MR-Lymphography and Lymph Node Staging in Prostate Cancer - Full Text View

Sponsor:	Radboud University
Collaborator:	ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00185029

Purpose

This proposal is targeted at all patients with prostate cancer who are candidates for either curative surgery or curative radiotherapy in whom lymph node staging is indicated. Recently, it has been shown, that in patients with PSA <10 ng/ml and Gleason score < 7 the risk of lymph node metastases is low. Therefore, unnecessary PLND and non-invasive imaging can be avoided safely in this group. PLND is nowadays performed only in patients with intermediate or high risk for nodal metastases. Thus the subgroup of patients targeted in this study consists of patients with prostate cancer with a PSA >10 ng/ml and Gleason score > 6.

If the high sensitivity (90%) and negative predictive value (96%) of MRL can be validated in the 8 participating centres, in patients with a negative MRL invasive PLND may be avoided.
In patients with a positive MRL with enlarged nodes (larger than 8 mm) histological diagnosis may be obtained by imaged guided biopsy, and thus also in these patients avoid PLND. A limitation of image guide biopsy, however, is the 30% false negative rate. [Barentsz, Oyen, Wolf]
In patients with positive small nodes (smaller than 8 mm) the urologist may, focussed by the MRL findings of a positive node outside his “surgical field-of-view”, extend his dissection, and thus improve his accuracy.
Based on the expected higher sensitivity of MRL this technique will completely replace CT-scanning.

Condition	Intervention	Phase
Prostatic Neoplasms Lymphatic Metastasis	Procedure: Ferumoxtran-10 enhanced MRI (MRL)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	MRI With a Lymph Node Specific Contrast Agent: an Alternative for CT-Scanning and Lymph Node Dissection in Patients With Prostate Cancer?

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Nuclear Scans Prostate Cancer

Drug Information available for: Ferumoxtran-10

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:

Primary outcome parameters concern accuracy sensitivity, specificity, PPV and NPV of both MRL and CT

Secondary Outcome Measures:

Secondary outcome measures are costs per patient for each strategy. Besides this, quality of life after 6 months of follow up will be part of the analysis.

Estimated Enrollment:	396
Study Start Date:	April 2002
Estimated Study Completion Date:	August 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

prostate cancer
PSA > 10 or Gleason > 6 or T3 tumor
adult male
scheduled for lymphadenectomy
written informed consent

Exclusion Criteria:

Patient having undergone chemotherapy or radiotherapy of the pelvic area
patient having undergone resection of the pelvic tumor with lymphadenectomy
Patient included in another trial involving an investigational drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185029

Locations

Netherlands
NKI AVL
Amsterdam, Netherlands, 1066 CX
Catharina Hospital
Eindhoven, Netherlands, 5602 ZA
Ziekenhuis Zeeuws-Vlaanderen
Terneuzen, Netherlands, 4535 PA

Sponsors and Collaborators

Radboud University

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

Principal Investigator:

Jelle Barentsz, Phd MD

Radboud University Medical Centre

More Information

Publications:

Hovels AM, Heesakkers RA, Adang EM, Jager GJ, Barentsz JO. Cost-analysis of staging methods for lymph nodes in patients with prostate cancer: MRI with a lymph node-specific contrast agent compared to pelvic lymph node dissection or CT. Eur Radiol. 2004 Sep;14(9):1707-12. Epub 2004 Jul 13.

Harisinghani MG, Barentsz J, Hahn PF, Deserno WM, Tabatabaei S, van de Kaa CH, de la Rosette J, Weissleder R. Noninvasive detection of clinically occult lymph-node metastases in prostate cancer. N Engl J Med. 2003 Jun 19;348(25):2491-9. Erratum in: N Engl J Med. 2003 Sep 4;349(10):1010.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Heesakkers RA, Hövels AM, Jager GJ, van den Bosch HC, Witjes JA, Raat HP, Severens JL, Adang EM, van der Kaa CH, Fütterer JJ, Barentsz J. MRI with a lymph-node-specific contrast agent as an alternative to CT scan and lymph-node dissection in patients with prostate cancer: a prospective multicohort study. Lancet Oncol. 2008 Sep;9(9):850-6. Epub 2008 Aug 15.

ClinicalTrials.gov Identifier:	NCT00185029 History of Changes
Other Study ID Numbers:	sinerem1, 945-02-051
Study First Received:	September 13, 2005
Last Updated:	September 14, 2005
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:

prostate
ferumoxtran-10
lymph nodes
USPIO

Additional relevant MeSH terms:

Neoplasms
Lymphatic Metastasis
Neoplasm Metastasis
Prostatic Neoplasms
Neoplastic Processes
Pathologic Processes

Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012