What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including PARP inhibitors like Saruparib, enzalutamide, abiraterone, and docetaxel, have various side effects. PARP inhibitors often cause anemia, nausea, fatigue, and thrombocytopenia. Enzalutamide can lead to fatigue, seizures, and other central nervous system toxicities. Abiraterone is associated with fluid retention, hypokalemia, and hypertension. Docetaxel may cause febrile neutropenia and other chemotherapy-related toxicities. These side effects are generally manageable with supportive care and dose adjustments.

What prior FDA approvals exist?

Several PARP inhibitors have been approved by the FDA for the treatment of prostate cancer, particularly for those with specific genetic mutations. Rucaparib and olaparib are notable examples, approved for metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR) gene mutations, such as BRCA1/2. These approvals are based on their ability to target cancer cells with defective DNA repair mechanisms. Additionally, other systemic therapies like androgen receptor inhibitors (e.g., enzalutamide, apalutamide, and darolutamide) and chemotherapeutic agents (e.g., docetaxel, cabazitaxel) have been approved for various stages of advanced prostate cancer.

What other types of research exist?

Promising novel alternatives to Saruparib (AZD5305) for prostate cancer patients include: <ol> <li>Olaparib: A PARP inhibitor shown to improve radiographic progression-free survival in combination with abiraterone in the PROPEL trial.</li> <li></li> </ol> Niraparib: Another PARP inhibitor that demonstrated improved time to radiographic disease progression or death in the MAGNITUDE trial when combined with abiraterone in patients with HRR alterations. 3. Pembrolizumab: An immune checkpoint inhibitor for patients with metastatic CRPC with dMMR or high TMB, showing efficacy in selected subpopulations. 4. Lutetium-177-PSMA-617: A radiopharmaceutical targeting PSMA-positive metastatic CRPC, shown to improve overall survival in the VISION trial.

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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

Pivotal Trial

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 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

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 11Eligibility criteria met

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.