Urology - Oncology
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Commentary by Arno Housman, MD, a urologist’s perspective
The goal of screening for prostate cancer is to identify localized disease that can be successfully treated before it becomes advanced and metastatic. Testing men for prostate cancer has become a controversial topic due to a significant percentage of false positive blood prostate-specific antigen (PSA) results leading to invasive testing that may potentially have negative effects on health. In addition, in most men prostate cancer is a disease that may slowly become symptomatic, potentially longer than the person’s life expectancy. This is balanced against the improvement in mortality and symptoms that can be obtained from early diagnosis and treatment of aggressive forms of prostate cancer.
This article will look at the latest guidelines and consensus opinions regarding screening asymptomatic patients for prostate cancer and the benefits and risks of testing and follow-up procedures.
Prostate Cancer Statistics
In the United States, the lifetime risk of contracting prostate cancer is estimated to be 12.6% and the risk of dying from it is 2.5%. There were an estimated 268,490 new cases and 34,500 deaths from prostate cancer in 2022, the fifth leading cause of death in men.[1] The median age of death from prostate cancer is estimated to be 80 years of age and two-thirds are over 75 years of age. Black men have a higher risk of death from prostate cancer of 4.2% compared to white men where the risk is 2.3%.[2]
Many men with prostate cancer never are diagnosed. In autopsy studies of men aged 70 to 79, who died of other causes, 21.2 % of Asians, 36% of whites and 51% of Blacks were found to have undiagnosed prostate cancer.[3] Undetected prostate cancer was also found on autopsy in younger men; 22% of men 50-59 years old and 29% of men 60-69 years old.[3] Mortality depends on whether the cancer is low grade, localized and slow growing or an aggressive form of prostate cancer. The much higher autopsy percentages of undiagnosed prostate cancer compared to clinically diagnosed cases suggests that there is a large pool of silent, slow growing tumors that may not cause symptoms in a man’s lifetime, but if tested for and treated may possibly result in morbidity from invasive procedures.[4]
Rectal exams
Palpating the prostate gland to feel for signs of malignancy by a digital rectal exam has been a time-honored part of the annual physical examination. A systematic review of the literature found that when performed by general practitioners the sensitivity of the rectal exam for prostate cancer was 28.6% and if the exam was normal there was still a 15.8% chance that the patient had prostate cancer. The authors recommended that any patient with symptoms suggestive of prostate cancer be investigated further regardless of the rectal exam results.[5]
Another study found that the rectal exam was not a sensitive tool when compared to blood testing in discovering prostate cancer in men under 50 years of age.[6]
Both the US Preventive Services Task Force (USPSTF) and the American Association of Family Practitioners (AAFP) guidelines recommend not performing a digital rectal exam for asymptomatic prostate cancer screening due a lack of evidence of the benefit.[2,7]
Prostate-specific Antigen Testing
Testing for prostate cancer is done by measuring prostate-specific antigen (PSA) in the blood. There can be false positives from benign prostatic hyperplasia, prostatitis, urologic procedures, taking testosterone and recent ejaculation may also increase the PSA level for a short time. As men age, PSA levels normally increase even without cancer.[2]
The standard screening PSA test used is a total blood PSA level. There is no specific cutoff point of PSA that can accurately diagnose prostate cancer. Many clinicians use a PSA level of 4 nanograms per milliliter (ng/mL) or higher when deciding if a patient might need further testing, while others might recommend further testing at a lower level, such as 2.5 or 3 ng/mL.[8]
Most men without prostate cancer have PSA levels under 4 ng/mL. A level below 4 ng/ml is not a guarantee that a man doesn’t have cancer and about 12%-23% of men with a PSA below 4 will be found to have prostate cancer by biopsy.
Men with a PSA level between 4 and 10 ng/mL have about a 25% chance of having prostate cancer.
Men with a PSA level above 10 ng/mL have over a 50% chance of having prostate cancer.[8,9]
PSA occurs in two major forms in the blood. One type is attached to blood proteins, while the other circulates as a free form. Another test used is the percent-free PSA which is the ratio of free PSA to the total PSA level. While not absolute, generally the percentage of free PSA is lower in men who have prostate cancer than in men who do not. Some authors have suggested the free-to-total PSA ratio may be used as an additional screen to help prevent some men with false positive total PSA results needing a prostate biopsy.[8,10,11]
Evidence from a longitudinal PSA trial in men aged 55 to 69 indicate PSA screening may prevent approximately 1.3 deaths per 1000 men from prostate cancer over approximately 13 years.[2,12] PSA screening programs may also prevent approximately 3.1 cases of metastatic prostate cancer per 1000 men screened.[13] In the 16-year European Randomized Study of Screening for Prostate Cancer trial, no benefit from screening was found for men 70 to 74 years old.[14] Many clinical guidelines do not recommend PSA screening for prostate cancer in men 70 years and older.
False positive PSA tests are not uncommon. In one large study of over 60,000 subjects, 17.8% had one or more false positive PSA results, and 50% of those had a second false positive later on. However, men with false positives were more likely to be later diagnosed with prostate cancer than those with negative results (10% vs 2.6-2.7%). Most of the cancers found in subjects with earlier false positives were localized cancers but 6.3% were aggressive types. The authors were not sure if the higher rate of cancer found in men with false positive PSA tests was due to an actual increase in incidence in that group or just the result of more intense follow-up.[15]
Negative Effects of PSA Testing
A positive PSA test frequently leads to prostate biopsy to confirm whether or not there is cancer which may have some adverse effects.
In the 16-year European Randomized Study of Screening for Prostate Cancer trial, only 25% or about 5,000 of over 20,000 biopsies performed were positive for cancer after an elevated PSA.[14] The USPSTF guidelines cite literature estimates that 20% to 50% of prostate cancers are overdiagnosed.[2]
In one trial the following symptoms were reported 35 days after having a prostate biopsy. 44% of men reported pain and 7.3% rated it as a moderate or serious problem. 20% still had fever with 5.5% of the men reporting the fever as a moderate or serious problem. 66% had blood in the urine; 6% found this a moderate or serious problem. 37% had blood in the stool and 2% found this a moderate or serious problem. 90% had blood in the semen and 25% found this a moderate or serious problem.[16]
One large study found hospital admission rates after prostate biopsy increased from 1% in 1996 to 4.1% in 2005, mostly from infection complications. The 30-day mortality rate for prostate biopsy was .09%. Complications occurred mostly in older more unhealthy patients.[17] Another study found a mortality rate of 1.3% in the biopsy group vs 0.3 % in a control no biopsy group after 120 days. The mortality rate was 0.2% for men under 60 years of age and 2.5 % in men 76-80 years of age in that study.[18]
Temporary urinary retention may be another complication of prostate biopsy.
If radical prostatectomy or radiation therapy are performed as a result of a positive prostate biopsy, potential adverse effects may increase. About 20% of men who undergo radical prostatectomy develop long-term urinary incontinence, and about two- thirds will experience long-term erectile dysfunction. More than half of men who receive radiation therapy will experience long-term sexual erectile dysfunction and up 16% experience long-term bothersome bowel symptoms including bowel urgency and incontinence.[2]
How Accurate is a Standard Transrectal Biopsy?
In the standard transrectal systematic biopsy typically 12 or more core samples are taken from different areas of the prostate for analysis. Some authors recommend a higher number of core samples to try to improve sensitivity.
The false negative rate of transrectal biopsy can be as high as 30%.[19] Even 20 core sample biopsies were found to have close to a 10% false negative rate in one study.[19] In another study standard transrectal ultrasonic biopsy was only 48% sensitive for finding clinically significant prostate cancer.[20]
As a result of the false negative rate, many men will require multiple biopsies to confirm a diagnosis of prostate cancer.
Another biopsy method that has gained some popularity is the transperineal template biopsy. The samples are taken directly through the perineal skin into the prostate gland. A targeted template biopsy is used if the intention is to focus on one part of the prostate because previous assessments have identified the location of the significant disease. A saturation template biopsy is used if the intention is to assess the whole of the prostate, taking many tissue samples.[21] The main advantage of the transperineal route is a significant decrease in the post-biopsy infection rate compared to the transrectal route as the trocar is going through skin rather than through the rectal wall. The disadvantages are that as it is more painful, it is typically done under general anesthesia and it is a longer procedure than a transrectal biopsy.
A meta-analysis and systematic review found transrectal and transperineal biopsies were similar in their ability to diagnose prostate cancer. It was found that transperineal biopsy significantly decreased the risk of rectal bleeding and fever, while transrectal biopsy resulted in less pain. There was no significant difference in acute urinary retention and hematuria.[22] Another meta-analysis found a sepsis rate of 0.09 % to 0.13% after transperineal biopsy.[23] In one study of 245 transperineal biopsies there were zero cases of sepsis. The authors stated that in the literature, rates of sepsis after transperineal biopsy were 40 to 70 times lower than transrectal.[24]
MRI
MRI has improved the diagnosis of prostate cancer. Although not perfect, MRI may potentially be used after an abnormal PSA to determine the need for biopsy. It can also be used during a prostate biopsy to help localize the areas that need testing.
The most common test performed for cancer localization is the multiparametric MRI (MPMRI) where a standard MRI of the prostate is done followed by an additional MRI scan to examine other prostate tissue parameters, such as diffusion weighted imaging or dynamic contrast enhanced MRI. [25]
In the traditional transrectal ultrasound biopsy, the physician takes a number of core samples of the prostate. In an MRI/ultrasound fusion-guided transrectal prostate biopsy, during the biopsy procedure transrectal ultrasound is used to view to prostate, and a computer program fuses the previously done MRI and ultrasound images together for the clinician to view. This allows the clinician to more accurately get biopsy samples from any suspicious areas seen on the MRI images.[25]
How Accurate is MRI for Prostate Cancer?
Below are the findings of one systemic review of MPMRI for diagnosing clinically significant prostate cancer in men without a previous biopsy who had an elevated PSA.
Men without a previous biopsy and elevated PSA
Diagnostic Accuracy of MPMRI for clinically significant prostate cancer
Sensitivity | 87.8%-96% |
Specificity | 29.2% - 43.3% |
Positive Predictive Value | 45.9% to 60.2% |
Negative Predictive Value | 79.7% to 92% |
[26]
What these statistics indicate is that most men who have clinically significant prostate cancer will often be picked up by MPMRI. (87.8%-96%) However, due to the low specificity (29.2%-43.3%) there are many false positives, resulting in a low positive predictive value of 45.9%- 60.2% (Positive predictive value is the probability that a patient who gets an abnormal result truly has the disease.) Due to the high sensitivity, with fewer false negative results, a negative result has a 79.7-92% probability that it is a true negative and the person does not have the disease. (Negative predictive value)[26]
In another meta-analysis, the sensitivity of MPMRI for detecting any type of prostate cancer (not just clinically significant cancer) was 74%, or a false negative rate of 26%.[27]
Based on their data, the authors of one trial postulated that use of MPMRI as triage would decrease unnecessary biopsies by 27%, and result in a 5% decrease in clinically insignificant cancers being found and potentially treated.[20] Use of fusion MPMRI in transrectal biopsy procedures instead of standard transrectal ultrasonic biopsies would result in 18% more clinically significant cancers being found.[20]
An additional MRI targeting method is an in-bore prostate biopsy. The procedure is carried out within the MRI scanner, and areas of interest are selected and biopsied using guidance from serial scans during the procedure.[28] One study comparing fusion MPMRI versus in-bore MRI prostate biopsies found in-bore to be superior to fusion MRI in detection of cancer in targeted lesions but no difference was found in cancer detection in systematic untargeted sampling between the two methods.[29]
A Cochrane review of the literature compared MRI screening versus systematic transrectal prostate biopsy for evaluation of an elevated PSA test or an abnormal rectal exam. The authors concluded that both the MRI pathway and systematic prostate biopsy missed considerable numbers of grade 2 or higher prostate cancers, but that the MRI pathway performed better than systematic transrectal biopsy did. They further found that the MRI pathway missed more grade 1 prostate cancer than systematic biopsy did in men and the MRI pathway could potentially reduce the amount of overdiagnosis, and harms related to overtreatment. They concluded that MRI before any prostate biopsy and use of MRI as the replacement for systematic biopsy in certain specified circumstances, might provide the most favorable diagnostic strategy.[30]
Conclusion: MRI can be used as a tool to improve biopsy accuracy, but MRI is nowhere near 100% accurate for detecting or ruling out clinically significant prostate cancer by itself. The risks and benefits of following up and monitoring men with positive PSA results with only MPMRIs instead of performing a biopsy should be discussed with the patient.
Active Surveillance
Active monitoring or surveillance in selected cases of biopsy positive prostate cancer rather than going on to radiation therapy or radical prostatectomy has become a more popular option. In the US from 2005-2009 about 10% of men with low-risk prostate cancer received it. That had risen to 40.4% in 2010-2013.[2,32]
One study found that 6.0% of men in the active surveillance group developed metastatic cancer, compared with 2.7% in the radiation therapy group and 2.3% in the radical prostatectomy groups. During the 10-year study follow-up period, 54.8% of men in the active surveillance group required active treatment, while 44% did not.[2,32]
A large study of over 1,600 subjects over 15 years found no significant difference in the death rates between active monitoring, prostatectomy or radiation therapy. There was a higher rate of metastases in the active monitoring group than the other two treatments. ( 9.4% versus 4.7% and 5.0%) [32A]
The data from these trials suggests that active monitoring/surveillance requires frequent monitoring of patients choosing this option.
Recommendations
Men Over 70 Years of Age
The US Preventive Services Task Force (USPSTF) recommendation is to not screen any asymptomatic male over the age of 70. In one study the 10-year survival rate for localized prostate cancer was 99% regardless of whether the subjects received active monitoring, surgery or radiation therapy.[33] In men over 70 years of age, there is a lack of trial evidence of benefit, a low likelihood of benefit given the time frame to realize benefit, and increased risk of harm from false-positive results, biopsies, overdiagnosis and overtreatment of prostate cancer.[2]. However, the USPSTF did recognize that some clinicians and men over 70 may still want PSA testing, but recommended that the risks and benefits should be discussed.
Men Between 55 and 69 Years of Age
For men aged 55 to 69 years, the USPSTF recommendation is that the decision to have periodic PSA-based screening for prostate cancer should be an individual one and should include discussion of the potential benefits and harms of screening with their clinician. Screening offers a small potential benefit of reducing the chance of death and metastatic spread from prostate cancer in some men. However, many men will experience potential harm from screening, including false-positive results that require additional testing and possible prostate biopsy and treatment complications such as incontinence and erectile dysfunction.[2]
Special Considerations
Black men are more likely than white men to develop prostate cancer, have higher rates of aggressive cancer and are more than twice as likely to die from prostate cancer (44.1 vs 19.1 deaths per 100,000 men). Black men are also seven times more likely to have infectious complications after prostate biopsy than non-Black men.[2]
There are a number of studies that have demonstrated genetic links to prostate cancer in some families. Men who have one or more first-degree relative/s who have had a severe case of prostate cancer were 30% more likely to be diagnosed with prostate cancer than men without a family history.[2]
The USPSTF guidelines were unable to make specific recommendations about whether black men or men with first degree family members who had prostate cancer should be screened more liberally than the general population, and suggested more research is needed. However other guidelines do address that issue.[2] The American Cancer Society’s guidelines recommend Black men and first-degree relatives of prostate cancer patients have a discussion about screening at 45 years of age.[33] The American College of Physicians’ (ACP) guidelines suggest those who are at high risk such as Black men or have a strong family history may benefit from earlier screening beginning at age 45, while higher risk men (those with two or more first-degree relatives with prostate cancer before age 65) may benefit from being screened at age 40. The ACP guidelines also suggest that screening is not recommended in men who have a life expectancy of less than 10 to 15 years.[34] Similar 10 to 15-year life expectancy guidelines are also in the American Urological Association’s guidelines.[35]
The Canadian Task Force on Preventive Health Care has somewhat different guidelines, stating that PSA screening for asymptomatic patients of all ages is not recommended due to concerns of harms outweighing benefits. However, for high-risk patients or men that want screening there should be a discussion of the risks and benefits to facilitate informed decision making.[36]
Conclusion
The decision to screen asymptomatic individuals for prostate cancer is a complex issue. Due to false positive PSA tests, too much testing may result in iatrogenic harm in patients that have clinically insignificant prostate cancer or no cancer, and doing too little testing might cause some men with aggressive forms of prostate cancer to not be diagnosed in time for adequate treatment. Also problematic is that no one test or combination of tests has 100% sensitivity and specificity. Due to these issues, the most common recommendation is to use shared decision making between the patient and the clinician to determine an individual’s risk/benefit tolerance in choosing prostate cancer screening testing.
Due to the slow growing nature of most prostate cancers and autopsy evidence of incidental prostate cancer found in 36% to 51% of men in their 70s, the recommendation is not to do PSA screening in asymptomatic men over the age of 70.
In asymptomatic men 55 to 69 years of age, shared decision making is recommended before drawing a PSA to allow men to make an informed decision on how they want to proceed.
Asymptomatic Black men and men with close relatives who have had prostate cancer may benefit from screening at younger ages, and some clinical guidelines support this. These men should be informed of their higher risk for prostate cancer when discussing PSA testing. However, further research is needed regarding the best course of action in these high-risk groups.
Digital rectal exam may be helpful as a screen for prostate cancer if positive for a mass, but some guidelines recommend not performing it on asymptomatic patients due to a lack of evidence of benefits. There are however, other reasons to do a rectal exam in an annual physical, such as finding rectal carcinoma or occult bleeding from a cancer, diseases where the benefits of early discovery and treatment are clearer than with prostate cancer.
MRI fusion guided transrectal biopsies seem to improve accuracy over standard transrectal ultrasonic biopsy. MPMRI screening after a positive PSA has the potential to decrease unnecessary biopsies but this is countered but the fact that MPMRI will both under and over diagnose prostate cancer, and both clinicians and patients should be aware of this. Transperineal biopsies have been found to have much lower infection rates than transrectal biopsies, but the transperineal route typically requires general anesthesia.
Screening for prostate cancer with PSA testing is far from a perfect process given the high false positive rate. Follow-up testing and treatment may save lives, but also may cause iatrogenic harms if treating a cancer that may never have become symptomatic in that patient’s lifetime. MPMRI and fusion guided biopsies represent incremental advances over past methods but hopefully, in the future, further improvements in screening and testing modalities will allow better methods to diagnose and treat prostate cancer.
INDICATIONS FOR PROSTATE CANCER SCREENING
A urologist’s perspective By Arno Housman, MD
The controversy regarding whether or not to pursue prostate cancer screening is the direct consequence not of the prevalence, or lethal nature of the disease, but rather our current inability to accurately identify the natural history and aggressiveness of the tumor on an individualized basis.
The optimal strategy for management of prostate cancer remains a subject of ongoing debate. This is due to the heterogeneity of the disease, causing it to present and behave differently with each patient. Concern regarding overdiagnosis, and over treatment of men with low-risk tumors must be weighed against the consequences of underdiagnosis and under treatment of high-risk tumors. The controversy does not stop there. Once diagnosed, the urologist must decide whether it is appropriate to “actively observe” a patient or pursue active treatment, and even then, the optimal sequence of treatment remains a subject of continuing debate. This is no less true when contemplating a management strategy for patients found to have metastatic disease at the time of discovery.
So, returning to the controversy “to screen or not to screen”: the purpose of screening is to detect disease early enough to not only prevent avoidable mortality from metastatic disease but also morbidity. With the management of prostate cancer this goal includes finding the disease at a stage that allows either cure or at least conversion of the disease from a highly morbid process to a manageable “disease of chronic illness”. Screening with a combination of PSA blood testing and rectal examination has its benefits and drawbacks but appears to be exquisitely sensitive in detecting prostatic abnormalities but not very specific regarding prostate cancer. In some studies, rectal exam is reported to be nearly 30% sensitive overall for detecting prostate cancer and nearly 84% specific for ruling it out if the examination is normal.[5] The prostate exam is essentially free and without any appreciable morbidity. Once the screener has detected a prostatic abnormality it is the responsibility of the urologist to determine whether observation, further blood testing, imaging or biopsy is indicated. Hopefully as new diagnostic techniques and therapeutic nomograms evolve this decision-making process will be less controversial.
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References
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