Prostate HistoScanning for the Non-invasive Detection and Staging of Prostate Cancer and Characterization of Prostate Tissues (PHS-02)

Advanced Medical Diagnostics

Status: Completed

Conditions: Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01191931

CR2P00113

Details and patient eligibility

About

Study design:

-The study will be a phase I like study to assess the extent to which prostate HistoScanning (PHS, the index test) can identify and characterize foci of prostate cancer when compared to histological samples harvested during radical prostatectomy (the reference test). The study will comprise 3 steps: first, defining the most suitable method for matching the TRUS (TransRectalUltrasonography) to histology (step 1); second, refining the algorithms (training set); third, verification of the PHS performances (test set).

Study objectives:

• Primary Objective:

  • To evaluate the extent to which PHS can discriminate between malignant lesions of the prostate versus non-malignant tissue in 3D RF TRUS data using radical prostatectomy histological step sectioning as the reference test.

• Secondary Objectives:

  • To adapt and refine PHS tissue characterisation algorithms using RF data that were previously developed using grey-level data as input.
  • To assess the accuracy of PHS in predicting the volume of prostate cancers determined by histology.
  • To assess the ability of PHS to rule in or rule out the presence of cancer > or = 0.5 cc and of > or = 0.2 cc as determined by histology.
  • To evaluate the ability to discriminate primary Gleason pattern 4 and 5 versus 3 or less in tumours > or = 0.5 cc and > or = 0.2 cc.
  • To assess the ability of PHS to correctly risk stratify patients.

Enrollment: 52 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: >or=18 year-old
• Histologically (positive biopsy) proven prostate cancer with primary and secondary Gleason patterns attributed.
• Patient planned to undergo radical prostatectomy
• Prostate cancer is deemed to be organ confined (T1-T2, Nx or No, Mx or Mo)
• No prior treatment for prostate cancer, including any type of hormonal therapy
• No major calcification is noted during the TRUS (i.e. (Diameter >or=5 mm, spread all over the prostate or blocking to much of the ultrasound signal).
• Patient willing to give written informed consent

Exclusion criteria

• Patients who are either unsuitable or unwilling to enter the study or to proceed to surgical investigation.

Trial design

52 participants in 1 patient group

prostate cancer

Description:

Patients with histologically proven prostate cancer (positive biopsy) and who are planned to undergo radical prostatectomy.