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View trial details
Overview
Official protocol title:
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF DAROLUTAMIDE PLUS ANDROGEN DEPRIVATION THERAPY (ADT) COMPARED WITH PLACEBO PLUS ADT IN PATIENTS WITH HIGH-RISK BIOCHEMICAL RECURRENCE (BCR) OF PROSTATE CANCER
Intervention/treatment:
Name given to the drug used in the clinical trial. This may be a code name, a chemical name of the active ingredient, a non-proprietary name or brand name.
DAROLUTAMIDE (BAY 1841788)
Medical condition:
The disease or condition that's being studied in the clinical trial.
Protocol code:
An alpha-numeric sequence generated by the sponsor that can vary in length. Used as a reference to help identify a specific clinical trial protocol. Formerly referred to as 'protocol number'.
21492
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
272759
Status:
The status for the clinical trial as a whole. Note that the status for each site may be different and should always be confirmed with the clinical trial sponsor. Health Canada uses information provided by the sponsor to an international clinical trial registry to determine status values for each clinical trial. Status values on the portal can include:
• Not yet recruiting - Participants are not yet being recruited or enrolled at any site.
• Recruiting - Participants are currently being recruited.
• Active, not recruiting - The clinical trial is ongoing but new participants are not currently being recruited or enrolled.
• On hold - The clinical trial has been temporarily stopped, but it may start again.
• Closed - The clinical trial has either ended normally and participants are no longer being examined or treated, or it has stopped early and will not start again.
• Unknown - The status of the clinical trial has not been verified in the registry in the last 2 years. Please contact the sponsor.
• No match, ongoing - Please contact sponsor for status information.
• Other - Please contact sponsor for status information.
Active, not recruiting
Approved:
The date that the clinical trial has been determined to meet Health Canada’s regulatory requirements. For drug clinical trials, this means that a no objection letter or an authorization was issued.
March 24, 2023
Trial phase:
The stage of a clinical trial, based on factors such as the objectives of the trial and number of participants. Phase data displayed in the portal is taken from international registry data.
For more information see "Phases of drug trials" on the Definitions webpage
Phase 3
For more information:
WHO ICTRP -
NCT05794906
This is an external link. The information is not authorized by the Government of Canada.
Eligibility
The characteristics people must have or the requirements they must meet to participate in the clinical trial. Eligibility criteria include both inclusion criteria (must have for a person to participate) and exclusion criteria (prevent a person from participating).
Review the exact criteria from the registry or the sponsor before making a decision to participate. The following values may be available on the portal:
Sex: an eligibility criteria based on biological characteristics. Information in the portal is based on available data and will default to 'all' when no other data is available.
Age: The age a person must be to participate in the clinical trial.
Accepts Healthy Volunteers: People who do not have the disease or condition can participate in the clinical trial.
Sex:
MALE
Accepts healthy volunteers:
No
Locations
Hôtel-Dieu de Lévis - Urology
Alberta
Kaye Edmonton Clinic - Dianne and Irving Kipnes Urology Centre
Edmonton, Alberta, T6G 1Z1
Prostate Cancer Centre
Calgary, Alberta, T2V 1P9
British Columbia
BC Cancer - Abbotsford
Abbotsford, British Columbia, V2S 0C2
BC Cancer - Victoria
Victoria, British Columbia, V8R 6V5
Vancouver Prostate Centre
Vancouver, British Columbia, V5Z 1M9
Nova Scotia
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9
Ontario
London Health Sciences Centre (LHSC) - London Regional Cancer Program (LRCP)
Princess Margaret Cancer Centre - Oncology Department
Toronto, Ontario, M5G 2M9
St. Joseph's Healthcare - Hamilton
Hamilton, Ontario, L8N 4A6
Quebec
Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec - Radio-oncologie
Trois-Rivières, Quebec, G8Z 3R9
CISSS de l'Outaouais - Hopital de Gatineau - Centre de cancerolgie
Gatineau, Quebec, J8P 7H2
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Sir Mortimer B. Davis Jewish General Hospital - Radiation Oncology
Montreal, Quebec, H3T 1E2
Urology South Shore Research - Research Department
Greenfield Park, Quebec, J4V 2H3
