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Anti-metabolites

Decitabine + Cedazuridine + Enzalutamide for Prostate Cancer

Phase 1

Waitlist Available

Led By Gurkamal S Chatta

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

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

Must have

Ability to swallow and retain oral medication

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Must not have

Current use of specific medications that cannot be discontinued

Central nervous system (CNS) involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to cycle 1 (1 cycle = 28 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effect of decitabine/cedazuridine + enzalutamide in treating people with castrate resistant prostate cancer that has spread to other places in the body.

Who is the study for?

Men over 18 with metastatic castrate resistant prostate cancer, showing disease progression. They must have good performance status (able to carry out daily activities), low testosterone levels if not on androgen deprivation therapy, adequate organ function, and the ability to swallow pills. Prior treatments for prostate cancer are allowed in some phases of the trial. Participants must use contraception.

What is being tested?

The trial is testing the combination of decitabine/cedazuridine with enzalutamide to determine safe dosages and potential benefits or side effects in treating advanced prostate cancer that resists standard treatment. The goal is also to see if this combo can overcome resistance developed against enzalutamide alone.

What are the potential side effects?

Possible side effects include reactions related to chemotherapy such as nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, liver issues indicated by altered enzyme levels, and heart complications from pre-existing conditions.

Eligibility Criteria

Inclusion Criteria

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

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I can swallow and keep down pills.

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I am fully active or can carry out light work.

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My blood tests show my organs and bone marrow are working well.

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My testosterone level is below 50 ng/dL without hormone therapy.

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I am a man aged 18 or older.

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I agree to use a condom during sex while on the study drug and for 3 months after.

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My prostate cancer is spreading despite hormone therapy.

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My prostate cancer diagnosis was confirmed through lab tests.

Exclusion Criteria

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

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I am taking certain medications that I cannot stop.

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My cancer has spread to my brain or spinal cord.

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I recently had radiation therapy on a small area.

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I have a serious health condition that is not under control.

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I do not have any major heart problems or recent heart events.

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I have been diagnosed with HIV.

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I have a seizure disorder.

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I still have side effects from previous cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to cycle 1 (1 cycle = 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to cycle 1 (1 cycle = 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to cycle 1 (1 cycle = 28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (AEs)

Secondary study objectives

Maximum tolerated dose (MTD)

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: Treatment (decitabine and cedazuridine, enzalutamide)Experimental Treatment2 Interventions

Patients receive decitabine and cedazuridine PO QD on either days 1-3, 1-4, or 1-5 and enzalutamide PO QD on days 1-28. Treatments repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~3820

0 / 16Eligibility criteria met