Health TrialsbyHealthPanel

A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer

ConditionHigh-risk Prostate Cancer
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorEdwin Posadas, MD

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

AST and ALT < 2.5 x ULN

Disqualifiers

Active intercurrent illness or malignancy requiring therapy outside of prostate cancer.

Other anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization)

Currently participating in a study using an investigational, medicinal anti-cancer agent within 4 weeks prior to first dose of epigenetic therapy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Neoadjuvant Epigenetic Therapy

    Drug

    Participants will be assigned to receive one of the study interventions and will be monitored for safety and response. The duration of epigenetic therapy will be dependent on the treatment administered and will continue for the duration described in the cohort appendix for each respective combination, unless the participant: is no longer clinically benefiting (NLCB, as evidenced by symptomatic or radiographic disease progression and/or clinical deterioration); experiences any toxicity meeting specified discontinuation criteria (as described in the cohort appendix for each respective combination) or unacceptable toxicity in the best clinical discretion of the treating physician (i.e., Investigator discretion); reaches the maximum duration of study intervention; or withdraws consent.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Neoadjuvant Epigenetic TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety of Using Epigentic Therapy

Safety and tolerability using CTCAE version 5.0. To assess the safety, toxicity, and feasibility of using epigenetic therapy in the neoadjuvant setting for men undergoing radical prostatectomy (RP). Defined by the number of patients who demonstrate treatment related AEs, defined as grade 3 or 4, or grade 2 that causes a dose interruption.

Time frame
2 Years
2

Toxicity of Using Epigentic Therapy

Safety and tolerability using CTCAE version 5.0. To assess the safety, toxicity, and feasibility of using epigenetic therapy in the neoadjuvant setting for men undergoing radical prostatectomy (RP). Defined by the number of patients that undergo radical prostatectomy without delay due to epigenetic therapy.

Time frame
2 Years
3

Feasibility - % of Patients Able to Undergo Surgery

Feasibility - Percentage of patients able to undergo surgery. To assess the feasibility of measuring changes in gene expression (in radical prostatectomy \[RP\] tissue) induced by epigenetic therapy at conventional doses (defined by ongoing clinical work focusing on doses within the recommended dose and schedule per the manufacturer where safety has been defined) with a focus on Interferon Stimulated Genes

Time frame
2 Years
4

Feasibility - % of patients with grade 3/4 AEs related

Feasibility - Percentage of patients with grade 3/4 adverse events related to epigenetic therapy. To assess the feasibility of measuring changes in gene expression (in radical prostatectomy \[RP\] tissue) induced by epigenetic therapy at conventional doses (defined by ongoing clinical work focusing on doses within the recommended dose and schedule per the manufacturer where safety has been defined) with a focus on Interferon Stimulated Genes

Time frame
2 Years

Secondary outcomes

1

Progression Free Survival

To estimate the biochemical progression free survival in men treated with epigenetic therapy prior to prostatectomy.

Time frame
7 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Edwin Posadas, MD

Lead sponsor

Cedars-Sinai Medical Center

Sponsor institution

Source ClinicalTrials.gov
Apply now