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AZD5305 + Darolutamide for Prostate Cancer (ASCERTAIN Trial)
Phase 1
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tumour biopsy taken at diagnosis within approx 2 months of day 1 planned start of study treatment; post treatment tumour biopsy taken following 21 days (+ up to 7 days) of study treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial studies the effectiveness of two drugs alone or in combination to treat prostate cancer before surgery.
Who is the study for?
Men over 18 with newly diagnosed, localized prostate cancer suitable for surgery can join. They must have a biopsy sample available and be able to consent. Participants should not plan to father children and must use condoms during the study. Those with heart issues, severe diseases, or taking certain drugs affecting heart rhythm or immune system are excluded.
What is being tested?
The trial is testing AZD5305 alone, Darolutamide alone, and their combination in men before they undergo prostate removal surgery. The goal is to understand how these treatments affect prostate cancer at a biological level.
What are the potential side effects?
Potential side effects of AZD5305 and Darolutamide may include risks related to heart health such as changes in heartbeat rhythm, as well as possible interactions with other medications that could lead to serious conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ tumour biopsy taken at diagnosis within approx 2 months of day 1 planned start of study treatment; post treatment tumour biopsy taken following 21 days (+ up to 7 days) of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tumour biopsy taken at diagnosis within approx 2 months of day 1 planned start of study treatment; post treatment tumour biopsy taken following 21 days (+ up to 7 days) of study treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fold change in % γH2AX positive cells from baseline value in tumour samples
Secondary study objectives
Change from baseline in QTc value
Change from baseline in blood pressure reported as clinically significant
Change from baseline in heart rate reported as clinically significant
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Saruparib (AZD5305) onlyExperimental Treatment1 Intervention
Participant will receive Saruparib (AZD5305) once daily for 21 days (+ up to 7 days) unless unacceptable toxicity or withdrawal of consent. Following the 21 days of study treatment, participants should undergo radical prostatectomy on Day 22 (+ up to 7 days)
Group II: Saruparib (AZD5305) + DarolutamideExperimental Treatment2 Interventions
Participant will receive Saruparib (AZD5305) once daily + darolutamide twice daily for 21 days (+ up to 7 days) unless unacceptable toxicity or withdrawal of consent. Following the 21 days of study treatment, participants should undergo radical prostatectomy on Day 22 (+ up to 7 days).
Group III: No TreatmentExperimental Treatment1 Intervention
No study treatment is to be taken by the participants in this arm. Radical prostatectomy should be performed as per local practice
Group IV: Darolutamide OnlyExperimental Treatment1 Intervention
Participant will receive darolutamide twice daily for 21 days (+ up to 7 days) unless unacceptable toxicity or withdrawal of consent. Following the 21 days of study treatment, participants should undergo radical prostatectomy on Day 22 (+ up to 7 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Darolutamide
2018
Completed Phase 2
~100
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,121,567 Total Patients Enrolled
56 Trials studying Prostate Cancer
25,363 Patients Enrolled for Prostate Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart or blood vessel problems, including recent heart attacks or strokes.I do not have severe illnesses or infections like HepB, hepatitis C, or HIV.I have a bleeding disorder or a history of blood cancer.I haven't had any other cancer that could affect this study's safety or results in the last 3 years.I am not taking any medications that affect my heart's rhythm.I tested positive for HCV antibody but my PCR test for HCV RNA is negative.I am a man older than 18.My organs and bone marrow are working well.I have prostate cancer at a high risk level and am eligible for surgery.I can sign and understand the consent form.My heart's electrical activity is within normal limits.I am not taking any strong medication or supplements that affect liver enzymes, and I can follow the study schedule.I have signed and agreed to provide my genetic information for research.I am considered a good candidate for major prostate surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Saruparib (AZD5305) only
- Group 2: Saruparib (AZD5305) + Darolutamide
- Group 3: No Treatment
- Group 4: Darolutamide Only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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