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

NCT03223064 | Unknown

• 1 other identifier: ASTELLAS/MAGNIFY
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Concordance between and sensitivity and specificity of PSMA PET-CT and USPIO enhanced MRI

  The sensitivity and specificity of the PSMA PET-CT and nano-MRI will be determined based upon pathological validation

  Within 8 weeks before pelvic lymph node dissection

Study Arms (1)

PSMA PET-CT and USPIO MRI

EXPERIMENTAL

Diagnostic Test: Ferumoxtran-10 enhanced MRI; MRI contrast agent; Diagnostic Test: 68Ga PSMA PET-CT

Interventions

Ferumoxtran-10 enhanced MRI; MRI contrast agent DIAGNOSTIC_TEST

Patient undergo MRI with an USPIO contrast agent

PSMA PET-CT and USPIO MRI

68Ga PSMA PET-CT DIAGNOSTIC_TEST

Patient undergo an 68Ga PSMA PET-CT scan

PSMA PET-CT and USPIO MRI

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Astellas Pharma Inc: collaborator
• Canisius-Wilhelmina Hospital: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator

Study Sites (3)

Radboud University Medical Centre

Nijmegen, Gelderland, 6500HB, Netherlands

RECRUITING

Catharina Ziekenhuis Eindhoven

Eindhoven, Netherlands

RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, 6532 SZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fred Witjes, PhD

  Radboud University Medical Centre Nijmegen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bart Philips, MSc

CONTACT

Bart.Philips@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 19, 2017
• Study Start: December 30, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)