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Castration-Resistant Prostate CarcinomaPhase 1NCT05037500

Decitabine/Cedazuridine and Enzalutamide for the Treatment of Metastatic Castrate Resistant Prostate Cancer

A Phase 1 study testing Decitabine and Cedazuridine and Enzalutamide in people with Castration-Resistant Prostate Carcinoma and Stage IV Prostate Cancer AJCC v8, run by Roswell Park Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase Ib trial is to find out the best dose decitabine/cedazuridine and possible benefits and/or side effects of decitabine/cedazuridine and enzalutamide in treating patients with castrate resistant prostate cancer that has spread to other places in the body (metastatic). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Decitabine and Cedazuridine and Enzalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
26 Jan 2022to 3 Jan 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male >= 18 years of age
  • Histological or cytological documentation of diagnosis of prostate cancer
  • Documented metastatic castrate resistant prostate cancer (mCRPC) patients currently on enzalutamide treatment
  • Tissue for correlative studies is needed; fresh biopsy is preferred where feasible (NOT mandatory) (nodal and visceral disease), particularly in patient at the recommended Phase 2 dose.
  • Initial dose escalation/de-escalation: Prior enzalutamide treatment and/or other approved treatments for CRPC for the dose finding phase (determination of MTD) of the study is allowed (Completed)
  • Expansion cohort: Once the MTD has been determined from the dose escalation/de-escalation portion of the study, patient eligibility for the expansion cohort will be genomically driven and will be restricted to metastatic CRPC patients with detectable genomic alterations in RB1 and/or TP53 obtained based on liquid/tissue biopsies. Enzalutamide naïve or patients currently on enzalutamide will be enrolled to the expansion cohort as long as they have detectable genomic alterations in RB1 and/or TP53
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  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Have testosterone < 50 ng/dL if not currently on primary androgen deprivation with an LHRH analogue (agonist or antagonist). Note: Patients who are currently on primary androgen deprivation with an LHRH analogue (agonist or antagonist) and have not undergone orchiectomy must continue with this regimen and for these patients, testosterone measurement is not required for eligibility.
  • Patient has adequate bone marrow and organ function as defined by the following laboratory values:
  • ANC>1000 (Obtained within 14 days prior to treatment start)
  • Platelets >= 100 x 10^9/L (obtained within 14 days prior to treatment start)
  • Hemoglobin (HGB) >= 9 g/dL (obtained within 14 days prior to treatment start)
  • Creatinine clearance > 50 mL/min (obtained within 14 days prior to treatment start)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN (obtained within 14 days prior to treatment start). If the patient has liver metastases, ALT and AST must still be =< 2.5 x ULN. Patients with liver metastases and AST/ALT above this limit will not be enrolled
  • Total bilirubin =< 1.5 x ULN; or total bilirubin (TBILI) =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's Syndrome (obtained within 14 days prior to treatment start)
  • Ability to swallow and retain oral medication (without crushing, dissolving, or chewing tablets)
  • Sexually active males must agree to use a condom during intercourse while taking the study drug and for at least 3 months after stopping study treatment. Sexually active males should not father a child during this period. A condom is required to be used by vasectomized men in order to prevent delivery of the drug via seminal fluid. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately
  • Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
  • NOTE: For blood chemistry labs, Roswell Park clinical blood chemistries are performed on plasma unless otherwise indicated

Who cannot join

  • Participant has a concurrent malignancy or malignancy within 3 years of treatment start, with the exception of adequately treated, basal or squamous cell carcinoma or non-melanomatous skin cancer
  • Participant has a known history of human immunodeficiency virus (HIV) infection (testing not mandatory)
  • Participant has clinically significant, uncontrolled heart disease and/or recent events including any of the following:
  • History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to treatment start
  • History of documented congestive heart failure (New York Heart Association functional classification III-IV)
  • Should not have active heart disease: uncompensated CHF; untreated arrhythmia, and no history of MI in the last 6 months
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  • Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to treatment start:
  • Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids and pummelos, star-fruit and Seville oranges
  • Patient who has received radiotherapy =< 4 weeks prior to start of treatment or limited field radiation for palliation =< 2 weeks prior to treatment start and, who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom >= 30% of the bone marrow was irradiated
  • Patients with central nervous system (CNS) involvement
  • Patients with seizure disorder
  • Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade <1 (Exception to this criterion: patients with any grade of alopecia are allowed to enter the study)
  • Unwilling or unable to follow protocol requirements
  • Participant has any other concurrent severe and/or uncontrolled medical condition that would cause, in the investigator's judgment, an unacceptable safety risk
  • Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: A Phase 1b Clinical Trial: Improving Outcomes With Androgen Pathway Inhibitors by Targeting DNA Methyltransferase Activity

This phase Ib trial is to find out the best dose decitabine/cedazuridine and possible benefits and/or side effects of decitabine/cedazuridine and enzalutamide in treating patients with castrate resistant prostate cancer that has spread to other places in the body (metastatic). Chemotherapy drugs, such as decitabine/cedazuridine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Enzalutamide blocks the use of androgen by the tumor cells. Giving decitabine/cedazuridine together with enzalutamide may reverse or help prevent the acquired therapeutic resistance that is observed when enzalutamide is used alone. Drug resistance occurs when cancer cells stop responding to a chemotherapy that had previously been effective.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the safety of oral decitabine and cedazuridine (decitabine/cedazuridine) in combination with enzalutamide in patients with metastatic castrate resistant prostate cancer (mCRPC).

SECONDARY OBJECTIVE:

  1. To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of oral decitabine/cedazuridine in combination with enzalutamide in patients with metastatic castrate resistant prostate cancer (mCRPC).

OUTLINE: This is a dose-escalation study of decitabine and cedazuridine.

Patients receive decitabine and cedazuridine orally (PO) once daily (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.

After completion of study treatment, patients are followed up at 30 days, then every 3 months for 24 months.

Being tested
Decitabine and Cedazuridine, Enzalutamide
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Decitabine and CedazuridineDrug

    Also called ASTX727, C-DEC, CDA Inhibitor E7727/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Combination Agent ASTX727

    Given PO

  • EnzalutamideDrug

    Also called ASP9785, MDV3100, Xtandi

    Given PO

Study groups in NCT05037500
Study groupRoleWhat they receive
Treatment (decitabine and cedazuridine, enzalutamide)ExperimentalPatients 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.
Receives: Drug: Decitabine and Cedazuridine; Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs)

    Assesses using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Up to 30 days post-treatment

Secondary outcomes (1)

  1. Maximum tolerated dose (MTD)

    The MTD will be defined as the dose level at which 0 out of 3 or < 2 out of 6 patients within the same cohort experience dose-limiting toxicity (DLT). DLTs will be defined as an AE or clinically significant abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with decitabine in cycle 1. These will be assessed using the NCI CTCAE version 5.0.

    Measured: Up to cycle 1 (1 cycle = 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2021
  2. Study start26 Jan 2022
  3. Primary completion17 Dec 2024
  4. Study completion3 Jan 2025

Why it stopped: PI closed study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05037500
Sponsor's protocol ID
I 1373721
Other IDs
NCI-2021-08860, I 1373721
Status last verified
Nov 2025
First submitted
26 Aug 2021
Last updated
12 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Decitabine and Cedazuridine and Enzalutamide in people with Castration-Resistant Prostate Carcinoma and Stage IV Prostate Cancer AJCC v8, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: PI closed study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) (time frame: Up to 30 days post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05037500.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.

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