TheranosticTrials.org

Clinical Trial · NCT05162573

EBRT + Lu-PSMA for N1M0 Prostate Cancer

Overview

The PROQURE project aims to provide prostate cancer patients with more cure and better quality of life. The first part of this project (PROQURE-1) aims to explore an innovative combined modality treatment strategy for patients with node-positive prostate cancer (N1M0). The current standard of care for these patients, external beam radiotherapy (EBRT) of the prostate and regional pelvic nodes combined with 2-3 years androgen deprivation therapy (ADT), leads to suboptimal tumor control while inducing significant and potentially persistent toxicity. To overcome this, the current locoregional treatment is complemented with systemic Lutetium-177-PSMA radioligand therapy in a phase I study, with the aim to achieve better tumor control while potentially reducing or obviating ADT and its associated toxicity for future patients.

Sponsor

The Netherlands Cancer Institute

Phase

Phase 1

Contacts

Wouter V Vogel, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05162573

Drug / Compound

PSMA-617

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • cT2-4, partly determined by MRI;
  • Accepted for curative intent treatment with EBRT of the prostate and regional nodes + 3y ADT;
  • N1, determined by LND/SNP and/or PSMA PET/CT;
  • For patients who have partners of childbearing potential: Willingness to use a method of birth control with adequate barrier protection during the study and for 6 months after the study drug administration; and
  • WHO performance score 0-1;
  • iM0, determined by PSMA PET/CT;
  • Visually PSMA-positive primary tumor and nodes, largest lesion ≥ average liver uptake;
  • Signed written informed consen
  • Histologically proven prostate cancer;

Exclusion

  • Prior treatment with EBRT;
  • Reduced renal function (GFR \< 60 not older than 1 month before start of EBRT);
  • Prior or current malignant disease with potential impact on treatment outcome or survival;
  • Inability to adhere to radiation safety measures in hospital or at home;
  • Reduced salivary gland function (history of prior salivary gland disease); or
  • Prior treatment with radionuclide therapies, 177Lu-PSMA-617 or other;
  • Miction problems requiring pre-treatment with ADT.
  • Inability to comply to study procedures;
  • Inability to undergo the required biodistribution scans;
  • Prior treatment with ADT, already initiated \>1 month before the start of EBRT;
  • Reduced bone marrow reserve (Hb\<6 mmol/L, Leukocytes\<2.5 10E9/L, or Platelets\<100 10E9/L not older than 1 month before start of EBRT);