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

This study has been terminated.
(1 patient has been enrolled. No complications reported. The research team decided to terminate the clinical trial due to insufficient patients' accrual.)
Sponsor:
Collaborators:
London Regional Cancer Program, Canada
University of Western Ontario, Canada
Information provided by (Responsible Party):
Irina Rachinsky, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00773318
First received: July 25, 2008
Last updated: March 2, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Prostate Cancer
Procedure: SPECT/CT guided LM/SL

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: SPECT-CT Guided Lymphatic Mapping and Sentinel Lymphadenectomy (LM/SL) in Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Technical feasibility and clinical utility of LM/SL with SPECT/CT in patients with early stage prostate cancer versus CLND. [ Time Frame: 1 year - 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tolerability, operating time, and complications rate of SPECT/CT guided LM/SL [ Time Frame: 1 year - 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: April 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A

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

Detailed Description:

A multidisciplinary team (urologist, oncologist, radiologist, pathologist, and nuclear medicine) will assess the technical feasibility of LM/SL with SPECT/CT as well as its clinical potential for the staging of regional lymph nodes in 30 consecutive patients with AJCC stages I-II-III prostate cancer scheduled for prostatectomy and pelvic lymph node dissection according to the standards of care.

This is a 2-day protocol with a single isotopic tracer (Tc99m-cysteine rhenium colloids, 10-15 nm). The tracer injections will be performed under trans-rectal ultra-sound guidance (1 inj/lobe, 74MBq, 0.2 cc).

The first day or injection day (D0), an early imaging session with planar acquisitions (anterior and posterior views) will be performed within 30 min post-tracer injection. A delayed imaging session with planar and SPECT/CT acquisitions will be also performed 1 to 3 hours after tracer injection. The SPECT/CT device to be used in this research protocol is the Infinia Hawkeye 4-slice from GE Healthcare. This hybrid camera incorporates a low-dose CT with a 2.5 mA current (eff.dose < 2mSv) on a dual-head gamma camera. SPECT/CT data will be analysed on the Xeleris 2.05v (Volumetrix for Hawkeye Oncology).

The second day (D+1 post-tracer injection), all prostate cancer patients will undergo a radical prostatectomy with complete pelvic lymph node dissection (CLND). Sentinel lymph nodes (SLNs) will be detected intra-operatively by using a gamma probe (Navigator, Tyco Healthcare). In this single tracer study, SLNs are defined as hot nodes only including the hottest node and any hot node ≥ 10% of the hottest node. In this SPECT/CT protocol, additional non-radioactive nodes eventually detected on the CT component and suspicious of tumor involvement (lymphadenopathies > 1cm) will be also removed, especially lymph nodes located in unpredictable lymphatic basins. Surgery will be performed by the same surgeons.

SLNs and non-SLNs will be analyzed by the same pathologist. For SLNs, a Hematoxylin & Eosin staining (H-E) will be firstly performed. If negative, 3 more H-E stains levels will be performed and immuno-peroxidase stains for Cytokeratins AE1/AE3, PSA, and PAP. Non-SLNs will be analyzed according to the routine protocol with 3 H-E stained levels only. The SLN features will be noted: number, anatomical localization in vivo, counting rates ex vivo. The pathological characteristics of metastatic SLNs and non-SLNs will be precisely recorded: size, involvement (micro-metastases ≤ 2mm; macro-metastases; isolated tumor cells), % of nodes involved (small < 25%; moderate = 25-75%; massive > 75%).

  Eligibility

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773318

Locations
Canada, Ontario
University Hospital - Dpt. of Nuclear Medicine
London, Ontario, Canada
Sponsors and Collaborators
Lawson Health Research Institute
London Regional Cancer Program, Canada
University of Western Ontario, Canada
Investigators
Principal Investigator: Irina Rachinsky, MD, MSc The University of Western Ontario- Nuclear Medicine
Study Chair: Albert Driedger, MD, PhD The University of Western Ontario - Nuclear Medicine
Study Director: Joseph Chin, MD, PhD The University of Western Ontario- Urology
Study Director: Madeleine Moussa, MD The University of Western Ontario - Pathology
  More Information

Additional Information:
Publications:

Responsible Party: Irina Rachinsky, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00773318     History of Changes
Other Study ID Numbers: R-06-433, 12638
Study First Received: July 25, 2008
Last Updated: March 2, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
LM/SL
SPECT/low-dose multislice CT

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014