Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection (Bio-Prost)

Grenoble Alpes University Hospital Center (CHU)

Status: Terminated

Conditions: Cancer Prostate

Treatments: Other: Fluorescence assessment

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT03157856

38RC17.019

Details and patient eligibility

About

In this study, we aim to evaluate the feasibility of anti-PSMA labelling to detect post-operative prostatic tissues by two ex vivo fluorescence techniques. We will evaluate the feasibility and detection of anti-PSMA labelling by:

1. / the FEMTO-ST institute medical device,
2. / the confocal microscope that will be used to measure fluorescence spectra of biological samples.

Full description

For this protocol, 12 patients will be included.

Enrollment: 8 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male patient over 18 years old

• patient with indication for radical prostatectomy

• patient with a rectal palpable nodule or targeted MRI positive biopsies or with at least 4 positive biopsies in a hemi-prostate.

  • patient affiliated to French social security system or equivalent
  • patient who have signed a non-opposition form

Exclusion criteria

• patient with contraindication to radical prostatectomy
• patient with remedial prostatectomy
• patient with normal preoperative MRI or with absence of tumoral area
• patient with history of hormonal therapy
• person deprived of freedom by judicial or administrative decision
• person under legal protection
• person hospitalized for psychiatric care.

Trial design

8 participants in 1 patient group

Experimental: fluorescence assessment

Description:

Medical device: Use of the FEMTO-ST institute medical device to detect prostatic and non prostatic tissue.

Treatment:

Other: Fluorescence assessment