Prostate Cancer Clinical Trial
Official title:
Essais Clinique Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d'ExérèsE (PERSÉE) appliquée à la Chirurgie de la Prostate
This multicenter study aimed at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during Robotic-Assisted Radical Prostatectomy or Laparoscopic Radical Prostatectomy for intra-operative characterisation of surgical margins.
Prostate cancer is one of the most diagnosed cancer in men. Several treatments are available
depending on patient's clinical features. When the cancer is localised or locally advanced,
one of the possible treatment is Radical Prostatectomy. A risk of that procedure is the
incomplete removal of cancer tissues due to the presence of cancer cells within the resection
margin. A histological analysis of the resected prostate allows to assess surgical margins.
If cancer cells comes out to the edges of the removed tissue, it is called Positive Surgical
Margin (PSM). Several studies showed that PSMs are more frequent in case of extra-prostatic
extensions of the cancer and are correlated with biochemical recurrence.
A study conducted on 21 patients scheduled for Robotic-Assisted Radical Prostatectomy has
already demonstrated the feasibility of the intra-operative observation of microscopic
features of prostatic and periprostatic tissues in vivo and ex vivo with the Cellvizio® 100
Series system combined with the CelioFlex™ probe.
The main objective of the study is to assess the feasibility and safety of pCLE technology
during radical prostatectomy (RP) and to assess the diagnostic performance of pCLE technology
for the definition of the resection margins.
This method could be used to guide surgeons during nerve sparing surgery and provide
real-time feedback for adequate dissection of NVB. As well, ex vivo characterisation of
benign and cancerous glandular structures could provide an efficient and rapid method for
intra-operative surgical margin assessment
The study is divided in 2 parts:
1. Ex vivo study
An ex vivo study will be carried out on 15 firsts prostate specimens for pathologist
training and generation of ex vivo pCLE images atlas.
2. In vivo study
Prior to pCLE analysis, a contrast agent (Fluorescein) will be administered:
- by intravenous injection in each prostatic pedicles before their ligation
- topically, after NVB dissection, in a spray solution through a catheter inserted in an
assistant trocar or with a soaked gauze.
The Cellvizio will be used during the NVB dissection to acquire in vivo images and sequences
of prostatic tissues.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Active, not recruiting |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |