Status:
TERMINATED
SPECT-CT Guided Lymphatic Mapping and Sentinel Lymphadenectomy (LM/SL) in Prostate Cancer
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
London Regional Cancer Program, Canada
University of Western Ontario, Canada
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 majorit...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00773318
Start Date
April 1 2008
End Date
February 1 2012
Last Update
March 5 2012
Active Locations (1)
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1
University Hospital - Dpt. of Nuclear Medicine
London, Ontario, Canada