NCT00185029

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
396

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2002

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

September 16, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 14, 2005

Conditions

Prostatic NeoplasmsLymphatic Metastasis

Keywords

prostateferumoxtran-10lymph nodesUSPIO

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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.

Interventions

Ferumoxtran-10 enhanced MRI (MRL)PROCEDURE

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

NKI AVL

Amsterdam, 1066 CX, Netherlands

Location

Catharina Hospital

Eindhoven, 5602 ZA, Netherlands

Location

Ziekenhuis Zeeuws-Vlaanderen

Terneuzen, 4535 PA, Netherlands

Location

Related Publications (3)

  • 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. doi: 10.1056/NEJMoa022749.

    PMID: 12815134BACKGROUND

  • 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. doi: 10.1007/s00330-004-2374-5. Epub 2004 Jul 13.

    PMID: 15249979RESULT

  • Heesakkers RA, Hovels AM, Jager GJ, van den Bosch HC, Witjes JA, Raat HP, Severens JL, Adang EM, van der Kaa CH, Futterer 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. doi: 10.1016/S1470-2045(08)70203-1. Epub 2008 Aug 15.

    PMID: 18708295DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsLymphatic Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jelle Barentsz, Phd MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

April 1, 2002

Study Completion

August 1, 2005

Last Updated

September 16, 2005

Record last verified: 2005-09

Locations

NL(3)