Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001242910
Ethics application status
Approved
Date submitted
28/11/2011
Date registered
6/12/2011
Date last updated
16/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Establishing a comprehensive tissue archive for multi-center prospective longitudinal and cohort studies - Step 1: Prostate cancer - Validation of the HistoBest Biopsy Chip(TM) (patent pending) as a diagnostic tool and enabling technology in the screening for retroviruses, genetic susceptibility and somatic mutations
Scientific title
Evaluation by histopathology examination and immunohistochemistry on TRUS-guided prostate biopsy samples of the presence, location, extension and grade of tumor (Gleason score) in patients with suspicion of prostate cancer
Secondary ID [1] 273483 0
NONE
Universal Trial Number (UTN)
U1111-1126-0992
Trial acronym
STOPCANCER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 279273 0
Condition category
Condition code
Renal and Urogenital 279471 279471 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 283801 0
Diagnosis / Prognosis
Intervention code [2] 283808 0
Treatment: Surgery
Comparator / control treatment
histopathology examination + immunohistochemistry for p63 and Alpha-Methylacyl-CoA Racemase (AMACR) primary antibodies (once only per patient, lasting 3 days):

- processing of biopsy-loaded matrices is performed in a standardized fashion, and consists in: fixation for 24 +/- 2 hours with 0.2 M phosphate-buffered 4% formaldehyde (pH 7.5), dehydration in graded ethanols, optional storage in buthanol, clarifying in transition solvents, infiltration and embedding in paraffin, semi-serial sectioning at 4-5 mm, mounting on positively charged glass slides, and classical hematoxylin-eosin or immunohistochemistry staining
Control group
Active

Outcomes
Primary outcome [1] 286039 0
presence of cancer (Y/N)
Timepoint [1] 286039 0
at diagnosis
Secondary outcome [1] 295025 0
location of cancer (location of positive prostate biopsy cores)
Timepoint [1] 295025 0
at diagnosis
Secondary outcome [2] 295026 0
extension of cancer (in mm and % of length of each biopsy core)
Timepoint [2] 295026 0
at diagnosis
Secondary outcome [3] 295027 0
grade of cancer (Gleason score)
Timepoint [3] 295027 0
at diagnosis

Eligibility
Key inclusion criteria
clinical/biochemical suspicion of prostate cancer
(positive digital rectal examination - DRE and/or
prostate specific antigen - PSA >= 2.5 ng/ml)
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusion criteria

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 3981 0
Romania
State/province [1] 3981 0

Funding & Sponsors
Funding source category [1] 284275 0
Commercial sector/Industry
Name [1] 284275 0
HistoBest Diagnostics S.R.L.
Country [1] 284275 0
Romania
Primary sponsor type
Commercial sector/Industry
Name
MedNewLife Medical Center
Address
Str. Romulus 57, Bucharest
Country
Romania
Secondary sponsor category [1] 283227 0
Commercial sector/Industry
Name [1] 283227 0
Genetic Lab
Address [1] 283227 0
Blvd. Ghencea 43B, Bucharest
Ghencea Business Center, 3rd floor
Country [1] 283227 0
Romania

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286236 0
Local Ethics Committee, "Carol Davila" Central Military Emergency University Hospital, Bucharest
Ethics committee address [1] 286236 0
"Carol Davila" Central Military Emergency University Hospital
Str. Mircea Vulcanescu 88, Bucharest
Ethics committee country [1] 286236 0
Romania
Date submitted for ethics approval [1] 286236 0
11/07/2011
Approval date [1] 286236 0
14/07/2011
Ethics approval number [1] 286236 0
104/14/07/2011

Summary
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.
Trial website
Trial related presentations / publications
Musat S., Farcas C.P., Dumitrescu M., Amuzescu B., Mischianu D.: A multiplex system for processing and analysis of prostate biopsies. Romuro 2011- the 27th National Urology Congress, Timisoara, 26-27 oct 2011, abstract p. 9

Farcas, C.P., Dinu M., Ilie C.P., Madan V., Popescu R., Spinu D., Amuzescu B., Mischianu D.: The statistical and clinical importance of ERSPC risk indicator in the management of patients with prostate cancer. Romuro 2011- the 27th National Urology Congress, Timisoara, 26-27 oct 2011, abstract p. 8

Amuzescu B., Farcas C., Mischianu D., Musat S.: A new method for simultaneous processing and analysis of prostate core biopsies, Eur. Urol. - manuscript in preparation
Public notes

Contacts
Principal investigator
Name 33451 0
Address 33451 0
Country 33451 0
Phone 33451 0
Fax 33451 0
Email 33451 0
Contact person for public queries
Name 16698 0
Catalin Farcas
Address 16698 0
"Carol Davila" Central Military Emergency Hospital, Str. Mircea Vulcanescu 88, Bucharest
Country 16698 0
Romania
Phone 16698 0
+40 (0) 722 228 392
Fax 16698 0
+40 (0) 21 315 51 11
Email 16698 0
[email protected]
Contact person for scientific queries
Name 7626 0
Sorin Musat
Address 7626 0
HistoBest Diagnostics S.R.L.
Blvd. Carol I 24, Bucharest
Country 7626 0
Romania
Phone 7626 0
+40 (0) 768 73 51 94
Fax 7626 0
+40 (0) 21 326 39 96
Email 7626 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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