CLINICAL TRIAL

Decitabine and Cedazuridine for Prostate Cancer

Recruiting · 18+ · Male · Buffalo, NY

This study is evaluating whether a combination of drugs can improve the effectiveness of treatment for patients with castrate resistant prostate cancer.

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About the trial for Prostate Cancer

Eligible Conditions
Castration-Resistant Prostate Carcinoma · Stage IVB Prostate Cancer AJCC v8 · Stage IVA Prostate Cancer AJCC v8 · Prostatic Neoplasms · Stage IV Prostate Cancer AJCC v8

Treatment Groups

This trial involves 2 different treatments. Decitabine And Cedazuridine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Enzalutamide
DRUG
Decitabine and Cedazuridine
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
FDA approved

Eligibility

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Willing to undergo a biopsy, if readily available biopsy site present, i.e., nodal or visceral metastasis (if adequate formalin-fixed paraffin-embedded (FFPE) archival mCRPC samples are not available (or biopsy was taken longer than 6 months from start of study treatment), a fresh pre-treatment mCRPC biopsy needs to be obtained)
Male >= 18 years of age
Soft-tissue progression defined as an increase >= 20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions
Progression of bone disease (evaluable disease) or (new bone lesion[s]) by bone scan
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to cycle 1 (1 cycle = 28 days)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to cycle 1 (1 cycle = 28 days).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Decitabine and Cedazuridine will improve 1 primary outcome and 1 secondary outcome in patients with Prostate Cancer. Measurement will happen over the course of Up to 30 days post-treatment.

Incidence of adverse events (AEs)
UP TO 30 DAYS POST-TREATMENT
Assesses using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Maximum tolerated dose (MTD)
UP TO CYCLE 1 (1 CYCLE = 28 DAYS)
The MTD will be defined as the dose level at which at least 1 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.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the common side effects of decitabine and cedazuridine?

Results from a recent clinical trial showed that both agents can cause transient myelosuppression, but the incidence was not high enough to warrant dose modification. Myelosuppression appeared invariably reversible after discontinuation of treatment. Because severe neutropenia is associated with increased mortality, decitabine should be used carefully in elderly patients and cedazuridine must be used cautiously in women.

Anonymous Patient Answer

What causes prostate cancer?

Knowledge about the etiology of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is limited primarily because little research has been done. This lack of knowledge limits our ability to develop effective prevention strategies. Cancer Genetics Core investigators are combining their expertise in genetics, physiology and molecular biology to identify genetic predispositions and the best way to prevent prostate cancer.\nResearch in this area will lead to more effective treatment options and help reduce the number of unnecessary prostate biopsies and surgeries.

Anonymous Patient Answer

How serious can prostate cancer be?

Current guidelines recommend radical prostatectomy with intraoperative frozen section analysis for clinically organ confined localised prostate cancer. In accordance with these recommendations, low risk prostate cancers are treated surgically without the use of adjuvant therapy. However, it is clear that some prostate cancers do not fit into this category. They have either metastasized locally or systemically and therefore warrant more aggressive treatments.

Anonymous Patient Answer

What is the primary cause of prostate cancer?

Recent findings does not support an association between smoking and prostate cancer incidence. The higher prostate cancer incidence among the black cohort may be explained by earlier age at onset of smoking and longer duration of smoking. However, smoking was strongly associated with a lower age at first diagnosis of prostate cancer. Furthermore, our findings suggest that African Americans are more likely than whites to be diagnosed with prostate cancer late in life.

Anonymous Patient Answer

Have there been other clinical trials involving decitabine and cedazuridine?

Decitabine and cedazuridine are both active agents in determining prognosis in patients with advanced gastrointestinal stromal tumours. Data from a recent study suggests that further use of these agents in the treatment of GISTs should be explored in future trials.

Anonymous Patient Answer

What is prostate cancer?

An increasing proportion of men with PC are diagnosed at an earlier stage. This may reflect greater awareness of symptoms by clinicians. The exact cause remains unknown. Results from a recent clinical trial suggest that the increase in PC incidence can be attributed to changes in diagnostic practices rather than changes in exposure to carcinogens; however, further studies are needed to confirm our results and to identify other possible causes.

Anonymous Patient Answer

What are the signs of prostate cancer?

• The signs and symptoms of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) vary according to the stage and grade of cancer, but can be broadly categorized into four groups: • The early signs and symptoms include lower urinary tract symptoms such as frequency, urgency, and urge incontinence; the late signs and symptoms are skeletal metastases, which may occur within 12 months after the initial pathology report; • The biochemical features of prostate cancer are listed below; • • The pathologic features are listed below.

Anonymous Patient Answer

Is decitabine and cedazuridine safe for people?

Decitabine and cedazuridine are well tolerated at the doses studied. These agents have significant activity against pediatric leukemia. Decitabine was also found to be active In a recent study with only mild side effects. Cedazuridine did not show any active anti-leukemia effects but it produced severe myelosuppression in most patients.

Anonymous Patient Answer

How many people get prostate cancer a year in the United States?

Breast cancer affects about 1,200,000 women and colon cancer affects about 700,000 women each year in the United States; however, prostate cancer affects only about 100,000 men during their lifetime. This means that less than 10% of all cancers are related to sex. It also means that more than 20 million men over the age of 50 years will be affected by prostate cancer at some time in their lives.

Anonymous Patient Answer

What are common treatments for prostate cancer?

Although many treatment options are available for prostate cancer, some treatment options can cause serious side effects. Physicians need to be aware of common treatment options for prostate cancer when counseling patients.

Anonymous Patient Answer

What does decitabine and cedazuridine usually treat?

In spite of its effectiveness as an anti-cancer agent, decitabine behaved like conventional chemotherapy in terms of toxicity, side effects and response rate. Cedazuridine was better tolerated but still less effective than decitabine. Decitabine had better efficacy when compared with cedazuridine for patients who were previously treated with bortezomib. This suggests that these drugs could be combined in the treatment of relapsed patients.

Anonymous Patient Answer
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