None listed
Conditions
Brief summary
The primary purpose of the trial is to assess the effectiveness and safety of a new method for parallel harvesting, processing and analysis of prostate biopsy cores using a new grooved organic matrix, HistoBest Biopsy Chip(TM) (patent pending). The current hypothesis is that use of this matrix will improve prostate cancer histopathology diagnosis, in several ways: - by facilitating and encouraging a systematic biopsy approach - by reducing time and material expenses in processing and analysis of histopathology samples - by allowing a precise location of the tumor and its extension, because information pertaining to the location and orientation of each biopsy core within the prostate is preserved. Another goal of the study is to establish a comprehensive tissue archive in view of further studies, such as screening for retroviruses, genetic susceptibility and somatic mutations in prostate cancer.
Interventions
prostate cancer diagnosis via systematic TRUS-guided prostate biopsy (once per patient, lasting ~ 20 min):
- prostate samples are harvested via systematic TRUS-guided biopsy using a Bard MAGNUM (Registered trademark) biopsy gun (Bard Biopsy Systems Inc., Tempe, AZ, USA) and 18G x 20 mm core tissue biopsy needles;
- local anesthesia is achieved by intrarectal application of 2% lidocaine gel, without periprostatic nerve block;
- in selected cases antibiotic prophylaxis is used, consisting in sin
prostate cancer diagnosis via systematic TRUS-guided prostate biopsy (once per patient, lasting ~ 20 min): - prostate samples are harvested via systematic TRUS-guided biopsy using a Bard MAGNUM (Registered trademark) biopsy gun (Bard Biopsy Systems Inc., Tempe, AZ, USA) and 18G x 20 mm core tissue biopsy needles; - local anesthesia is achieved by intrarectal application of 2% lidocaine gel, without periprostatic nerve block; - in selected cases antibiotic prophylaxis is used, consisting in single dose fluoroquinolone derivatives or amoxicillin administered before the procedure; - up to 14 biopsy cores per patient are extracted and placed in a HistoBest Biopsy Chip (Trademark) matrix in grooves at specified positions and in the same orientation with respect to the entry point of the biopsy needle; - the location of each core is marked with a number on a prostate diagram map for each biopsy protocol sheet, allowing unambiguous and easy location of the tumor and estimation of its size and extension.
Sponsors
MedNewLife Medical Center
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
clinical/biochemical suspicion of prostate cancer (positive digital rectal examination - DRE and/or prostate specific antigen - PSA >= 2.5 ng/ml)
Exclusion criteria
There are no exclusion criteria
Outcome results
None listed