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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 90 months

Awards & highlights

EvoPAR-PR01 Trial Summary

This trial tests a new drug for advanced prostate cancer to see if it can slow down the spread of 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.Check my eligibility

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.See study design

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.

EvoPAR-PR01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer has spread, and I have at least one bone or soft tissue lesion that can be monitored with scans.

Select...

My cancer has a specific genetic change confirmed by tests.

Select...

I agree to use a condom during the study and for 6 months after.

Select...

I have prostate cancer that is sensitive to hormone therapy and not of a specific rare type.

Select...

I am a man aged 18 or older.

EvoPAR-PR01 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 90 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Radiographic Progression-Free Survival (rPFS)

Secondary outcome measures

BRCA and other HRR gene mutation status.

Health-related Quality of Life (HrQoL)

Overall Survival (OS)

+11 more

Other outcome measures

Number of TEAEs (treatment emergent adverse events), SAEs (serious adverse events), and AEs (adverse events) leading to dose modifications

EvoPAR-PR01 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

Abiraterone Acetate

2015

Completed Phase 4

~1880

Darolutamide

2018

Completed Phase 2

~100

Enzalutamide

2014

Completed Phase 4

~2760

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,610,903 Total Patients Enrolled

60 Trials studying Prostate Cancer

27,522 Patients Enrolled for Prostate Cancer

Arun Azad, MDPrincipal InvestigatorPeter MacCallum Cancer Centre, Australia

Kim Nguyen Chi, MDPrincipal InvestigatorBC Cancer, Canada

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What number of healthcare facilities are conducting this research?

"Currently, 174 clinical trial sites are recruiting patients for this medical study. Sites are located in Fayetteville, Los Angeles and San Diego - as well as many other locations throughout the USA. To minimize travel requirements, it is suggested to select a site close to your current residence if you choose to participate."

Answered by AI

Is this medical experiment accessible to those aged 55 and above?

"To be considered for this research, patients must fall within the age range between 18 to 130 years old. There are 150 studies available for minors and 1,398 trials open to seniors."

Answered by AI

Are there any positions open for participants in this research program?

"According to clinicaltrials.gov, this research is not currently recruiting volunteers as it was initially posted on November 24th 2023 and has not been updated since the 6th of same month. Nevertheless, there are still 1,504 different studies actively searching for potential participants at present."

Answered by AI

Is eligibility for this trial open to me?

"To meet the eligibilty criteria for this clinical trial, applicants must have prostate cancer and fall within a certain age range (18-130). Altogether, 1800 patients are sought after."

Answered by AI

How can potential adverse events be minimized when patients take Arm 1: AZD5305 + Physician's Choice NHA?

"The safety of Arm 1: AZD5305 + Physician's Choice NHA was rated a 3, as this is the final experimental stage and prior studies have indicated both efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

2023. "Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06120491.

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