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Hormone Therapy

AZD5305 for Prostate Cancer (EvoPAR-PR01 Trial)

Phase 3
Recruiting
Led By Arun Azad, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Metastatic disease as documented by the investigator prior to randomisation, with clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissue lesion that is suitable for repeated assessment with CT and/or MRI.
Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to determine cohort eligibility
Must not have
Prior treatment within 14 days with blood product support or growth factor support.
Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 90 months
Awards & highlights

Summary

This trial is testing a new drug called Saruparib combined with hormone treatment in adults with prostate cancer that has spread but still responds to hormones. The drug aims to stop cancer cells from repairing themselves, potentially slowing down the disease.

Who is the study for?
This trial is for men over 18 with metastatic castration-sensitive prostate cancer, showing at least one bone or soft tissue lesion. They must have started hormone therapy recently and be in good physical condition. Men with certain types of aggressive cancer cells, previous severe blood disorders, or prior treatment for metastatic cancer are excluded.
What is being tested?
The study aims to see if AZD5305 combined with a hormonal agent chosen by the physician works better than a placebo combined with the same hormonal agent. The main goal is to check if this combination can slow down the progression of prostate cancer as seen on imaging tests.
What are the potential side effects?
Potential side effects may include issues related to organ function and bone marrow suppression due to AZD5305 or other hormonal agents used. There might also be risks associated with gastrointestinal problems that could affect how well patients absorb the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread, and I have at least one bone or soft tissue lesion that can be monitored with scans.
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My cancer has a specific genetic change confirmed by tests.
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I agree to use a condom during the study and for 6 months after.
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I have prostate cancer that is sensitive to hormone therapy and not of a specific rare type.
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I am a man aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received blood products or growth factors in the last 14 days.
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I have lasting side effects from cancer treatment that are moderate or worse.
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I have or might have a history of myelodysplastic syndromes or acute myeloid leukemia.
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I have had severe low blood cell counts for more than 2 weeks.
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I have a condition that makes me bleed easily.
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I have a history of heart rhythm problems or heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 90 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 90 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Radiographic Progression-Free Survival (rPFS)
Secondary study objectives
Assessment of PSA (prostate-specific antigen) in participants in mCSPC
Health-related Quality of Life (HrQoL)
Overall Survival (OS)
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1: Saruparib (AZD5305) + Physician's Choice NHAExperimental Treatment4 Interventions
Saruparib (AZD5305) + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)
Group II: Arm 2: Placebo + Physician's Choice NHAPlacebo Group4 Interventions
Placebo + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Darolutamide
2018
Completed Phase 2
~100
Abiraterone Acetate
2015
Completed Phase 4
~1880
Enzalutamide
2014
Completed Phase 4
~3820

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for prostate cancer include androgen deprivation therapy (ADT), androgen receptor inhibitors, and PARP inhibitors. ADT works by reducing the levels of androgens (male hormones) that can stimulate the growth of prostate cancer cells. Androgen receptor inhibitors, such as enzalutamide and apalutamide, block the action of androgens on the prostate cancer cells, preventing them from growing and spreading. PARP inhibitors, like the investigational drug Saruparib (AZD5305), target cancer cells with specific genetic mutations by blocking the PARP enzyme, which is involved in DNA repair. This leads to the accumulation of DNA damage and ultimately the death of cancer cells. Understanding these mechanisms is crucial for prostate cancer patients as it helps in selecting the most effective treatment based on the cancer's characteristics and the patient's overall health.
New therapies for castration-resistant prostate cancer: efficacy and safety.

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Who is running the clinical trial?

AstraZenecaLead Sponsor
4,370 Previous Clinical Trials
288,735,895 Total Patients Enrolled
60 Trials studying Prostate Cancer
27,732 Patients Enrolled for Prostate Cancer
Arun Azad, MDPrincipal InvestigatorPeter MacCallum Cancer Centre, Australia
Kim Nguyen Chi, MDPrincipal InvestigatorBC Cancer, Canada
~1200 spots leftby Jan 2028