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Accuracy of Lymph Node Imaging in Prostate Cancer: PSMA PET-CT and Nano-MRI

NCT03223064 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-07-21

No results posted yet for this study

Summary

Following curative intended therapy in prostate cancer patients, a high proportion of patients (approx. 25%) relapse with local and/or distant recurrence. The metastasis of a lymph node (LN) in a patient with prostate cancer means that the disease has become systemic with the increased risk of disease progression. Therefore the ability to detect the presence of LN metastasis is important in terms of disease prognosis and treatment options. In the past, patients with LN metastasis have had poor prognoses due to the scarcity of accurate staging techniques and toxic treatment regimens such as radiotherapy. For those patients with a medium to high risk of having LN metastasis, the current procedure is a bilateral pelvic lymph node dissection (PLND). This is the standard procedure prior to curative treatment with either radical prostatectomy or radiation therapy. However, the procedure is not optimal due to the frequent inability to remove all positive lymph nodes within the dissection area. 41% of metastatic LN disease is not found, due to these LN being outside the routine surgery field. As a result, some urologists will perform an extended lymphadenectomy (e-PLND), which leads to extended operating times and the risk of complications. Also, therapy of LN metastases has limitations: more than 50% of metastatic LN are outside the routine (RTOG-CTV) radiation field. Thus the effect of standard LN radiotherapy is limited. Currently used imaging techniques such as CT and conventional MRI are also not sensitive enough to detect prostate cancer metastases due to the small size of the nodes (\< 8mm).

In this study, patients that undergo a pelvic lymph node dissection will be undergoing a 68Ga PSMA PET-CT and a nano-MRI prior to surgery. The results of the PSMA PET-CT and the nano-MRI will be validated using the pathology results of the (PLND).

Conditions

Interventions

DIAGNOSTIC_TEST

Ferumoxtran-10 enhanced MRI; MRI contrast agent

Patient undergo MRI with an USPIO contrast agent

DIAGNOSTIC_TEST

68Ga PSMA PET-CT

Patient undergo an 68Ga PSMA PET-CT scan

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Canisius-Wilhelmina Hospital

    collaborator OTHER

  • Catharina Ziekenhuis Eindhoven

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Fred Witjes, PhD · Radboud University Medical Centre Nijmegen

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

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 NCT03223064 on ClinicalTrials.gov