SPECT-CT Guided Lymphatic Mapping and Sentinel Lymphadenectomy (LM/SL) in Prostate Cancer

NCT00773318 | Terminated

• 2 other identifiers: R-06-43312638
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Nodal staging is a key-step in pre-treatment assessment of prostate cancer. In patients with a low probability of nodal metastasis, bilateral pelvic lymphadenectomy is controversial. The large majority of them (\> 80%) are free of nodal disease in obturator and external iliac stations. On the other hand, skip metastases located outside the standard lymphadenectomy may be missed, particularly in more proximal nodal stations (i.e. common iliac nodes and pre-sacral nodes). In prostate cancer, growing data indicate the potential utility of LM/SL, particularly in patients with a low pre-test probability of nodal disease. However, very few data have been reported on the feasibility and the utility of SPECT/CT following LM/SL. In a pilot study including 11 patients with prostate cancer, Kizu and colleagues used a software image fusion from separate SPECT and CT studies. These authors concluded to the utility of image fusion to localize anatomically the SLNs. They also suggested the use of hardware fusion from a single gantry SPECT/CT device for accurate detection of SLNs. Accordingly, Corvin and colleagues recently reported the suitability of sentinel node detection in a series of 28 patients with prostate cancer; in this study, an integrated single slice SPECT/CT device was used to localize the SLNs. In the light of the encouraging data from literature and our own preliminary clinical experience, we hypothesized that the use of integrated SPECT/low-dose multislice CT guided LM/SL may be of clinical interest in patients with prostate cancer.

Conditions

Prostate Cancer

Keywords

LM/SL; SPECT/low-dose multislice CT

Outcome Measures

Primary Outcomes (1)

• Technical feasibility and clinical utility of LM/SL with SPECT/CT in patients with early stage prostate cancer versus CLND.

  1 year - 2 years

Secondary Outcomes (1)

• Tolerability, operating time, and complications rate of SPECT/CT guided LM/SL

  1 year - 2 years

Study Arms (1)

A

EXPERIMENTAL

Patients with histologically proven AJCC stages I - II - III prostate cancer including men with clinical T3N0M0 disease, men with PSA \> 10 mg/ml, and men with Gleason score of 8-10. Prostate cancer patients scheduled for prostatectomy and pelvic lymph node dissection (CLND). Arm A = SPECT/CT guided LM/SL versus CLND

Procedure: SPECT/CT guided LM/SL

Interventions

SPECT/CT guided LM/SL PROCEDURE

Detection, localization, and removal of sentinel lymph node (s) from prostate cancer guided by an integrated SPECT/low-dose multislice CT

Also known as: Sentinel lymph node detection

A

Eligibility Criteria

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

You may qualify if:

• Patients with histologically proven prostate cancer
• Initial staging (Bone scan, CT, or MRI) according to the NCCN guidelines
• Patients with AJCC stages I - II - III prostate cancer including men with clinical T3N0M0 disease, men with PSA \> 10 mg/ml, and men with Gleason score of 8-10 (high grade disease)
• Prostate cancer patients will be scheduled for prostatectomy and pelvic lymph node dissection
• Informed consent signed by the patient

You may not qualify if:

• Patients with no histological evidence of prostate cancer
• Patient with regionally advanced disease or metastatic disease (T4, and/or N1, and/or M1)
• Patients with clinically and/or radiologically evident regional lymph node metastases
• Patients who are not scheduled for radical prostatectomy and pelvic lymph node dissection
• Patients with physical and/or psychological contraindications
• Recent studies in Nuclear Medicine with long half-time isotopes (i.e. T ½ \> 48h; 111In, 67Ga, 201Tl, 131I) performed within 1 week preceding the LM/SL

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• London Regional Cancer Program, Canada: collaborator
• University of Western Ontario, Canada: collaborator

Study Sites (1)

University Hospital - Dpt. of Nuclear Medicine

London, Ontario, Canada

Location

Related Publications (10)

• Weckermann D, Dorn R, Trefz M, Wagner T, Wawroschek F, Harzmann R. Sentinel lymph node dissection for prostate cancer: experience with more than 1,000 patients. J Urol. 2007 Mar;177(3):916-20. doi: 10.1016/j.juro.2006.10.074.

  PMID: 17296375 BACKGROUND

• Corvin S, Schilling D, Eichhorn K, Hundt I, Hennenlotter J, Anastasiadis AG, Kuczyk M, Bares R, Stenzl A. Laparoscopic sentinel lymph node dissection--a novel technique for the staging of prostate cancer. Eur Urol. 2006 Feb;49(2):280-5. doi: 10.1016/j.eururo.2005.08.021. Epub 2005 Dec 9.

  PMID: 16364536 BACKGROUND

• Kizu H, Takayama T, Fukuda M, Egawa M, Tsushima H, Yamada M, Ichiyanagi K, Yokoyama K, Onoguchi M, Tonami N. Fusion of SPECT and multidetector CT images for accurate localization of pelvic sentinel lymph nodes in prostate cancer patients. J Nucl Med Technol. 2005 Jun;33(2):78-82.

  PMID: 15930020 BACKGROUND

• Schumacher MC, Burkhard FC, Thalmann GN, Fleischmann A, Studer UE. Is pelvic lymph node dissection necessary in patients with a serum PSA<10ng/ml undergoing radical prostatectomy for prostate cancer? Eur Urol. 2006 Aug;50(2):272-9. doi: 10.1016/j.eururo.2006.01.061. Epub 2006 Feb 28.

  PMID: 16632187 BACKGROUND

• Weckermann D, Goppelt M, Dorn R, Wawroschek F, Harzmann R. Incidence of positive pelvic lymph nodes in patients with prostate cancer, a prostate-specific antigen (PSA) level of < or =10 ng/mL and biopsy Gleason score of < or =6, and their influence on PSA progression-free survival after radical prostatectomy. BJU Int. 2006 Jun;97(6):1173-8. doi: 10.1111/j.1464-410X.2006.06166.x.

  PMID: 16686707 BACKGROUND

• Scardino P. Update: NCCN prostate cancer Clinical Practice Guidelines. J Natl Compr Canc Netw. 2005 Nov;3 Suppl 1:S29-33. No abstract available.

  PMID: 16280109 BACKGROUND

• de Bonilla-Damia A, Roberto Brouwer O, Meinhardt W, Valdes-Olmos RA. Lymphatic drainage in prostate carcinoma assessed by lymphoscintigraphy and SPECT/CT: its importance for the sentinel node procedure. Rev Esp Med Nucl Imagen Mol. 2012 Mar-Apr;31(2):66-70. doi: 10.1016/j.remn.2011.09.003. Epub 2011 Nov 3.

  PMID: 22055110 BACKGROUND

• Vermeeren L, Valdes Olmos RA, Meinhardt W, Bex A, van der Poel HG, Vogel WV, Sivro F, Hoefnagel CA, Horenblas S. Value of SPECT/CT for detection and anatomic localization of sentinel lymph nodes before laparoscopic sentinel node lymphadenectomy in prostate carcinoma. J Nucl Med. 2009 Jun;50(6):865-70. doi: 10.2967/jnumed.108.060673. Epub 2009 May 14.

  PMID: 19443579 BACKGROUND

• Krengli M, Ballare A, Cannillo B, Rudoni M, Kocjancic E, Loi G, Brambilla M, Inglese E, Frea B. Potential advantage of studying the lymphatic drainage by sentinel node technique and SPECT-CT image fusion for pelvic irradiation of prostate cancer. Int J Radiat Oncol Biol Phys. 2006 Nov 15;66(4):1100-4. doi: 10.1016/j.ijrobp.2006.06.047. Epub 2006 Sep 11.

  PMID: 16965862 BACKGROUND

• Rousseau C, Rousseau T, Bridji B, Pallardy A, Lacoste J, Campion L, Testard A, Aillet G, Mouaden A, Curtet C, Kraeber-Bodere F. Laparoscopic sentinel lymph node (SLN) versus extensive pelvic dissection for clinically localized prostate carcinoma. Eur J Nucl Med Mol Imaging. 2012 Feb;39(2):291-9. doi: 10.1007/s00259-011-1975-x. Epub 2011 Nov 16.

  PMID: 22086144 BACKGROUND

Related Links

• The University of Western Ontario

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Irina Rachinsky, MD, MSc

  The University of Western Ontario- Nuclear Medicine

  PRINCIPAL INVESTIGATOR

• Albert Driedger, MD, PhD

  The University of Western Ontario - Nuclear Medicine

  STUDY CHAIR

• Joseph Chin, MD, PhD

  The University of Western Ontario- Urology

  STUDY DIRECTOR

• Madeleine Moussa, MD

  The University of Western Ontario - Pathology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: October 16, 2008
• Study Start: April 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 5, 2012

Record last verified: 2012-03

Locations

CA (1)