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JOURNAL ONKOLOGIE – STUDIE
ARASAFE

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

Rekrutierend

NCT-Nummer:
NCT05676203

Studienbeginn:
Mai 2023

Letztes Update:
29.02.2024

Wirkstoff:
Standard ADT (androgen deprivation therapy), Standard Darolutamide, Docetaxel

Indikation (Clinical Trials):
Prostatic Neoplasms, Hypersensitivity

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Jena University Hospital

Collaborator:
Bayer

Kontakt

Studienlocations
(3 von 42)

Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Christine Barbara Grün, Dr. med.

Stefanie Zschäbitz, Dr. med.» Ansprechpartner anzeigen
Klinikum Wetzlar
35578 Wetzlar
(Hessen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Urologische Klinik München Planegg
82152 Planegg
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Brüderkrankenhaus St- Josef Paderborn
33098 Paderborn
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Harald Müller-Huesmann, Dr. med.

Tobias Gaska, Dr. med.» Ansprechpartner anzeigen
Krankenhaus Martha-Maria Halle Dölau gGmbH
06120 Halle/Saale
(Sachsen-Anhalt)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Florian Seseke, Prof. Dr.

Juliane Künzel, Dr. med.» Ansprechpartner anzeigen
Praxisgemeinschaft f. Onkologie & Urologie
26389 Wilhelmshaven
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
University Hospital Jena, Department of Urology
07747 Jena
(Thüringen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Marc-Oliver Grimm
Phone: 36419329900
E-Mail: marc-oliver.grimm@med.uni-jena.de» Ansprechpartner anzeigen
Marien Krankenhaus
51465 Bergisch Gladbach
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Stefan Machtens, Dr.
E-Mail: stefan.machtens@gfo-kliniken-rhein-berg.de» Ansprechpartner anzeigen
Universitätsklinikum Bonn
53127 Bonn
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Darmkrebszentrum Universitätsklinikum Düsseldorf
Moorenstraße 5
40225 Düsseldorf
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Günther Niegisch, PD Dr.
E-Mail: guenter.niegisch@med.uni-duesseldorf.de» Ansprechpartner anzeigen
Lungenkrebszentrum Helios Klinikum Erfurt
Nordhäuser Straße 74
99089 Erfurt
(Thüringen)
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Thomas Steiner, Prof. Dr.
E-Mail: thomas.steiner@helios-kliniken.de» Ansprechpartner anzeigen
Kinderonkologisches Zentrum Universitätsklinikum Essen
Hufelandstraße 55
45147 Essen
DeutschlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Boris Hadaschik, Prof. Dr.
E-Mail: Boris.Hadaschik@uk-essen.de» Ansprechpartner anzeigen
Onkologisches Zentrum Krankenhaus Nordwest
Steinbacher Hohl 2-26
60488 Frankfurt am Main
DeutschlandAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Giessen und Marburg GmbH, Standort Giessen
35392 Giessen
(Hessen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Florian Wagenlehner, Prof. Dr. med.

Adrian Pilatz, Prof. Dr.» Ansprechpartner anzeigen
Brustzentrum am Universitätsklinikum Hamburg-Eppendorf
Martinistraße 52
20251 Hamburg
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Gunhild von Amsberg, Prof. Dr. med.
E-Mail: g.von-amsberg@uke.de» Ansprechpartner anzeigen
Darmkrebszentrum St. Anna Hospital Herne
Hospitalstraße 19
44649 Herne, Stadt
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Florian Roghmann, PD Dr.
E-Mail: florian.roghmann@elisabethgruppe.de» Ansprechpartner anzeigen
UROLOGIE BAYENTHAL Gemeinschaftspraxis
Köln
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck
(Schleswig-Holstein)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Magdeburg
39120 Magdeburg
(Sachsen-Anhalt)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Martin Schostak,, Prof. Dr.
E-Mail: investigator.schostak@med.ovgu.de» Ansprechpartner anzeigen
Kopf-Hals-Tumorzentrum der Universitätsmedizin Mannheim
68167 Mannheim
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Frederik Wessels, PD Dr. med,
E-Mail: frederik.wessels@medma.uni-heidelberg.de» Ansprechpartner anzeigen
Universitätsklinikum Gießen und Marburg - Standort Marburg
35043 Marburg
(Hessen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Hendrik Heers, Dr.
E-Mail: Hendrik.Heers@med.uni-marburg.de» Ansprechpartner anzeigen
Kinderonkologisches Zentrum am Universitätsklinikum Münster
Albert-Schweitzer-Campus 1
48149 Münster
DeutschlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Martin Bögemann, PD Dr.
E-Mail: martin.boegemann@ukmuenster.de» Ansprechpartner anzeigen
Interdisziplinäres Brustzentrum Klinikum Nürnberg
Prof.-Ernst-Nathan-Straße 1
90419 Nürnberg
(Bayern)
DeutschlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Marinela Augustin,, Dr.
E-Mail: Marinela.Augustin@klinikum-nuernberg.de» Ansprechpartner anzeigen
Studienpraxis Urologie
72622 Nürtingen
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Tilman Todenhöfer,, Prof. Dr.
E-Mail: todenhoefer@studienurologie.de» Ansprechpartner anzeigen
Darmkrebszentrum im Brüderkrankenhaus St. Josef Paderborn
Husener Straße 46
33098 Paderborn
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Andreas Neisius,, PD Dr.
E-Mail: A.Neisius@bk-trier.de» Ansprechpartner anzeigen
Viszeralonkologisches Zentrum Universitätsklinikum Tübingen
Hoppe-Seyler-Straße 3
72076 Tübingen
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Steffen Rausch, Prof. Dr.


E-Mail: steffen.rausch@med.uni-tuebingen.de» Ansprechpartner anzeigen
Leberkrebszentrum Universitätsklinikum Ulm
Albert-Einstein-Allee 23
89081 Ulm
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Friedemann Zengerling, Dr.
E-Mail: friedemann.zengerling@uniklinik-ulm.de» Ansprechpartner anzeigen
Helios Universitätsklinikum Wuppertal
42283 Wuppertal
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Stephan Degener, MD
E-Mail: stephan.degener@helios-gesundheit.de» Ansprechpartner anzeigen
Helios Universitätsklinikum Wuppertal
42283 Wuppertal
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Friedrich von Rundstedt, Prof. Dr.
E-Mail: Friedrich.vonRundstedt@helios-gesundheit.de» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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).

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Rate of grade 3-5 AEs (Time Frame - 28 weeks after last patient first Docetaxel dose (LPFD)):
Rate of grade 3-5 AEs, followed by rate of neutropenia grade 3/4 + grade 5 AEs t



Secondary outcome:

1. PSA-response (Time Frame - 28 after LPFD):
PSA-response (PSA <=0.2, >0.2-4.0 und >4.0 ng/ml) determined at week 28 after LPFD

2. Time to castration-resistant prostate cancer (Time Frame - approximately 42 months):
approx. every 90 days, defined as the time to PSA progression with serum testosterone being at castrate level <0.50 ng/mL, or the time to progression by soft tissue/visceral lesions or time to progression by bone lesions whatever comes first;

3. Overall survival (Time Frame - approximately 42 months):
defined as the time (in days) from date of randomization until death from any cause

4. Time to initiation of subsequent antineoplastic therapy (Time Frame - approximately 42 months):
approx. every 90 days up to the date of first subsequent antineoplastic therapy for prostate cancer

5. Symptomatic skeletal event free survival (SSE) (Time Frame - approximately 42 months):
approx. every 90 days up to the first occurence of SSE, symptomatic skeletal event free survival, defined as the time from randomization to the first occurrence of SSE or death from any cause, whichever comes first. An SSE is defined as EBRT to relieve skeletal symptoms, or new symptomatic pathologic bone fracture, or occurrence of spinal cord compression or tumor-related orthopedic surgical intervention, whichever comes first.

6. Time to first symptomatic skeletal event (SSE) (Time Frame - approximately 42 months):
approx. every 90 days up to the first occurence of SSE, defined as the time from randomization to the first occurrence of SSE. An SSE is defined as EBRT to relieve skeletal symptoms, or new symptomatic pathologic bone fracture, or occurrence of spinal cord compression or tumor-related orthopedic surgical intervention, whichever comes first.

7. Time to pain progression (Time Frame - approximately 42 months):
approx. every 90 days up to the first date a subject experiences a pain progression. Pain to be assessed with a patient reported questionaire

8. Time to worsening of physical symptoms of disease (Time Frame - approximately 42 months):
approx. every 90 days up to the first date a subject experiences an increase in physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire

9. Treatment emergent adverse events (Time Frame - approximately 42 months):
all grade AEs until the end-of-study treatment visit (to be analysed 26 weeks after last patient first Docetaxel, all grade AEs until the discontinuation visit, all and Study drug-related SAEs until the end of Survival Follow-up

Studien-Arme

  • Active Comparator: Arm 1
    6 x Docetaxel 75 mg/m2 every 3 weeks of a 3 week cycle Co-administration of docetaxel, darolutamide and standard ADT
  • Experimental: Arm 2
    6 x Docetaxel 50 mg/ m2 every 2 weeks of a 4 week cycle Co-administration of docetaxel, darolutamide and standard ADT

Geprüfte Regime

  • Standard ADT (androgen deprivation therapy):
    as prescribed by the treating physician.
  • Standard Darolutamide:
    2x600 mg/d as prescribed by the treating physician
  • Docetaxel:
    Docetaxel

Quelle: ClinicalTrials.gov


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