NCT04207944

The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial)

Active, enrolled Phase 2 Last updated 15 June 2025

What this trial tests

Phase 2 trial testing Sulindac 400 MG in IPMN in 100 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 July 2020

Primary endpoint
30 July 2026

31 October 2026

Quick facts

Lead sponsor	Duke University
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	100
Start date	10 July 2020
Primary completion	30 July 2026
Estimated completion	31 October 2026
Sites	4 locations across United States

Drugs / interventions tested

• Sulindac 400 MG — full drug profile →
• Placebo

Conditions studied

• IPMN — all drugs for IPMN →
• IPMN, Pancreatic — all drugs for IPMN, Pancreatic →

Sponsor

Duke University

Who can join

Adults 21 to 85, any sex, with IPMN or IPMN, Pancreatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multi-center randomized double-blind placebo controlled trial of patients with high-risk intraductal papillary mucinous neoplasms (IPMNs) of the pancreas. The primary objective is to evaluate the effect of sulindac on the presence or absence of progression of IPMN after up to 3 years of treatment.

Patients without contraindications will be considered to be eligible and will be required to have a cross-sectional imaging study of the pancreas by CT scan or MRI within 3 months of study entry to document residual IPMNs and to rule out any evidence of pancreatic cancer. Patients will be randomized to receive either sulindac (200 mg p.o. BID) plus standard radiographic and endoscopic surveillance or placebo plus standard radiographic and endoscopic surveillance. Randomization will be stratified by (1) whether the patient had high-grade dysplasia identified in the initial resection specimen (resected patients only) and (2) whether the patient is taking metformin at the time of randomization.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The tumour immune microenvironment and microbiome of pancreatic intraductal papillary mucinous neoplasms.
   Pollini T, Adsay V, Capurso G, Dal Molin M, et al · · 2022 · cited 31× · PMID 36057265 · DOI 10.1016/s2468-1253(22)00235-7
2. Absence of a pancreatic microbiome in intraductal papillary mucinous neoplasm.
   Pust MM, Rocha Castellanos DM, Rzasa K, Dame A, et al · · 2024 · cited 8× · PMID 38429112 · DOI 10.1136/gutjnl-2023-331012
3. Clinical and Molecular Attributes and Evaluation of Pancreatic Cystic Neoplasm.
   Raut P, Nimmakayala RK, Batra SK, Ponnusamy MP. · · 2023 · cited 4× · PMID 36535512 · DOI 10.1016/j.bbcan.2022.188851
4. Repurposing Drugs for Cancer Prevention: Targeting Mechanisms Common to Chronic Diseases.
   Choradia N, Szabo E. · · 2024 · cited 1× · PMID 39312454 · DOI 10.1097/ppo.0000000000000746