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

NCT ID: NCT03223064

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-30
• Study Completion Date: 2017-12-31

Brief 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

Prostate Cancer; Lymph Node Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PSMA PET-CT and USPIO MRI

Group Type: EXPERIMENTAL

Ferumoxtran-10 enhanced MRI; MRI contrast agent

Intervention Type: DIAGNOSTIC_TEST

Patient undergo MRI with an USPIO contrast agent

68Ga PSMA PET-CT

Intervention Type: DIAGNOSTIC_TEST

Patient undergo an 68Ga PSMA PET-CT scan

Interventions

Ferumoxtran-10 enhanced MRI; MRI contrast agent

Patient undergo MRI with an USPIO contrast agent

Intervention Type: DIAGNOSTIC_TEST

68Ga PSMA PET-CT

Patient undergo an 68Ga PSMA PET-CT scan

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Male, aged 18 years Prostate cancer present (Gleason ≥ 7) and/or
• PSA ≥ 15 and/or
• Clinical or radiological Stage T3
• Subject will be undergoing a pelvic lymph node dissection as part of the prostate cancer treatment.
• Subject is willing to sign and date the study Informed Consent form
• Signed, written informed consent

Exclusion Criteria

• Patients who cannot lie still for at least 30 minutes or comply with imaging
• Subject has medical conditions that would limit study participation (per physician discretion)
• Subject has hemochromatosis and liver disease
• Subject has known allergy against Fe-products or dextranes
• Subject is enrolled in one or more concurrent studies that would confound the study results of this study as determined by the study investigators
• Previous treatment for prostate cancer (surgery, radiotherapy, chemotherapy, hormone androgen deprivation therapy)
• Proven bony metastatic disease, visceral metastases or lymph node metastases above the level of the aortic bifurcation
• Patients who will not get prostatectomy or pelvic lymph node dissection for any reason
• Patient has absolute contra-indications to undergoing MRI scanning

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: collaborator

Canisius-Wilhelmina Hospital

OTHER

Sponsor Role: collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fred Witjes, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Centre Nijmegen

Locations

Radboud University Medical Centre

Nijmegen, Gelderland, Netherlands

Site Status: RECRUITING

Catharina Ziekenhuis Eindhoven

Eindhoven, , Netherlands

Site Status: RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Bart Philips, MSc

Role: CONTACT

Bart.Philips@radboudumc.nl

Facility Contacts

Bart Philips

Role: primary

Bart.Philips@radboudumc.nl

Eric Vrijhof, PhD

Role: primary

Jean-Paul van Basten, PhD

Role: primary

Other Identifiers

ASTELLAS/MAGNIFY

Identifier Type: -

Identifier Source: org_study_id