What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly those targeting androgen pathways, include androgen deprivation therapy (ADT), second-generation androgen receptor inhibitors (e.g., enzalutamide, abiraterone), and chemotherapy agents (e.g., docetaxel, cabazitaxel). Known side effects of ADT include hot flashes, decreased libido, fatigue, and osteoporosis. Enzalutamide and abiraterone can cause hypertension, fatigue, and increased risk of cardiovascular events. Chemotherapy agents like docetaxel and cabazitaxel are associated with neutropenia, neuropathy, and gastrointestinal symptoms. Investigational drugs like AC176 are being studied for their safety profiles, but common side effects may include those similar to existing therapies, such as fatigue, gastrointestinal disturbances, and hematologic abnormalities.

What prior FDA approvals exist?

Several FDA-approved treatments for prostate cancer target pathways involved in disease progression. Androgen receptor signaling inhibitors like enzalutamide and abiraterone are commonly used for metastatic castration-resistant prostate cancer (mCRPC). Radiopharmaceuticals such as radium-223 (Ra-223) target bone metastases, a common site of prostate cancer spread. Immunotherapies, including sipuleucel-T, have also been approved for mCRPC. These treatments aim to inhibit cancer growth and manage symptoms, similar to the investigational drug AC176 being studied for its safety, side effects, pharmacokinetics, and effectiveness in mCRPC patients.

What other types of research exist?

Promising novel alternatives to AC176 for prostate cancer treatment in 2024 include: 1) Bipolar Androgen Therapy (BAT), which involves cyclical high-dose testosterone therapy to resensitize CRPC to androgen-directed therapies. 2) P-PSMA-101 CAR-T cells, an immunotherapy targeting prostate-specific membrane antigen (PSMA) in metastatic CRPC. 3) Combination therapies such as ADT plus docetaxel and darolutamide, which have shown improved outcomes in high-risk/high-volume metastatic disease. 4) Ra-223 combined with abiraterone or enzalutamide, which has shown potential in improving survival and reducing fracture risk when used with osteoclast inhibitors.

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AC176 for Prostate Cancer

Phase 1

Waitlist Available

Research Sponsored by Accutar Biotechnology Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who have had surgical or medical castration

Patients must have progressed on at least 2 prior approved systemic therapies (in any setting), with at least 1 being abiraterone, or enzalutamide, or apalutamide or darolutamide

Must not have

Known symptomatic brain metastases requiring steroids (above physiologic replacement doses)

Congestive heart failure (New York Heart Association ≥ Grade 2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the study, approximately 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing AC176, a new drug, in patients with advanced prostate cancer that hasn't responded to other treatments. The drug works by breaking down a protein that helps the cancer grow.

Who is the study for?

This trial is for males over 18 with advanced prostate cancer that's resistant to castration and has worsened after at least two systemic therapies. Participants must have a life expectancy of more than three months, be able to swallow pills, and not plan on fathering children during the study.

What is being tested?

The drug AC176 is being tested in this trial. It aims to find a safe dose, understand side effects, how the body processes it (pharmacokinetics), and its effectiveness against metastatic castration-resistant prostate cancer.

What are the potential side effects?

While specific side effects of AC176 are not listed here, common ones in such trials include nausea, fatigue, allergic reactions, heart issues like QT prolongation (a type of irregular heartbeat), and potential risks related to liver or kidney function.

Eligibility Criteria

Inclusion Criteria

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

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I have undergone surgical or medical castration.

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My cancer has worsened after two treatments, including one like abiraterone.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need steroids for my brain metastases symptoms.

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I have been diagnosed with moderate to severe heart failure.

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My heart's pumping ability is below normal.

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I have conditions or take medications that could affect my heart's rhythm.

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I can swallow pills and don't have major stomach or bowel issues affecting medication absorption.

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I haven't had major surgery in the last 4 weeks.

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I have undergone more than 2 chemotherapy treatments.

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I plan to try for a child during or within 3 months after the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the study, approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the study, approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study, approximately 24 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

Adverse events (AEs)/Serious adverse events (SAEs)

Incidence of Electrocardiogram (ECG) abnormalities as a measure of safety and tolerability of AC176

Incidence of dose limiting toxicities (DLTs) from AC176 monotherapy

+2 more

Secondary study objectives

Prostate-Specific Antigen (PSA) response rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AC176 Dose Escalation as Single AgentExperimental Treatment1 Intervention

Single agent dose escalation of AC176. AC176 will be given orally (PO) on a 28-day cycle.

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

Prostate cancer treatments often target androgen signaling pathways, which are crucial for the growth and survival of prostate cancer cells. Androgen deprivation therapy (ADT) reduces androgen levels, slowing cancer progression. Second-generation androgen receptor inhibitors, such as enzalutamide and abiraterone, block androgen receptor signaling more effectively than first-generation agents. Novel treatments like AC176, currently under investigation, may offer additional mechanisms to inhibit cancer growth by targeting specific pathways involved in prostate cancer progression. Understanding these mechanisms helps patients and doctors choose the most effective treatment strategy, potentially improving outcomes and managing side effects.

Resistance to prostate cancer treatments.