Phase I Resources Available
Phase II Resources – Tissue Micro-Array Availability
Phase III Resources – Frozen Tissue Availability
Cost Recovery and Priority Access Policy
Recommended Standardised Guidelines for Collection & Storage Procedures - For Prospective Collections
BioResource Tissue Access Policy
who are approached by their treating urologist and agree to donate
specimens are asked to give written informed consent for the tissue
banking protocol. A comprehensive patient information sheet covers
all aspects relevant to the study, ie purpose of collection, how the
tissues and data are collected, risks involved, confidentiality,
patient rights, use of the tissue, and contact persons. The consent
form gives permission for collection of blood and prostate tissue,
and gathering of patient demographics, collection of clinically
relevant information, and tracking of patient progression after
treatment, for inclusion in the BioResource database. Consent is
also obtained where appropriate for application of patient
A blood sample
is usually collected on the day of consenting, or immediately before
surgery. Following radical surgery, prostate tissue is sampled
according to the procedure developed by the participating site in
consultation with the urologists and pathologists concerned. This
method provides the highest quality of surgical pathology for the
patient, while allowing sufficient cancer and non malignant tissue
to be banked for future research. Only after all diagnostic
pathology requirements are met will the tissue be released for
research purposes. Tissue samples are collected prior to tissue
fixation of the prostate. Usually between two to six 5mm or two 8mm
punch biopsy cores, or two scalpel-removed samples are taken
depending on the pathology service and the size of the prostate.
Tissue bank personnel ensure that the donated specimens are frozen
in the shortest possible time after removal of the prostate from the
patient, and this time (preferably within 30 minutes) is recorded
for tissue bank quality control purposes. Long delays in sampling
permit degradation of RNA and cellular membrane proteins due to the
high level of enzyme activity within the prostate.
2005/2006, da Vinci robot-assisted radical prostatectomy was
introduced into several centres in Australia, and the proportion of
radical surgery procedures utilizing this advanced technology is
expected to progressively increase over the next 5-10 years.
Although robotic surgery is of benefit to the patient in terms of
reduced blood loss and shorter stay in hospital, the procedure
results in an increased delay between the severing of the prostate
blood supply and removal of the organ from the patient. This period
of warm ischaemia (lack of oxygen) at body temperature can lead to
changes in cell morphology visible under the microscope, but there
is apparently little adverse effect on mRNA quality at the molecular
level. A study to compare the immunostaining profile of tumour
biomarkers between prostate tissues derived from conventional and
robot-assisted radical prostatectomy is being conducted by the
collection being progressively acquired by the BioResource nodes
comprises prospectively collected fresh frozen prostate tissue,
blood plasma and serum, and white blood (buffy coat) cells. Samples
of ejaculate and post ejaculatory urines for biomarker studies and
isolation of metastatic cells are being collected by researchers in
Brisbane and would be available on a collaborative research basis,
to be arranged via the Project Manager. Tissue Micro-Arrays are
being progressively constructed from paraffin-embedded prostate
cancer blocks extracted from existing pathology archives, where the
tissue blocks may be associated with up to 5-7 year data on clinical
follow up of patient disease outcome.
Phase I Resources Available
Each node has a
collection of frozen and paraffin-blocked tissues that predates the
formation of the BioResource. These collections have Institutional
ethics approval for use in collaborative research with the team of
investigators at the node concerned. Researchers may contact the
National Project Manager with an outline of an ethically approved
project and their tissue requirements. The Project Manager will then
attempt to facilitate collaboration by contacting each node to
determine whether they have the necessary tissue and data resources
Phase II Resources - Tissue Micro-Array
As indicated in the outline of phase II operations of the BioResource (see About Us section), some TMA sets have been released. TMA sets currently available are:
- A human early stage prostate cancer progression array with Gleason score 4-9, and matching non-malignant tissue cores (n = 150 patients). Predominant scores are 6-7 as per natural disease spectrum
- A pilot array with matching malignant and non-malignant cores from 10 men with early stage prostate cancer for initial testing for prostatic expression and optimisation of probe staining
- A normal prostate tissue array with age-related histological change
- Human prostate normal and cancer cell line array
- An array for development of hormone resistance in a transgenic mouse model of prostate cancer (TRAMP)
- A murine pilot array for preliminary testing of prostatic expression and optimisation of probe staining
All TMAs produced by the BioResource use 1mm tissue cores, usually in triplicate, with cancer and control non-malignant tissues from approximately 25-30 patients per block. Access to these resources is granted under the conditions outlined in the Tissue Access Policy document (see below). Partial cost recovery fees are applicable (see below).
Phase III Resources – Frozen Tissue
As indicated in the outline of phase III operations of the BioResource provided in the About Us section, the prospective collection of tissues was initiated at all four nodes between October-November 2005. Also as indicated in the About Us section, release of the stored tissues from any single patient will be staged, with half being released immediately, and half after accumulation of 5 year clinical follow up data.
No prostate tissue samples are released to researchers without a comprehensive pathological review to confirm either non-malignant or malignant status, and if the latter the proportional volume of cancer. The BioResource strives for a quality product. The average RNA Integrity Number (RIN, Agilent Technologies) for 80 individual prostate tissue samples tested is 9.2.
A Priority Access Policy for a reserve collection is in place for tissue contributory groups and other members assisting BioResource operations, for information please consult the Project Manager.
At the end of December 2009 (49 month accrual point), the BioResource prospective collection contained the following for early stage prostate cancer treated by radical surgery:
Number of patients: 2372
Number of patients providing frozen prostate samples: 1416 (60%)
Number of patients providing archived paraffin blocks: 2337 (99%)
Number of patients providing derived blood products: 1577 (66%)
Current rate of patient accrual (December 2009): approx 55 per month
Cost Recovery and Priority Access
A partial cost recovery programme is in place. Fees will be reviewed annually and details can be obtained from the Project Manager.
The full fee structure is payable by researchers not associated with the BioResource tissue collection or management for both frozen prospectively-collected tissues and for paraffin-embedded micro-arrayed tissues, but a discount applies for members of the BioResource. For further information please contact the Project Manager.
In order to conserve the tissue resource, frozen prostate tissue and blood products will be released only to highly rated projects of Australian researchers. Access for commercial / Pharmaceutical / Biotechnology companies, and for overseas researchers will require an Australian collaborator. Please contact the Project Manager for further information.
Current fees until December 2010 are:
Prospectively collected tissues:
Frozen prostate tissue (20 microns supplied as 5 or 10 micron sections) - A$185 per patient sample
Blood products (Guthrie blots, frozen serum (0.5ml), plasma (0.5ml), buffy coat cells (0.2ml) - A$30 per patient sample
Human pilot array: 5 sections provided off a single block for testing of prostatic expression and reagent optimization: A$100
Human test arrays: 1 section off a single block in an array (containing 25-30 patients): A$100 [eg a set of sections, one off each block in a 5-block array (containing a total of 125-150 patients) would cost A$500]. Additional sections or sets of sections may be purchased as required, with approval of the Tissue Access Committee.
Mouse (TRAMP) pilot and test arrays, to be determined, please consult the Project Manager.
Freight for frozen tissues (on dry ice) and microarrays (on wet ice) will be at the current commercial rate from the Institute holding the materials. There may be several freight bills for frozen tissues depending on the institutes from which they are derived.
The Ethics Sub-Committee of the BioResource has reviewed a number of patient information sheets and consent forms approved by local Institutional Ethics Committees (IEC) and in use by the contributing nodes. A proforma for both patient information sheet and consent form can be provided by the Project Manager as a guide for investigators wishing to access materials, and who may need to demonstrate to their IEC the consent under which research tissues have been procured by the BioResource.
Researchers can access the following document either via the link provided below, or by email from the Project Manager
Proforma, participant information sheet
Proforma, participant consent form
Recommended Standardised Guidelines for
Collection & Storage Procedures - For Prospective Collections
These guidelines are
available from the
Tissue Access Policy
The BioResource has
developed a tissue access policy using the guidelines provided by
the NMHRC for tissue banks funded via the Enabling Grant
access copies of the following documents either via the link
provided below, or by email from the Project
Tissue Access Policy
Letters of Intent:
Frozen Prostate tissue
Blood and blood products
Normal prostate array
Normal & prostate cancer cell line array
Material Transfer Agreement