Clinical trial · Interventional
SPECT-CT Guided Lymphatic Mapping and Sentinel Lymphadenectomy (LM/SL) in Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 1 patient has been enrolled. No complications reported. The research team decided to terminate the clinical trial due to insufficient patients' accrual.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPECT/CT guided LM/SL | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- 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
- interventionNames
- Procedure: SPECT/CT guided LM/SL
Primary outcomes (1)
- measure
- Technical feasibility and clinical utility of LM/SL with SPECT/CT in patients with early stage prostate cancer versus CLND.
- timeFrame
- 1 year - 2 years
Secondary outcomes (1)
- measure
- Tolerability, operating time, and complications rate of SPECT/CT guided LM/SL
- timeFrame
- 1 year - 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDWeckermann 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
- BACKGROUNDCorvin 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
- BACKGROUNDKizu 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
- BACKGROUNDSchumacher 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
- BACKGROUNDWeckermann 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
- BACKGROUNDScardino 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
- BACKGROUNDde 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.