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EBRT + Lu-PSMA for N1M0 Prostate Cancer

NCT05162573 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-12-10

No results posted yet for this study

Summary

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.

Conditions

  • Prostatic Neoplasm

Interventions

DRUG

177Lu-PSMA-617

Dose-escalation of 177Lu-PSMA-617 (3, 6, 9 or 2x7.4 GBq) combined with external beam radiotherapy (EBRT)

RADIATION

EBRT

External Beam Radiotherapy

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER

  • Advanced Accelerator Applications

    collaborator INDUSTRY

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Wouter V Vogel, MD, PhD · The Netherlands Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2025-09-09
Completion
2025-09-09

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05162573 on ClinicalTrials.gov