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20 Participants Needed

Epigenetic Therapy for Prostate Cancer

Overseen ByClinical Trial Navigator

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: Edwin Posadas, MD

Must not be taking: Chemotherapy, Hormonal therapy

Disqualifiers: Active illness, Other malignancy, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This is an open-label, non-randomized, exploratory platform protocol designed to assess the safety and antitumor activity of epigenetic therapies in participants with localized prostate cancer who are undergoing radical prostatectomy. The epigenetic therapy is intended to increase the sensitivity of the underlying tumor to the patient's immune system. The platform study will evaluate safety, biomarkers, and clinical activity of an epigenetic therapy. The particular details relevant to each module within this platform study will be provided as appendices to the core protocol.

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.

What data supports the effectiveness of the treatment Neoadjuvant Epigenetic Therapy for prostate cancer?

Research indicates that targeting epigenetic changes, like DNA methylation and histone modifications, can potentially reverse abnormal gene expression in prostate cancer, making it a promising treatment approach. Although success in solid tumors like prostate cancer has been limited compared to blood cancers, new, less toxic drugs are being developed, and combining these with other treatments shows promise.¹ ² ³ ⁴ ⁵

Is epigenetic therapy for prostate cancer safe for humans?

Epigenetic therapies, which target changes in gene expression without altering DNA, are being developed for prostate cancer and other solid tumors. These treatments are generally considered less toxic and more specific, but their safety in humans is still being evaluated, especially in comparison to their success in blood cancers.¹ ⁵ ⁶ ⁷ ⁸

How is Neoadjuvant Epigenetic Therapy different from other prostate cancer treatments?

Neoadjuvant Epigenetic Therapy is unique because it targets reversible changes in gene expression, such as DNA methylation and histone modifications, which are key drivers of prostate cancer. Unlike traditional treatments, this therapy aims to restore normal gene function by using compounds that specifically target the enzymes responsible for these epigenetic changes, potentially offering a new approach to managing prostate cancer.³ ⁴ ⁵ ⁹ ¹⁰

Research Team

Edwin Posadas, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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.

I am 18 years old or older.

Written informed consent obtained from subject and ability for subject to comply with the requirements of the study

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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

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

Treatment Details

Interventions

Neoadjuvant Epigenetic Therapy

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Neoadjuvant Epigenetic TherapyExperimental Treatment1 Intervention

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Who Is Running the Clinical Trial?

Edwin Posadas, MD

Lead Sponsor

Trials

Recruited

140+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]