The purpose of this research project is to test the safety and effectiveness of AZD5305 alone or darolutamide alone or AZD5305 and darolutamide in combination, when given as a treatment prior to radical prostatectomy. This research project will also find out what effects, good or bad, the study drugs have on you and your cancer.
- Category
-
Trial status
Not yet recruiting
-
Trial phase
Phase 1 Drug TrialEarly stage studies seeking initial evidence of safety, dosage and efficacy in small numbers of patients or healthy volunteers.
- Registry listing
-
ERM Project ID
99404
Trial contact details
-
Contact person
Niara Oliveira
-
Phone
+61 7 3163 6166
What you need to know
1. Male participants ≥ 18 years of age at the time of screening.
2. Participants deemed suitable for radical prostatectomy as judged by the Investigators based on the local practice.
3. Participants must have localised prostate cancer with unfavourable-intermediate risk/high risk/very high risk who are eligible for radical prostatectomy.
4. Adequate organ and marrow function (in the absence of transfusions or growth factor support within 14 days prior to enrolment).
What is involved for me?
This research project is broken down into 2 parts:
1. Treatment Part (participants will receive treatment with either AZD5305 alone, darolutamide alone or AZD5305 and darolutamide in combination prior to radical prostatectomy)
2. No Treatment Part (participants will not receive any treatment prior to radical prostatectomy).
The purpose of the No Treatment Part is to provide a comparison to see how well the study treatments work when given prior to radical prostatectomy compared to when the study treatments are not given prior.
The research project will have 3 periods:
1. Screening Period – To confirm if the research project is suitable for you and some tests will be required during this period. If you are on the No Treatment Part, you will still go through these tests.
2. Treatment Period – from the end of the Screening Period to when you have your surgery (Radical Prostatectomy Surgery)
The radical prostatectomy surgery is a surgery to remove the prostate and seminal vesicles. It can also involve removing some or most of the lymph nodes in your pelvic region, which can help with deciding further treatment decisions. Your study doctor will provide more information about this surgery and the associated risks.
3. Follow Up Period: You will have a Follow-Up visit 28 days after your surgery to check on your health and to conduct some tests and procedures
etc..As per the protocol