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NCT06888102
IIT2023-10-Posadas-PC-Net : A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer
EARLY_PHASE1 trial testing Neoadjuvant Epigenetic Therapy in High-risk Prostate Cancer in 20 participants. Currently enrolling.
1 October 2028
Quick facts
| Lead sponsor | Edwin Posadas, MD |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 April 2026 |
| Primary completion | 1 October 2028 |
| Estimated completion | 1 October 2029 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Neoadjuvant Epigenetic Therapy — full drug profile →
Conditions studied
- High-risk Prostate Cancer — all drugs for High-risk Prostate Cancer →
Sponsor
Edwin Posadas, MD — full company profile →
Who can join
18 and older, male only, with High-risk Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety of Using Epigentic Therapy
Time frame: 2 Years
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. -
Toxicity of Using Epigentic Therapy
Time frame: 2 Years
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. -
Feasibility - % of Patients Able to Undergo Surgery
Time frame: 2 Years
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 Stimula -
Feasibility - % of patients with grade 3/4 AEs related
Time frame: 2 Years
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 -
Feasibility - % of patients with evaluable tissue specimens
Time frame: 2 Years
Feasibility - Percentage of patients with evaluable tissue specimens following 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 define
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06888102
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for High-risk Prostate Cancer
Currently open trials in the same condition.
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- NCT07455097 — COMBINED PSMA-PET/CT AND MRI STAGING IN INTERMEDIATE AND HIGH-RISK PATIENTS PROSTATA-CANCER (COMBINE-P) · active not recruiting
- NCT07054346 — Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617 · Phase 1 · recruiting
- NCT07357259 — Delayed Pelvic Imaging With [68]Ga-PSMA PET/CT in a Patient With High-risk Prostate Cancer. · NA · recruiting
- NCT06636682 — FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer · Phase 2 · recruiting
Other Edwin Posadas, MD trials
Trials by the same sponsor.
- NCT01834651 — A Phase II Study of Cabozantinib (XL184) Therapy in Castrate Resistant Prostate Cancer (CRPC) With Visceral Metastases · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06888102 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Edwin Posadas, MD
- Last refreshed: 2 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06888102.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing