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Anti-metabolites
Decitabine + Cedazuridine + Enzalutamide for Prostate Cancer
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to cycle 1 (1 cycle = 28 days)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs)
Secondary outcome measures
Maximum tolerated dose (MTD)
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
~2760
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,789 Total Patients Enrolled
20 Trials studying Prostate Cancer
636 Patients Enrolled for Prostate Cancer
National Comprehensive Cancer NetworkNETWORK
115 Previous Clinical Trials
7,617 Total Patients Enrolled
6 Trials studying Prostate Cancer
401 Patients Enrolled for Prostate Cancer
Gurkamal S ChattaPrincipal InvestigatorRoswell Park Cancer Institute
3 Previous Clinical Trials
74 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had another cancer within the last 3 years.I am taking certain medications that I cannot stop.My cancer has spread to my brain or spinal cord.I recently had radiation therapy on a small area.I can swallow and keep down pills.I have a serious health condition that is not under control.I do not have any major heart problems or recent heart events.I am fully active or can carry out light work.I have been diagnosed with HIV.My blood tests show my organs and bone marrow are working well.My testosterone level is below 50 ng/dL without hormone therapy.I have a seizure disorder.I am a man aged 18 or older.I agree to use a condom during sex while on the study drug and for 3 months after.My prostate cancer is spreading despite hormone therapy.My prostate cancer diagnosis was confirmed through lab tests.I still have side effects from previous cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (decitabine and cedazuridine, enzalutamide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What conditions are Decitabine and Cedazuridine typically prescribed to treat?
"Decitabine and Cedazuridine is frequently prescribed for patients who fall into the intermediate-2 category of IPSS risk, as well as to address other medical issues such as anemia, refractory anemias, or ipss high risk."
Answered by AI
Are Decitabine and Cedazuridine associated with any potential risks to individuals?
"Our team at Power thinks that Decitabine and Cedazuridine have a safety rating of one, due to minimal evidence backing up the efficacy or safety of these drugs."
Answered by AI
Have there been any other tests involving Decitabine and Cedazuridine that have yielded positive results?
"Presently, there is an abundance of clinical trials into Decitabine and Cedazuridine with 201 in total. Of those studies, 46 are currently in Phase 3 while the vast majority are based out of Germantown, Tennessee. Moreover, 7230 sites have been established to run these tests worldwide."
Answered by AI
Are there any slots available for enrolment in this research experiment?
"Affirmative. According to the data displayed on clinicaltrials.gov, this ongoing trial is still recruiting participants and has already admitted 18 patients from 1 site since its initial posting on January 26th 2022. The research was last updated on July 27th 2022."
Answered by AI
How many individuals are engaging in this experiment?
"Affirmative, per the information on clinicaltrials.gov this research project is accessible for participants. It was initially announced on January 26th 2022 and its details were most recently refreshed on July 27th 2022. This experiment requires 18 patients to be enrolled at one site."
Answered by AI
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