Info sheet for urologists Version 2: 30.01.2012
IMPACT STUDY - BIOPSY INFORMATION FOR UROLOGIST
This information sheet has been written to accompany a referral of a patient taking part in the IMPACT study. The IMPACT study is offering targeted prostate cancer screening (using annual PSA testing) to men from families with BRCA1 or BRCA2 mutations and Lynch syndrome mutations (MSH2, MSH6 and MLH1).
Evidence is mounting that men with BRCA2 mutations are at higher risk of prostate cancer (estimated at 7 times the risk of the general public), that they are being affected at a younger age, and that they have more aggressive disease1,2. There is evidence that men with BRCA1 mutations may also be at a higher risk3-6. Recent research is beginning to suggest that men who have an alteration in one of the Mismatch Repair genes (MSH2, MSH6, MLH1), also called Lynch Syndrome, may be at a higher risk of developing prostate cancer. 7-10
For a copy of the study protocol please contact
The study protocol specifies that:
· Men with a PSA level 3.0ng/ml should undergo a 10 core prostatic biopsy.
· We ask that the normal biopsy consent process is followed
· An IMPACT study biopsy consent form should also be signed by the patient and yourself prior to the procedure.
· Antibiotic and anticoagulant management should follow the local protocol.
· Pathology should be reviewed and reported as normal by the local histopathologist.
· A copy of the histopathology report should be sent to the study team.
· If High Grade PIN is identified at biopsy, it is recommended that the biopsy is repeated after 6 months.
· If Atypical Small Acinar Proliferation (ASAP) is identified at biopsy it is recommended that the biopsy is repeated after 3 months
· For ASAP and high grade PIN it is recommended that an MRI of the pelvis is performed prior to the repeat biopsy to enable any suspicious areas to be targeted (please note the MRI is subject to hospital funding and policy).
· Slides / blocks will be requested for a central review of all pathology for research purposes only.
· Please note that we ask for two additional biopsy cores to be taken for research purposes, and that these should be immediately put into a container (no preservative) and into dry ice until they can be transferred to a -80 freezer.
Thank you for collaborating in the IMPACT study. If you have any questions please contact:
[INSERT LOCAL CONTACT DETAILS]
Please find enclosed:
1. The Biopsy Checklist
2. A copy of the patient’s signed consent form confirming enrolment in the IMPACT study
3. A copy of the study biopsy consent form to be completed prior to the biopsy and providing consent for two additional cores to be taken for research purposes.
References
1. Breast Cancer Linkage Consortium (1999) Cancer risks in BRCA2 mutation carriers. J.Natl.Cancer Inst. 91(15):1310-6.
2. Thomspon D et al (2002) Cancer Incidence in BRCA1 mutation carriers. J Natl Cancer Inst. 94(18):1358-65.
3. Edwards SM et al. (2010) Prostate cancer in BRCA2 germline mutation carriers is associated with poorer prognosis. Br J Cancer. 103(6):918-24.
4. Mitra A et al. (2008) Prostate cancer in male BRCA1 and BRCA2 mutation carriers has a more aggressive phenotype. Br J Cancer. 29;98(2):502-7.
5. Narod SA et al. (2008) Rapid progression of prostate cancer in men with a BRCA2 mutation. Br J Cancer. 99:371-4.
6. Tryggvadóttir L et al. (2007) Prostate cancer progression and survival in BRCA2 mutation carriers. J Natl Cancer Inst. 99:929-35.
7.Grindedal EM, Moller P, Eeles R, et al. Germ-line mutations in mismatch repair genes associated with prostate cancer. Cancer Epidemiol Biomarkers Prev. 2009; 18(9):2460–2467.
8. Barrow P et al, unpublished data;
9. Raymond V et al, unpublished data;
10. Mæhle L et al
IMPACT STUDY: BIOPSY CHECKLIST
Patient Name: ______
ID Number: ______
Patient Study Number: -
Date of Birth: - -
Day Month Year
CORES TAKEN (Please tick):
Please refer to the Processing and Reporting of Prostate Biopsies protocol for more details (Appendix H of the IMPACT study protocol).
LEFT RIGHT
1. Left base 1. Right base
2. Left lateral base 2. Right lateral base
3. Left mid-lateral 3. Right mid-lateral
4. Left mid-sagittal 4. Right mid-sagittal
5. Left apex 5. Right apex
6. Left mid zone periphery 6. Right mid-zone periphery
(FOR RESEARCH)* (FOR RESEARCH)*
* These are suggested sites of biopsy. If there is an area of ultrasound abnormality, please take additional research cores in this area. If this area is large enough, both research cores can be taken from this area.
PROSTATE DIMENSIONS/ cm
Anterior to posterior cm
Left to right cm
Apex to base cm