Protocol for Conducting a finger-prick Prostate Specific Antigen Test

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1 Cancer Assciatin f Suth Africa (CANSA) Prtcl fr Cnducting a finger-prick Prstate Specific Antigen Test It has been apprved that staff in the varius CANSA Business Units may cnduct the fllwing finger-prick PSA test as part f CANSA s Men s Health Prgramme: PSA Ultra Prstate Specific Antigen Semi-Quantitative Rapid Test Single Use Kit (Whle Bld/Serum/Plasma) Intrductin The prstate gland is part f the male reprductive system. It is a rund gland, abut the size f a pea shaped at birth and has the size and shape f walnut in an adult. It lies in the pelvic cavity immediately in frnt f the rectum. It surrunds the cmmencement f the urethra (urinary tube) at the base f the urinary bladder. It prduces seminal fluid that assists in transprting the sperm during ejaculatin. Prstate cancer is ne f the leading cancers in males wrldwide. Prstate cancer is currently the secnd mst cmmn malignancy in Black men in Suth Africa and the mst cmmn malignancy in White men in Suth Africa (excluding skin cancer). Incidence f Prstate Cancer in Suth Africa The fllwing Suth African statistics regarding histlgically diagnsed cases f prstate cancer during 2008 are available frm the Natinal Cancer Register (2008): The fllwing Suth African statistics regarding prstate cancer are available frm the Natinal Cancer Register (2008): Nvember 2014 Page 1

2 Grup N f Cases Lifetime Risk All males :26 Asian males 111 1:32 Black males :44 Clured males 511 1:18 White males :8 The frequency f histlgically diagnsed cases f prstate cancer in Suth Africa fr 2008 was as fllws (Natinal Cancer Register, 2008): Grup All males Asian males Black males Clured males White males Prstate cancer is caused by changes in the DNA f a nrmal prstate cell. DNA makes up the genes, which cntrl hw cells behave. DNA is inherited frm ne s parents. A small percentage (abut 5 t 10%) f prstate cancers are linked t these inherited changes (American Cancer Sciety). Research shws that men with BRCA1/2 mutatins were mre likely than nn-carriers t be diagnsed with advanced-stage prstate cancer r cancer that had already spread. Like with mst cancers, the cause f prstate cancer is nt knwn. Hwever, there are knwn factrs which have been determined thrugh research that increases the risk f men develping prstate cancer. Guidelines fr Having a PSA Test Rutine Prstate Specific Antigen (PSA) testing, at least nce every tw (2) years, fr all males frm age 50 is recmmended. Men between the ages f 40 and 50 shuld cnsider having a PSA test dne: If they have a family histry f prstate cancer If they have any f the early r late warning signs f prstate cancer It is nt recmmended t cnduct rutine PSA testing f males ver the age f 70 r any man with less than a 10- t 15-year life expectancy unless there are specific indicatins t d s (WebMD). Risk Factrs fr Prstate Cancer Risk factrs fr prstate cancer include: Age: it ccurs mre frequently in lder men Family histry: there is ften a histry f a brther r father wh had prstate cancer Nvember 2014 Page 2

3 Lifestyle: high fat intake, lw cnsumptin f vegetables, besity, lack f physical activity, and smking Prstate cancer develps in the tissues f the prstate gland and usually grws slwly in cmparisn with ther types f cancer Early Warning Signs f Prstate Cancer Early warning signs f prstate cancer include: Difficulty in passing urine A slw stream, ften with dribbling at the end Inability t start r stp the flw f urine Frequent need t pass urine, especially at night The symptms may be related t ther factrs such as inflammatin f the prstate gland called prstatitis r enlargement f the prstate gland (benign prstate hyperplasia) r benign prstatic hypertrphy which are nn-cancerus. Late Warning Signs f Prstate Cancer Late warning signs f prstate cancer include: Inability t pass urine Lwer back pain Bld in the urine r semen Painful ejaculatin Erectile dysfunctin Weight lss Prstate Specific Antigen (PSA) Prstate Specific Antigen (PSA) is made by the prstate gland. Sme f it will leak int yur bld, and the amunt depends n yur age and the health f yur prstate. Just as imprtant as the PSA number is the trend f that number (whether it is ging up, hw quickly, and ver what perid f time). It is imprtant t understand that the PSA test is nt perfect. [Picture Credit: PSA Test] Raised PSA levels The amunt f PSA in yur bld is measured in nangrams f PSA per millilitre f bld (ng/ml). PSA levels can range frm 1ng/ml t hundreds f ng/ml. A patient aged 50 59, the PSA level is cnsidered raised if it is 3ng/ml r higher A patient aged 60 69, the PSA level is cnsidered raised if it is 4ng/ml r higher A patient aged 70 r ver, the PSA level is cnsidered raised if it is 5ng/ml r higher Nvember 2014 Page 3

4 A raised PSA level in the bld may shw that the individual has a prblem with his prstate. Hwever, this may nt be prstate cancer. An urinary tract infectin may als cause a raised PSA. Key statistics Abut 15% f all men with a 'nrmal' PSA level (under 4ng/ml) may have prstate cancer. Tw ut f three men with a raised PSA level d nt have prstate cancer. One ut f three men with a raised PSA level will have cancer. Tw ut f three men wh have a bipsy d nt have cancer. Bipsies in ne in five men fail t spt prstate cancer. Other cnditins, such as an enlarged prstate, prstatitis (inflammatin f the prstate), r a urinary infectin, can als cause a raised PSA level. (NHS Chices; ehw; WebMD; Prstate Cancer UK). Things that Culd Raise the PSA Result PSA is prduced by healthy cells in the prstate - it is, therefre, nrmal fr all men t have a small amunt f PSA in their bld. There are ther things that can raise yur PSA level. A urinary tract infectin the patient must receive treatment fr any infectin, and will need t wait arund fur t six weeks until the infectin has cleared up befre he has a repeat PSA test Vigrus exercise especially cycling in the 48 hurs befre a PSA test Ejaculatin in the 48 hurs befre a PSA test Anal sex and prstate stimulatin if the persn is gay, bisexual r a man wh has sex with men, being the receptive partner during anal sex might raise the PSA level. Having the prstate stimulated during sex might als raise the PSA level. It might be wrth aviding this fr a week befre a PSA test A digital rectal examinatin (DRE) befre a PSA test might raise the PSA level A prstate bipsy in the six weeks befre a PSA test Other investigatins r peratins n the bladder r prstate, r having had a urinary catheter passed. The patient may need t wait up t six weeks after these prcedures befre having a repeat PSA test Medicatins that Culd Lwer the PSA Reading and Cause a False Negative Result Finasteride (MK-906, Prscar and Prpecia) is a 5 alpha-reductase inhibitr. It wrks in the prstate by blcking the cnversin f teststerne t dihydrteststerne. This blcking f dihydrteststerne frmatin leads t decreases in prstate vlume, which in turn leads t a lwer level f PSA in the serum. In the prstate cancer patient, men wh tk finasteride had a 50% decrease in serum PSA level after 1 year f treatment. Therefre, if a patient was taking a 5 alpha-reductase inhibitr such as finasteride (Prscar) r dutasteride (Avdart) fr even 1 year, his PSA level wuld need t be adjusted by multiplying the current value by 2. A man taking finasteride fr a full 4 years shuld have his PSA level multiplied by 2.3 befre cmparing it with standard reference ranges. (MedScape). Nvember 2014 Page 4

5 Different Ways f Lking at Prstate Specific Antigen (PSA) Prstate Specific Antigen, r PSA fr shrt, is a prtein that is prduced by prstate cells. The PSA increases as men age, when the prstate enlarges r becmes inflamed and when prstate cancer is present. There are als transient bumps in PSA after, fr example, digital rectal examinatin (DRE), ejaculatin, and bike riding. PSA is prstate specific but nt cancer specific. There are different ways in which t lk at a PSA result. Abslute Value - when PSA was intrduced a cut ff f 4.0 was used t achieve what scientists and dctrs felt t be an acceptable level f sensitivity (hw many it catches) and specificity (hw accurate it is if psitive). It was sn realised that althugh this was helpful it missed t many cancers in yung men and resulted in t many bipsies and ver diagnsis in lder men. Age Based PSA it is knwn that PSA rises as ne ages. By having a lwer cut ff in yunger men and a higher cut ff in lder men ne is able t catch cancers sner in the yunger ppulatin while eliminating a lt f unnecessary bipsies in the lder ppulatin. There are several accepted reference ranges; ne f the mst cmmn is this: Age Abnrmal Value in < < < 4.5 >75 <6.5 Free and Ttal PSA - while PSA is a prtein that is in the bld stream it is nt all existing in the same frm. Sme is free flating and sme is bund t ther prteins. It was fund that benign disease (nt cancerus) tends t have higher levels f free PSA (>25%) and patients with prstate cancer tend t have lwer free PSA (<15%). These numbers can help stratify the risk in sme men. Fr example if a patient has a PSA f 8.0 and had a negative bipsy, knwing that he has a PSA free >25% gives ne mre assurance that he des nt have prstate cancer. PSA Density it is als knwn that PSA rises as the prstate gets larger. Men with large prstate glands tend t have higher PSA s. A nrmal size prstate is abut 25 grams. One wuld cnsider anything larger than 40 grams an enlarged prstate. A nrmal PSA density is 0.1 PSA fr every gram. This makes sense as a large, 40 gram prstate wuld have a crrespnding upper limit PSA f 4.0. This helps ne in men wh have had a negative bipsy and have enlarged prstate glands. One is then less likely t wrry abut smene with a PSA f 6.0 if their prstate is > 60 grams. Cnversely, ne wuld be mre wrried if the PSA is elevated in a smaller prstate (PSA f 4.2 in a 17 gram prstate). PSA Velcity - ne f the mst accurate ways f diagnsing prstate cancer is lking at the rate f rise f PSA. A PSA shuld never g up mre than 0.7 pints per year. Fr example, it wuld prbably be better t have a PSA cunt ver 3 checks g frm 5.0 t 5.1 t 5.2 than it wuld be t have the PSA cunt g frm 1.0 t 2.0 t 4.0. Nvember 2014 Page 5

6 In summary - Prstate Specific Antigen is nly a tl. It is far frm perfect but it is useful when the patient and his physician wrk tgether t make shared decisins. Since the nset f PSA screening the death rate frm prstate cancer has almst been cut in half. Prstate Cancer is still a high cancer killer f men. There is still much t be learned. Getting as much infrmatin as pssible and making shared decisins with ne s dctr will help t understand the risks and benefits f checking ne s PSA and what t d with the infrmatin. (Rsce Nelsn, 2014). Advantages and Disadvantages f Having a PSA Test There are bth advantages and disadvantages that shuld be cnsidered befre a patient agrees t having a PSA test dne. It s imprtant yu think thrugh the advantages and disadvantages f the PSA test. Having a PSA test is a persnal decisin what might be an advantage fr ne man may nt be fr anther. Advantages f a PSA Test A PSA test can help pick up prstate cancer befre any symptms appear A PSA test may help t pick up a fast-grwing cancer at an early stage when treatment may stp the cancer spreading and causing prblems Slw-grwing prstate cancer might nt need treatment. The patient might be able t have regular check-ups, including PSA tests, t keep an eye n the cancer. This can avid r delay the side effects f treatment Having regular PSA tests culd be helpful fr men wh are mre at risk f prstate cancer. This can help spt any changes in the PSA level, which might be a sign f prstate cancer. Mre research is needed t shw hw ften ne might need a test. Disadvantages f a PSA Test The patient might have a raised PSA level, even if he des nt have prstate cancer. Arund three quarters f men (76 per cent) with a raised PSA level d nt have prstate cancer If the PSA level is raised the persn may need mre tests, including a bipsy. The bipsy has sme risks, such as pain, infectin and bld in the urine and semen. Up t 3 in 50 men (six per cent) may get a serius infectin after a bipsy The PSA test can miss prstate cancer. 1 in 50 men (tw per cent) with fast-grwing prstate cancer have a nrmal PSA level The patient might be diagnsed with a slw-grwing prstate cancer which wuld never have caused him any prblems r shrtened his life. But being diagnsed with cancer culd make him wrry, and he might decide t have treatment that he did nt need Treatments fr prstate cancer have side effects which can affect ne s daily life. These include urinary and bwel prblems, and prblems getting and keeping an erectin (Prstate Cancer UK). Nvember 2014 Page 6

7 Prtcl fr Cnducting a PSA Rapid Screening Test The fllwing prtcl shuld be fllwed: Participants: must sign an indemnity declaratin that prvides prtectin fr CANSA and its staff are t be infrmed that the test is a screening test nly and that the manufacturers claim a 98% accuracy f test results must be cunselled n what a psitive test result entails must als be cunselled n what a negative test result entails must be cunselled bth n a pre- and pst-test basis must be specifically cunselled if they have a PSA test result f 4 r higher, making it clear that this des nt mean that they necessarily have been tested psitive fr prstate cancer but that it culd merely be an indicatin f sme ther frm f prstate inflammatry cnditin (prstatitis), benign prstatic hyperplasia (enlarged prstate), an urinary tract infectin, r merely because they are mre mature (45 years ld r lder) must be specifically cunselled that, even if they have a lw PSA test result (3 r lwer) but have any f the abvementined warning signs, the pssibility f prstate cancer cannt be ruled ut cmpletely and that they shuld visit a medical practitiner t have a serum PSA test as well as a digital rectal examinatin (DRE) [Picture Credit: Serum PSA Test] must be referred t their regular medical practitiner fr fllw-up in the event f a PSA result f 4 r higher must be referred t their regular medical practitiners fr fllw-up if they have a PSA result f 3 r lwer tgether with any f the abvementined warning signs residing in remte r rural areas wh have a PSA test result f 4 r higher, shuld have a serum PSA test cnducted and be referred t their nearest health care facility with a referral letter tgether with the PSA test result Medical Disclaimer This Prtcl is intended t prvide general infrmatin nly and, as such, shuld nt be cnsidered as a substitute fr advice, medically r therwise, cvering any specific situatin. Users shuld seek apprpriate advice befre taking r refraining frm taking any actin in reliance n any infrmatin cntained in this Prtcl. S far as permissible by law, the Cancer Assciatin f Suth Africa (CANSA) des nt accept any liability t any persn (r his/her dependants/estate/heirs) relating t the use f any infrmatin cntained in this Prtcl. Whilst the Cancer Assciatin f Suth Africa (CANSA) has taken every precautin in cmpiling this Prtcl, neither it, nr any cntributr(s) t this Prtcl can be held respnsible fr any actin (r the lack theref) taken by any persn r rganisatin wherever Nvember 2014 Page 7

8 they shall be based, as a result, direct r therwise, f infrmatin cntained in, r accessed thrugh, this Prtcl. Nvember 2014 Page 8

9 Surces and References ehw MedScape NHS Chices Prstate Cancer UK PSA Test Serum PSA Test WebMD Nvember 2014 Page 9

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