Prostate Cancer Clinical Trial
Official title:
In-vivo Focal Prostate Imaging With Confocal Laser Endomicroscopy and Optical Coherence Tomography
The current limitations in prostate cancer diagnostics lead to over- and undertreatment for a
significant fraction of patients. Confocal Laser Endomicroscopy (CLE) and Optical Coherence
Tomography (OCT) are focal imaging modalities with potential for in-vivo prostate imaging.
The investigators anticipate that integrating focal imaging with MRI/TRUS fusion will further
improve prostate cancer detection and provides a real-time histopathological threedimensional
representation of the tumor lesions.
This is an investigator-initiated, prospective in-vivo safety and feasibility study with
transperineal template mapping biopsies (TTMB) and two focal imaging methods, CLE and OCT, in
prostate tissue.
Study design:
This is an investigator-initiated, prospective in-vivo safety and feasibility study with two
procedures.
Procedure 1 (AMC):
Patients that are indicated for transperineal template mapping biopsies (TTMB) are included
for procedure 1 and will receive transperineal CLE or OCT measurements prior to TTMB.
Procedure 1 is to test the technical feasibility and safety of in-vivo focal imaging with CLE
and OCT. Only if transperineal CLE or OCT measurements are possible, the investigators
proceed with procedure 2.
For procedure 1: 4 patients that are scheduled for TTMB; 2 patients for CLE and 2 patients
for OCT.
Procedure 2 (VUmc):
Patients scheduled for a robot-assisted laparoscopic prostatectomy (RALP) will be included in
procedure 2 and receive transperineal CLE or OCT measurements prior to their surgery. Results
will be correlated with histology by correlating biopsies during the TTMB procedure or with
RALP the measurement trajectory will be marked. After the RALP, the prostate will be cut
exactly through the measurement trajectory for whole mount coupes. In high-risk of
high-intermediate-risk patients receiving an extended pelvic lymph node dissection with the
RALP, ex-vivo CLE measurements will be performed.
For procedure 2: 10 patients that are scheduled for RALP; 5 patients for CLE and 5 patients
for OCT. Intervention: Transperineal CLE or OCT measurements will be performed directly prior
to the TTMB or RALP. The CLE and OCT probes are inserted by a needle with the same diameter
as a biopsy gun. In the case of RALP, measurement trajectories will be marked for
histopathology correlation.
Intervention:
Transperineal CLE or OCT measurements will be performed directly prior to the TTMB or RALP.
The CLE and OCT probes are inserted by a needle with the same diameter as a biopsy gun. In
the case of RALP, measurement trajectories will be marked for histopathology correlation.
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