Decitabine + Cedazuridine + Enzalutamide for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of medications to determine the optimal dose and effects for treating prostate cancer that has spread and resists standard hormonal treatments. It examines the use of decitabine/cedazuridine (a combination drug) with enzalutamide (a hormonal therapy) to overcome the cancer's resistance to enzalutamide alone. Men with prostate cancer that no longer responds to usual treatments and is spreading might be suitable candidates, especially if they currently take enzalutamide. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new combination therapy.
Do I have to stop taking my current medications for the trial?
You may need to stop taking certain medications, especially if they are strong inducers or inhibitors of CYP3A4/5, at least 7 days before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining decitabine and cedazuridine is generally as safe as other similar treatments, meaning most people tolerate them well. Some side effects may occur, but they are typical for chemotherapy drugs. Studies indicate that enzalutamide can lower the risk of death in prostate cancer patients. It is usually safe, though it may cause some side effects, like most medications.
Overall, both treatments are considered manageable in terms of safety, with careful monitoring advised. Prospective trial participants should discuss these findings with their doctor to make an informed decision.12345Why are researchers excited about this study treatment for prostate cancer?
Researchers are excited about the combination of decitabine, cedazuridine, and enzalutamide for prostate cancer because it offers a novel approach by combining epigenetic modification with hormone therapy. Decitabine and cedazuridine work together to inhibit DNA methylation, potentially reactivating genes that suppress tumor growth, while enzalutamide targets androgen receptors to block the effects of male hormones that can fuel cancer. This dual-action strategy could enhance the effectiveness of prostate cancer treatment, offering hope for better outcomes compared to the current standard of care, which typically focuses on hormone therapy alone.
What evidence suggests that this trial's treatments could be effective for prostate cancer?
Studies have shown that enzalutamide can significantly improve survival for prostate cancer patients. Specifically, men taking enzalutamide had a 61% lower chance of their cancer worsening compared to those not taking it. Other research found that enzalutamide reduced the risk of death by 33% compared to a group not receiving the treatment. The combination of decitabine and cedazuridine has also shown promise, with patients having certain blood cancers living a median of 31.7 months. In this trial, participants will receive both enzalutamide and the combination of decitabine and cedazuridine. Together, these treatments might help overcome resistance to enzalutamide alone, potentially offering a new way to manage advanced prostate cancer.16789
Who Is on the Research Team?
Gurkamal Chatta, Dr.
Principal Investigator
Roswell Park Cancer Institute
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive decitabine and cedazuridine orally once daily on either days 1-3, 1-4, or 1-5 and enzalutamide orally once daily on days 1-28. Treatments repeat every 28 days for up to 6 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Decitabine and Cedazuridine
- Enzalutamide
Trial Overview
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Decitabine and Cedazuridine is already approved in European Union, United States for the following indications:
- Acute myeloid leukemia (AML) in adults who are ineligible for standard induction chemotherapy
- Adult patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older, or who have comorbidities precluding intensive induction chemotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Roswell Park Cancer Institute
Lead Sponsor
National Comprehensive Cancer Network
Collaborator
Citations
Correlative results from NCI CTEP/ETCTN 10330: A phase ...
Results: 19 pts were treated; all received paired biopsies. WES was adequate in 7/19 (37%) pts, with IDHm identified in 3/7 (43%) pts. All pts ...
Study Details | NCT05037500 | Decitabine/Cedazuridine ...
This phase Ib trial is to find out the best dose decitabine/cedazuridine and possible benefits and/or side effects of decitabine/cedazuridine and ...
Phase 2 Study of Oral Decitabine/Cedazuridine in ...
To evaluate preliminary safety and efficacy of oral decitabine/cedazuridine in combination with magrolimab. Primary Objective. •To evaluate the ...
4.
onclive.com
onclive.com/view/prolonged-overall-survival-observed-with-oral-decitabine-cedazuridine-in-mds-and-cmmlProlonged Overall Survival Observed With Oral Decitabine ...
The oral, fixed-duration combination of decitabine and cedazuridine induced a median overall survival of 31.7 months in patients with intermediate- and high- ...
5.
cancernetwork.com
cancernetwork.com/view/fda-accepts-snda-for-decitabine-cedazuridine-combo-in-newly-diagnosed-amlFDA Accepts sNDA for Decitabine/Cedazuridine Combo in ...
The CR rate was 46.5% (95% CI, 36.5%-56.7%), with a CRi rate of 16.8%, CRh rate of 5.0%, a CR plus CRi rate of 63.4% (95% CI, 53.2%-72.7%), a CR ...
Phase II trial of 10-day ASTX727 (decitabine/cedazuridine ...
Conclusions: The 10-day ASTX727-VEN combination showed safety profile comparable to other HMA-VEN regimens in salvage setting. ... Outcomes of 10- ...
Highlights of the NCCN Oncology Research Program in
Giving decitabine/cedazuridine together with enzalutamide may reverse or help prevent the acquired therapeutic resistance that is observed when ...
ASTX029 and Decitabine and Cedazuridine (ASTX727) for ...
Cedazuridine helps decitabine work better by helping to prevent its breakdown in the body. Giving ASTX029 and ASTX727 may be a safe and effective treatment ...
Astex Pharmaceuticals, Inc. ASTX727 Clinical Protocol
Based on this outcome, a dose combination of 100 mg cedazuridine with 35 mg decitabine (ie, intermediate dose between 30 mg and 40 mg) was selected for the ...
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