
Country: Germany

Status: Active, not recruiting

Facility:
Name: Urologische Klinik München Planegg

Address:
City: Planegg
Zip: 82152
Country: Germany

Status: Active, not recruiting

Facility:
Name: Med. Hochschule Hannover

Address:
City: Hannover
Zip: 30625
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Philipp Ivanyi, PD Dr. med.

Contact backup:
Last name: Eggers Hendrik, Dr. med.

Facility:
Name: Urologicum Duisburg

Address:
City: Duisburg
Zip: 47169
Country: Germany

Status: Recruiting

Contact:
Last name: Eva Hellmis, Dr. med.

Contact backup:
Last name: Lena Rößing, Dr. med.

Facility:
Name: Brüderkrankenhaus St- Josef Paderborn

Address:
City: Paderborn
Zip: 33098
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Harald Müller-Huesmann, Dr. med.

Contact backup:
Last name: Tobias Gaska, Dr. med.

Facility:
Name: Urologisches Zentrum Euregio

Address:
City: Würselen
Zip: 52146
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Thomas Pulte, Dr. med.

Contact backup:
Last name: Stefan Wolter, Dr. med.

Facility:
Name: Krankenhaus Martha-Maria Halle Dölau gGmbH

Address:
City: Halle/Saale
Zip: 06120
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Florian Seseke, Prof. Dr.

Contact backup:
Last name: Juliane Künzel, Dr. med.

Facility:
Name: Praxisgemeinschaft f. Onkologie & Urologie

Address:
City: Wilhelmshaven
Zip: 26389
Country: Germany

Status: Active, not recruiting

Facility:
Name: University Hospital Jena, Department of Urology

Address:
City: Jena
Zip: 07747
Country: Germany

Status: Recruiting

Contact:
Last name: Marc-Oliver Grimm

Phone: 36419329900
Email: marc-oliver.grimm@med.uni-jena.de

Investigator:
Last name: Marc-Oliver Grimm, Prof. Dr.
Email: Principal Investigator

Facility:
Name: Marien Krankenhaus

Address:
City: Bergisch Gladbach
Zip: 51465
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Stefan Machtens, Dr.
Email: stefan.machtens@gfo-kliniken-rhein-berg.de

Facility:
Name: Vivantes Prostatazentrum im Klinikum am Urban

Address:
City: Berlin
Zip: 10967
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Jonas Busch, Prof. Dr. med.

Contact backup:
Last name: Ines Santiago, Dr. med.

Facility:
Name: Universitätsklinikum Bonn

Address:
City: Bonn
Zip: 53127
Country: Germany

Status: Active, not recruiting

Facility:
Name: Urologie Schlosscarree

Address:
City: Braunschweig
Zip: 38100
Country: Germany

Status: Recruiting

Contact:
Last name: Harald Junius, Dr.
Email: schreier@schlosscarree.de

Facility:
Name: Städtisches Klinikum Dessau

Address:
City: Dessau
Zip: 06847
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Diana Standhaft,, Dr.
Email: diana.standhaft@klinikum-dessau.de

Facility:
Name: Universitätsklinikum Düsseldorf

Address:
City: Düsseldorf
Zip: 40225
Country: Germany

Status: Recruiting

Contact:
Last name: Günther Niegisch, PD Dr.
Email: guenter.niegisch@med.uni-duesseldorf.de

Facility:
Name: Helios Klinikum Erfurt

Address:
City: Erfurt
Zip: 99089
Country: Germany

Status: Recruiting

Contact:
Last name: Thomas Steiner, Prof. Dr.
Email: thomas.steiner@helios-kliniken.de

Facility:
Name: Uniklinikum Erlangen

Address:
City: Erlangen
Zip: 91054
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Peter J. Goebell,, PD Dr.
Email: Peter.Goebell@uk-erlangen.de

Facility:
Name: KEM | Evang. Kliniken Essen-Mitte

Address:
City: Essen
Zip: 45136
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Susanne Krege, Prof. Dr.
Email: S.Krege@kem-med.com

Facility:
Name: Universitätsklinikum Essen

Address:
City: Essen
Zip: 45147
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Boris Hadaschik, Prof. Dr.
Email: Boris.Hadaschik@uk-essen.de

Facility:
Name: Krankenhaus Nordwest

Address:
City: Frankfurt am Main
Zip: 60488
Country: Germany

Status: Active, not recruiting

Facility:
Name: Universitäts Klinikum Frankfurt

Address:
City: Frankfurt am Main
Zip: 60590
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Severine Banek, Dr.
Email: severine.banek@kgu.de

Facility:
Name: Universitätsklinikum Giessen und Marburg GmbH, Standort Giessen

Address:
City: Giessen
Zip: 35392
Country: Germany

Status: Recruiting

Contact:
Last name: Florian Wagenlehner, Prof. Dr. med.

Contact backup:
Last name: Adrian Pilatz, Prof. Dr.

Facility:
Name: Universitätsklinikum Hamburg-Eppendorf

Address:
City: Hamburg
Country: Germany

Status: Recruiting

Contact:
Last name: Gunhild von Amsberg, Prof. Dr. med.
Email: g.von-amsberg@uke.de

Facility:
Name: St. Anna Hospital Herne

Address:
City: Herne
Zip: 44625
Country: Germany

Status: Recruiting

Contact:
Last name: Florian Roghmann, PD Dr.
Email: florian.roghmann@elisabethgruppe.de

Facility:
Name: UROLOGIE BAYENTHAL Gemeinschaftspraxis

Address:
City: Köln
Country: Germany

Status: Active, not recruiting

Facility:
Name: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Address:
City: Lübeck
Country: Germany

Status: Active, not recruiting

Facility:
Name: Universitätsklinikum Magdeburg

Address:
City: Magdeburg
Zip: 39120
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Martin Schostak,, Prof. Dr.
Email: investigator.schostak@med.ovgu.de

Facility:
Name: Universitätsmedizin Mannheim

Address:
City: Mannheim
Zip: 68167
Country: Germany

Status: Recruiting

Contact:
Last name: Frederik Wessels, PD Dr. med,
Email: frederik.wessels@medma.uni-heidelberg.de

Facility:
Name: Universitätsklinikum Gießen und Marburg - Standort Marburg

Address:
City: Marburg
Zip: 35043
Country: Germany

Status: Recruiting

Contact:
Last name: Hendrik Heers, Dr.
Email: Hendrik.Heers@med.uni-marburg.de

Facility:
Name: LMU Klinikum

Address:
City: München
Zip: 81377
Country: Germany

Status: Recruiting

Contact:
Last name: Jozefina Casuscelli, Dr.
Email: Jozefina.Casuscelli@med.uni-muenchen.de

Facility:
Name: TUM Klinikum

Address:
City: München
Zip: 81675
Country: Germany

Status: Recruiting

Contact:
Last name: Margitta Retz, Prof. Dr.
Email: margitta.retz@tum.de

Facility:
Name: Universitätsklinikum Münster

Address:
City: Münster
Zip: 48149
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Martin Bögemann, PD Dr.
Email: martin.boegemann@ukmuenster.de

Facility:
Name: Klinikum Nürnberg

Address:
City: Nürnberg
Zip: 90419
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Marinela Augustin,, Dr.
Email: Marinela.Augustin@klinikum-nuernberg.de

Facility:
Name: St. Theresien Krankenhaus Nürnberg

Address:
City: Nürnberg
Zip: 90491
Country: Germany

Status: Recruiting

Contact:
Last name: Bernd Schmitz-Dräger, Prof. Dr.
Email: b.schmitz-draeger@urologie24.de

Facility:
Name: Studienpraxis Urologie

Address:
City: Nürtingen
Zip: 72622
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Tilman Todenhöfer,, Prof. Dr.
Email: todenhoefer@studienurologie.de

Facility:
Name: Brüderkrankenhaus

Address:
City: Trier
Zip: 54292
Country: Germany

Status: Recruiting

Contact:
Last name: Andreas Neisius,, PD Dr.
Email: A.Neisius@bk-trier.de

Facility:
Name: Universitätsklinikum Tübingen

Address:
City: Tuebingen
Zip: 72076
Country: Germany

Status: Recruiting

Contact:
Last name: Steffen Rausch, Prof. Dr.

Contact backup:
Email: steffen.rausch@med.uni-tuebingen.de

Facility:
Name: Universitätsklinikum Ulm

Address:
City: Ulm
Zip: 89081
Country: Germany

Status: Recruiting

Contact:
Last name: Friedemann Zengerling, Dr.
Email: friedemann.zengerling@uniklinik-ulm.de

Facility:
Name: Helios Universitätsklinikum Wuppertal

Address:
City: Wuppertal
Zip: 42283
Country: Germany

Status: Recruiting

Contact:
Last name: Stephan Degener, MD
Email: stephan.degener@helios-gesundheit.de

Facility:
Name: Helios Universitätsklinikum Wuppertal

Address:
City: Wuppertal
Zip: 42283
Country: Germany

Status: Recruiting

Contact:
Last name: Friedrich von Rundstedt, Prof. Dr.
Email: Friedrich.vonRundstedt@helios-gesundheit.de

Facility:
Name: Uniklinikum Würzburg

Address:
City: Würzburg
Zip: 97080
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Anna Katharina Seitz,, Dr.
Email: Seitz_A2h@ukw.de

Start date: May 16, 2023

Completion date: August 2026

Lead sponsor:
Agency: Jena University Hospital
Agency class: Other

Collaborator:
Agency: Bayer
Agency class: Industry

Source: Jena University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05676203

Login to your account

Did you forget your password?