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Docetaxel

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6 x Docetaxel 75 mg/m2 every 3 weeks of a 3 week cycle Co-administration of docetaxel, darolutamide and standard ADT

6 x Docetaxel 50 mg/ m2 every 2 weeks of a 4 week cycle Co-administration of docetaxel, darolutamide and standard ADT

Standard ADT (androgen deprivation therapy)

2x600 mg/d as prescribed by the treating physician

Standard Darolutamide

Marc-Oliver Grimm, Prof.

Andrea Roessler, PhD

Christine Barbara Grün, Dr. med.

Stefanie Zschäbitz, Dr. med.

Philipp Ivanyi, PD Dr. med.

Eggers Hendrik, Dr. med.

Eva Hellmis, Dr. med.

Lena Rößing, Dr. med.

Harald Müller-Huesmann, Dr. med.

Tobias Gaska, Dr. med.

Thomas Pulte, Dr. med.

Stefan Wolter, Dr. med.

Florian Seseke, Prof. Dr.

Juliane Künzel, Dr. med.

Marc-Oliver Grimm

Marc-Oliver Grimm, Prof. Dr.

Stefan Machtens, Dr.

Jonas Busch, Prof. Dr. med.

Ines Santiago, Dr. med.

Harald Junius, Dr.

Diana Standhaft,, Dr.

Günther Niegisch, PD Dr.

Thomas Steiner, Prof. Dr.

Peter J. Goebell,, PD Dr.

Susanne Krege, Prof. Dr.

Boris Hadaschik, Prof. Dr.

Severine Banek, Dr.

Florian Wagenlehner, Prof. Dr. med.

Adrian Pilatz, Prof. Dr.

Gunhild von Amsberg, Prof. Dr. med.

Florian Roghmann, PD Dr.

Martin Schostak,, Prof. Dr.

Frederik Wessels, PD Dr. med,

Hendrik Heers, Dr.

Jozefina Casuscelli, Dr.

Margitta Retz, Prof. Dr.

Martin Bögemann, PD Dr.

Marinela Augustin,, Dr.

Bernd Schmitz-Dräger, Prof. Dr.

Tilman Todenhöfer,, Prof. Dr.

Andreas Neisius,, PD Dr.

Steffen Rausch, Prof. Dr.

Friedemann Zengerling, Dr.

Stephan Degener, MD

Friedrich von Rundstedt, Prof. Dr.

Anna Katharina Seitz,, Dr.

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).

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).

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

A Randomised, Phase 3 Trial Comparing 3-weekly Docetaxel 75 mg/m2 (in a 3 Week Cycle) Versus 2-weekly Docetaxel 50 mg/m2 (in a 4 Week Cycle) in Combination With Darolutamide + ADT in Patients With mHSPC

Rate of grade 3-5 AEs, followed by rate of neutropenia grade 3/4 + grade 5 AEs t

PSA-response (PSA \<=0.2, \>0.2-4.0 und \>4.0 ng/ml) determined at week 28 after LPFD

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;

defined as the time (in days) from date of randomization until death from any cause

approx. every 90 days up to the date of first subsequent antineoplastic therapy for prostate cancer

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.

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.

approx. every 90 days up to the first date a subject experiences a pain progression. Pain to be assessed with a patient reported questionaire

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

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

Bayer

Jena University Hospital

Prof. Dr. Marc-Oliver Grimm

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Trial Comparing Docetaxel 75 mg/m2 (3w) Versus Docetaxel 50 mg/m2 (2w) in Combination With Darolutamide + ADT in mHSPC Patients	NCT05676203	Metastatic Horm...	Standard ADT (a... Standard Darolu... Docetaxel	18 Years -	Jena University Hospital
A Trial Comparing Docetaxel 75 mg/m2 (3w) Versus Docetaxel 50 mg/m2 (2w) in Combination With Darolutamide + ADT in mHSPC Patients	NCT05676203	Metastatic Horm...	Standard ADT (a... Standard Darolu... Docetaxel	18 Years -	Jena University Hospital

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