Clinical trial • Phase III • Oncology

Enzalutamide for Prostate cancer | Hot flush

Phase III trial of Enzalutamide for Prostate cancer | Hot flush. 56 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Prostate cancer | Hot flush
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
24-11-2025
First CTIS Authorization Date
03-04-2026

Trial design

Phase III trial across 3 sites in Bulgaria.

Target Sample Size
56

Recruitment

Planned Sample Size
56
Recruitment Window Months
8

Geography

Total Number Of Sites
3
Total Number Of Participants
56

Bulgaria

Earliest CTIS Part Ii Submission Date
24-03-2026
Latest Decision Or Authorization Date
03-04-2026
Processing Time Days
10
Number Of Sites
3
Number Of Participants
56

Sites

Site Name
Complex Oncology Center Burgas EOOD
Department Name
First Department of Medical Oncology
Principal Investigator Name
Ivan Kazmukov
Principal Investigator Email
ikazmukov@gmail.com
Contact Person Name
Ivan Kazmukov
Contact Person Email
ikazmukov@gmail.com
Site Name
Medical Center Comac Medical Ltd.
Principal Investigator Name
Dobrin Svinarov
Principal Investigator Email
dobrin.svinarov@comac-medical.com
Contact Person Name
Dobrin Svinarov
Site Name
Medical Center Comac Medical Ltd.
Principal Investigator Name
Dobrin Svinarov
Principal Investigator Email
dobrin.svinarov@comac-medical.com
Contact Person Name
Dobrin Svinarov

Sponsor

Primary sponsor

Full Name
Astellas Pharma Global Development Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
Enzalutamide
Active Substance
Enzalutamide
Modality
Small molecule
Investigational Product Name
Apalutamide
Active Substance
Apalutamide
Modality
Small molecule
Investigational Product Name
Bicalutamide
Active Substance
Bicalutamide
Modality
Small molecule
Investigational Product Name
Fezolinetant
Active Substance
Fezolinetant
Modality
Small molecule

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