NCT07185672: PReCedeNT

PRRT Versus PRRT Plus Chemotherapy in GEP NET (PReCedeNT Trial)

Recruiting now Phase 3 Last updated 22 September 2025

What this trial tests

Phase 3 trial testing Peptide Receptor Radionuclide Therapy with Lu177 DOTATATE in Neuroendocrine Neoplasia's (NENs) in 162 participants. Currently enrolling.

Timeline

7 August 2019

Primary endpoint
7 August 2027

7 August 2027

Quick facts

Lead sponsor	Tata Memorial Hospital
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	162
Start date	7 August 2019
Primary completion	7 August 2027
Estimated completion	7 August 2027
Sites	2 locations across India

Drugs / interventions tested

• Peptide Receptor Radionuclide Therapy with Lu177 DOTATATE
• Capecitabine plus temozolamide — full drug profile →

Conditions studied

• Neuroendocrine Neoplasia's (NENs) — all drugs for Neuroendocrine Neoplasia's (NENs) →
• Neuroendocrine Tumor GEP Grade 1-3 — all drugs for Neuroendocrine Tumor GEP Grade 1-3 →
• Neuroendocrine Gastroenteropancreatic Tumour — all drugs for Neuroendocrine Gastroenteropancreatic Tumour →

Sponsor

Tata Memorial Hospital

Who can join

18 and older, any sex, with Neuroendocrine Neoplasia's (NENs) or Neuroendocrine Tumor GEP Grade 1-3. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Neuroendocrine tumours (NETs), better defined as neoplasms (NENs), are a heterogeneous group of neoplasms that range from well-differentiated tumours to more aggressive carcinomas. Peptide receptor radionuclide therapy (PRRT) with Lutetium-177 DOTATATE is the established standard of care for patients with well-differentiated metastatic or locally advanced GEP-NETs. It has demonstrated a significant improvement in outcomes compared to Octreotide LAR, both as a first-line and second-line treatment approach, following the results of NETTER-1 and NETTER-2 trials, respectively. ENETS guidelines recommend the use of Ga-68 labeled DOTANOC/TOC/TATAE imaging only for WHO Grade 1 NET whereas FDG PET is the preferred modality for WHO Grade 3 NEN and NEC. For Grade 2 tumors (Mib index ranging from 3-20%), there are no strong recommendations for the addition of FDG PETCT in existing diagnostic algorithm. FDG PET positivity has been shown to be an independent predictor of shorter progression-free and overall survival in NET patients undergoing peptide receptor radionuclide therapy (PRRT). (8) Consequently, it is imperative to address FDG-avid tumors by integrating PRRT and chemotherapy. There are no strong recommendations for the grade wise management of GEP-NETs particularly grade 2 \& 3. Although recently published NETTER 2 trial substantiated the role of PRRT as a first line treatment for advanced grade GEP-NETs, still there is lack of evidence supporting the addition of chemotherapy in management of GEP-NETs. Given the absence of a prospective study to establish this treatment regimen, we designed a Phase 3 Randomized Controlled Trial to evaluate the combination of PRRT and CAPE-TEM-based chemotherapy in patients with FDG-positive metastatic well-differentiated NETs.

Publications & conference data

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

1. Peptide receptor radionuclide therapy in neuroendocrine tumours: advances, combination strategies, and future directions.
   Virgolini IJ, Di Santo G, Santo G. · · 2026 · cited 2× · PMID 41689648 · DOI 10.1007/s00259-025-07750-w
2. PReCedeNT trial: Phase III randomized-controlled trial of Lutetium - 177 DOTATATE Peptide Receptor Radionuclide Therapy (PRRT) plus Chemotherapy versus PRRT alone in FDG-avid, Well-differentiated Gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
   Puranik AD, Dev ID, Yadav S, Rangarajan V, et al · · 2025 · PMID 41152774 · DOI 10.1186/s12885-025-15111-x