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
