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Lutetium-177-PSMA-617 in Low Volume Metastatic Prostate Cancer

NCT03828838 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-11-14

No results posted yet for this study

Summary

Radioligand therapy (RLT) using Lu-177 labelled PSMA is a promising new therapeutic approach to treat metastatic prostate cancer. This tumor-specific treatment is directed against prostate-specific membrane antigen (PSMA), which is overexpressed in prostate cancer cells. In the last few years, several lutetium-177 (177Lu, β emitter) labeled PSMA ligands have been developed and are currently applied to treat metastatic castrate resistant prostate cancer (mCRPC) patients. However, there are no prospective studies published so far using this treatment approach in hormone sensitive setting. In this pilot study patients with hormone sensitive prostate cancer who did not undergo hormonal treatment will be treated with Lu-177 PSMA-617.

Conditions

  • Prostate Neoplasm

Interventions

DRUG

Lu-177 PSMA-617

Two cycles of Lu-177 PSMA (3GBq and 3-6 GBq)

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • James Nagarajah, Prof. · Radboudumc, Nijmegen, Nederland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2019-11-01
Completion
2019-11-01

Countries

  • Netherlands

Study Locations

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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 NCT03828838 on ClinicalTrials.gov