Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial

Last updated:
2026-08-15
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View trial details

Overview

Official protocol title:

PARALLEL PHASE III RANDOMIZED TRIALS OF GENOMIC-RISK STRATIFIED UNFAVORABLE INTERMEDIATE RISK PROSTATE CANCER: DE-INTENSIFICATION AND INTENSIFICATION CLINICAL TRIAL EVALUATION (GUIDANCE)

Intervention/treatment:
DAROLUTAMIDE (BAY 1841788, ODM-201)
Medical condition:
PROSTATE CANCER
Protocol code:
NRG-GU010
Control number:
260021
Status:
Active, not recruiting
Approved:
February 04, 2022
Trial phase:
Phase 3
For more information:
ClinicalTrials.gov - NCT05050084
This is an external link. The information is not authorized by the Government of Canada.

Eligibility

Sex: MALE
Age
18 Years and older
Accepts healthy volunteers: No

Contacts and locations

Contact
Sponsor
NRG ONCOLOGY

Locations

Alberta

Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
SUSPENDED

New Brunswick

Atlantic Health Sciences Corporation-Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
RECRUITING
Name
Site Public Contact
Role
CONTACT
Phone:
506-648-6890
Name
Robert D. Thompson
Role
PRINCIPAL_INVESTIGATOR

Ontario

Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
RECRUITING
Name
Site Public Contact
Role
CONTACT
Phone:
905-387-9495
Name
Theodoros Tsakiridis
Role
PRINCIPAL_INVESTIGATOR
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
RECRUITING
Name
Site Public Contact
Role
CONTACT
Phone:
416-946-4501
Name
Alejandro Berlin
Role
PRINCIPAL_INVESTIGATOR

Quebec

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, J1H 5N4
RECRUITING
Name
Site Public Contact
Role
CONTACT
Phone:
819-820-6480
Name
Annie Ebacher
Role
PRINCIPAL_INVESTIGATOR
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Québec, Quebec, G1R 2J6
RECRUITING
Name
Site Public Contact
Role
CONTACT
Name
Eric Vigneault
Role
PRINCIPAL_INVESTIGATOR
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, H3H 2R9
RECRUITING
Name
Site Public Contact
Role
CONTACT
Phone:
514-934-1934
Extension 48354
Name
Fabio L. Cury
Role
PRINCIPAL_INVESTIGATOR

Saskatchewan

Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
RECRUITING
Name
Site Public Contact
Role
CONTACT
Phone:
306-766-2213
Name
Asim Amjad
Role
PRINCIPAL_INVESTIGATOR
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
RECRUITING
Name
Site Public Contact
Role
CONTACT
Phone:
306-655-2914
Name
Ali A. El-Gayed
Role
PRINCIPAL_INVESTIGATOR
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