20 Participants Needed

Epigenetic Therapy for Prostate Cancer

CT
Overseen ByClinical Trial Navigator
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for prostate cancer that aims to boost the body's immune response to the tumor. The focus is on neoadjuvant epigenetic therapy, which changes how certain genes are expressed without altering the DNA sequence, to determine if it can make the cancer more sensitive to the immune system. Men scheduled for prostate surgery with pre-surgery tissue samples available might be suitable for this study. The main goal is to assess the treatment's safety and effectiveness against the tumor. As an Early Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on other anti-cancer therapies, you may need to stop those before participating.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that epigenetic therapy, tested before prostate surgery, aims to enhance the body's immune response against cancer. Although specific safety data from past studies on this therapy is lacking, early trials like this one often focus on safety assessment. In this trial phase, researchers primarily evaluate how well participants tolerate the treatment.

For similar treatments given before surgery, known as neoadjuvant therapies, studies have shown they can be safe. This therapy aims to make the cancer more manageable during surgery. Since this is an early trial phase, the main focus is on understanding how the treatment affects the body and identifying any potential side effects early on.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for prostate cancer, which often include surgery, radiation, or hormone therapy, Neoadjuvant Epigenetic Therapy acts on the very blueprint of cancer cells—their DNA. This therapy targets epigenetic changes, which are like switches that turn genes on or off without altering the DNA sequence itself. Researchers are excited because this approach has the potential to reverse the cancer cells' growth patterns by reprogramming them back to a normal state. This could lead to more effective treatments with fewer side effects, offering new hope for patients with prostate cancer.

What evidence suggests that this treatment might be an effective treatment for prostate cancer?

Research has shown that altering certain biological pathways can affect prostate cancer growth. For example, one study found that reducing levels of a specific gene called ARNTL led to a noticeable slowdown in the growth of prostate cancer cells. The Neoadjuvant Epigenetic Therapy under study in this trial aims to help the immune system recognize and attack cancer cells more effectively. Although detailed information on its effects in humans with prostate cancer remains limited, similar treatments for other cancer types have shown promising results. This suggests that epigenetic therapy might also be effective for treating prostate cancer.14678

Who Is on the Research Team?

EP

Edwin Posadas, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for men with localized prostate cancer who are scheduled for radical prostatectomy. Participants should be interested in trying a treatment that may make their immune system better at attacking the tumor.

Inclusion Criteria

I am a man choosing to have surgery to remove my prostate and have tissue samples available from before the surgery.
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
My liver, kidney, and blood tests are within safe ranges.
See 2 more

Exclusion Criteria

I have another illness or cancer that needs treatment besides prostate cancer.
I have not had recent cancer treatments like chemotherapy or surgery.
Currently participating in a study using an investigational, medicinal anti-cancer agent within 4 weeks prior to the first dose of epigenetic therapy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Epigenetic Therapy

Participants receive epigenetic therapy to increase tumor sensitivity to the immune system before prostatectomy

Up to 4 weeks

Prostatectomy

Participants undergo radical prostatectomy after receiving epigenetic therapy

Follow-up

Participants are monitored for safety, toxicity, and progression-free survival after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Neoadjuvant Epigenetic Therapy
Trial Overview The study is testing epigenetic therapy given before surgery to see if it's safe and can help the body fight prostate cancer more effectively. It's an open-label, non-randomized trial focusing on how well this therapy works and its effects on certain biomarkers.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant Epigenetic TherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Edwin Posadas, MD

Lead Sponsor

Trials
4
Recruited
140+

Published Research Related to This Trial

Exercise is strongly supported as an effective strategy to manage several adverse effects of androgen deprivation therapy (ADT) in prostate cancer patients, including loss of muscle mass, fatigue, and declining physical function.
In addition to physical benefits, exercise may also improve mental health outcomes such as depression and anxiety, suggesting it plays a crucial role in enhancing overall quality of life and survivorship for men undergoing ADT.
The role of exercise in the management of adverse effects of androgen deprivation therapy for prostate cancer: a rapid review.Edmunds, K., Tuffaha, H., Scuffham, P., et al.[2021]

Citations

NCT06888102 | A Platform Study of Epigenetic Therapy ...This is an open-label, non-randomized, exploratory platform protocol designed to assess the safety and antitumor activity of epigenetic therapies in ...
ESMO 2024: Targeting Epigenetic PathwaysPosttreatment ARNTL levels were associated with patients' clinical outcomes and ARNTL knockout strongly decreased prostate cancer cell growth.
Epigenetic Therapy for Prostate CancerTrial Overview The study is testing epigenetic therapy given before surgery to see if it's safe and can help the body fight prostate cancer more effectively.
Precision epigenetic therapies in oncology - PMCMore promising results were seen in neoadjuvant chemotherapy of HER2+ locally advanced BC. In this context, vorinostat significantly increased the efficacy of ...
Epigenetic regulation of TP53 is involved in prostate ...It is commonly prescribed with neoadjuvant hormone therapy for intermediate/high-risk PCa patients as a tumor downstaging strategy. The ...
Current Status of Neoadjuvant Treatment Before Surgery in ...Results and Discussion: Neoadjuvant therapy is not recommended in daily practice by any international guideline. The National Comprehensive ...
A New Chapter in Neoadjuvant Therapy for High-risk ...Up to two cycles of neoadjuvant LuPSMA (5 GBq) alone before surgery were safe and delivered relevant doses of radiation to tumor-bearing tissues ...
Safety and efficacy of genomic biomarker-guided neoadjuvant ...This study aims to verify whether genomic biomarker-guided neoadjuvant therapy for locally advanced PCa and OMPCa can result in an improvement in the ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security