MR-Lymphography and Lymph Node Staging in Prostate Cancer

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.

Sex

Male

Minimum age

18 Years

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

• BACKGROUNDHarisinghani 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 12815134
• RESULTHovels 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 15249979
• DERIVEDHeesakkers 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 18708295