Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer

What is the Purpose of this Study?

This study focuses on people who have prostate cancer and are planning to have a radical prostatectomy (removal of prostate and some surrounding tissue). The purpose of the study is to assess the safety, tolerability, and feasibility of using epigenetic therapy, azacitidine, before planned radical prostatectomy to determine whether it increases the sensitivity of the tumor to the patient’s immune system. Epigenetic therapy uses specially designed drugs (such as azacitidine) to reprogram cancer cells back to a normal, noncancerous state. Researchers also want to know whether the therapy will lower the chance that the cancer returns and how well the body responds to the treatment. The study will collect and analyze participants’ surgical tumor tissue after they receive epigenetic therapy to look for changes in immune system activity. The use of azacitidine in this study is considered experimental.


Eligibility

  • * Men electing to undergo radical prostatectomy with preoperative tissue available.
  • * Age ≥18 years
  • * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • * Adequate organ function defined by:
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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Maria Tarallo

More about this Clinical Trial

What is the full name of this clinical trial?

IIT2023-10-Posadas-PC-NET: A platform study of epigenetic therapy before prostatectomy in men with prostate cancer

Study Details
Disease Type/Condition

Prostate

Principal Investigator

Posadas, Edwin

Co-Investigators

Adam Weiner, Andrew Hung, Hyung Kim, Jun Gong, Michael Ahdoot, Robert Figlin, Stephen Freedland

Age Group

Adult

Phase

N/A

IRB Number

STUDY00003639

ClinicalTrials.gov ID

NCT06888102

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Maria Tarallo

Email
Maria.Tarallo@cshs.org
Study Detail
Disease Type/Condition

Prostate

Principal Investigator

Posadas, Edwin

Age Group

Adult

Phase

N/A

IRB Number

IIT2023-10-POSADAS-PC-NET

ClinicalTrials.gov ID

NCT06888102

Key Eligibility
ClinicalTrials.gov

Contact
Name

Maria Tarallo

Email
Maria.Tarallo@cshs.org