Trials Sponsors Conditions Drugs Pricing

Conditions

metastatic castration-resistant prostate cancer

Outcome Measures

Primary Outcomes (2)

PFS defined as time from randomization to biochemical, clinical, or radiographic progression, or death from any cause, whichever occurs first.
QoL until progression measured using the German version of the FACIT-F scale

Secondary Outcomes (5)

50% PSA response (PSA50) defined as a PSA decrease of ≥ 50% at any time compared to baseline value
Percentage of change in PSA from baseline to 12 weeks
Maximum decline in PSA that occurs at any point after start of treatment
Symptomatic progression-free survival defined as time from randomization to clinical progression or death from any cause, whichever occurs first.
Overall Survival (OS) defined as time from randomization to death from any cause

Interventions

ABIRATERONE Type not reported

Testogel Dosiergel 16,2 mg/g GelType not reported

DOCETAXEL Type not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Testogel Dosiergel 16,2 mg/g Gel
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TRANSDERMAL GEL
View registry record
Formulated product
BAY 1841788
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Testogel Dosiergel 16,2 mg/g Gel
Named ingredient: Testosterone
View registry record
BAY 1841788
Named ingredient: darolutamide
View registry record

Eligibility Criteria

Sexmale

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ability to understand and willingness to sign a written informed consent form (ICF) document
Eastern Cooperative Oncology Group Performance status (ECOG PS) grade ≤2
Men ≥18 years

Sponsors & Collaborators

Universitaet Muenster
Otherlead

Study Sites (5)

Universitaetsklinikum Aachen AöR

Aachen, 52074, Germany

Matthias Saar+492418089374 msaar@ukaachen.de

Universitaetsklinikum Augsburg

Augsburg, 86156, Germany

Julie Steinestel+498214002348 Julie.Steinestel@uk-augsburg.de

Universitaet Muenster

Muenster, 48149, Germany

Katrin Schlack+492518344666

Central Study Contacts

Dr. Katrin Schlack

02518344666 katrin.schlack@ukmuenster.de

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

May 27, 2025

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2025-521051-23-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 06:14:15 UTC

Documents

D1_Protocol 2025-521051-23-00_redacted

You may not qualify if:

Pain due to metastatic prostate cancer > NRS 3 and/or requiring the onset or escalation of opioid treatment. Note: Patients should be on a stable dose for at least four weeks.
Prior systemic treatment for mCRPC
Hepatic metastases and/or evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g., femoral metastases with concern over fracture risk, severe and extensive spinal metastases with concern over spinal cord compression, progression on first line antihormonal therapy within 6 months)
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)
Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
Active uncontrolled infection, including known history of HIV/AIDS or hepatitis B or C
Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
Prior history of a thromboembolic event within the last 12 months that is not being treated with systemic anticoagulation
Uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite medical treatment
Major surgery (e.g., requiring general anesthesia) within 4 weeks before screening, or patients not fully recovered from prior surgery (i.e., unhealed wound). Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate
Known BRCA-mutations
Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
Long QT-syndrome
Thrombophilia
Migraine
+6 more criteria

Darolutamide and bipolar androgen therapy for mCRPC patients (DaroBAT)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations