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CURRENT Practice Guidelines in Primary Care 2019

Chapter 6: Genitourinary Disorders

BLADDER CANCER

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Population

–Asymptomatic persons.

Recommendation

AAFP 2011, USPSTF 2016

–Do not screen routinely for bladder cancer (CA) in adults.

Sources

Comments

Benefits and Harms
1. There is inadequate evidence to determine whether screening for bladder CA would have any impact on mortality. Based on fair evidence, screening for bladder CA would result in unnecessary diagnostic procedures and overdiagnosis (70% of bladder CA is in situ) with attendant morbidity. (NCI, 2017)
Clinical Awareness
1. Urinary biomarkers (nuclear matrix protein 22, tumor-associated antigen p300, presence of DNA ploidy) do not have significant sensitivity or specificity to be utilized in clinical practice. Microscopic hematuria leads to a diagnosis of bladder CA in only 5% of patients.
2. Seventy-nine thousand cases of bladder CA are expected in 2017 in the United States, with the majority being noninvasive (70%), but still 16,900 Americans are expected to die of bladder CA in 2017. (Ann Inter Med. 2010;153:461) (Eur Urol. 2013;63:4)
3. A high index of suspicion should be maintained in anyone with a history of smoking (4- to 7-fold increased risk^a), an exposure to industrial toxins (aromatic amines, benzene), therapeutic pelvic radiation, cyclophosphamide chemotherapy, a history of Schistosoma haematobium cystitis, hereditary nonpolyposis colon CA (Lynch syndrome), and history of transitional cell carcinoma of ureter (50% risk of subsequent bladder CA). Large screening studies in these high-risk populations have not been performed.
4. Voided urine cytology with sensitivity of 40% but only 10% positive predictive value, urinary biomarkers (nuclear matrix protein 22, telomerase) with suboptimal sensitivity and specificity. Screening for microscopic hematuria has <10% positive predictive value.

CERVICAL CANCER

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Population

–Women age <21 y.

Recommendation

ACS 2017, USPSTF 2015, ACOG 2016

–Do not screen for cervical cancer.

Population

–Women age 21–29 y.

Recommendations

ACS 2017, USPSTF 2018, ACOG 2016

–Cytology alone (PAP smear) every 3 y until age 30 y.
–Do not use human papillomavirus (HPV) DNA testing in this age group—the majority of young patients will clear the infection.

Population

–Women age 30–65 y at average risk.

Recommendations

ACS 2017, ACOG 2016

–Screen with HPV and cytology “co-testing” every 5 y (preferred) or cytology alone every 3 y (acceptable).
–If HPV positive/cytology negative—either follow up in 12 mo with co-testing or test for HPV 16 or 18 genotypes and proceed to colposcopy if positive.
–Continue to screen more frequently if high-risk factors are present.^b,c,d

USPSTF 2018

–Screen with cytology every 3 y.
–If a woman wants to extend her screening interval, perform co-testing (cytology/HPV testing) every 5 y.
–Primary hrHPV testing every 5 y is a valid alternative to co-testing or cytology alone.

Population

–Age >65 y or after hysterectomy.

Recommendation

ACS 2017, ACOG 2016, USPSTF 2015

–Do not screen if the patient has had adequate prior screening with negative results (no history of CIN 2, CIN 3, or adenocarcinoma in situ in the past 20 y or in the history of cervical cancer ever).

Sources

–http://www.cancer.org
–http://www.survivorshipguidelines.org
–CA Cancer J Clin. 2012;62:147-172.
–N Engl Med. 2013;369:2324.
–https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/cervical-cancer-screening2
–Ann Intern Med. 2012;156:880.

Comments

Ten percent of women age 30–34 y will have normal cytology but a positive HPV test and will need more frequent testing. In women 60–65 y only 2.5% will have negative cytology but positive HPV testing.
Clinical concerns: It is estimated that 12,820 cases of invasive cervical CA will be diagnosed in the United States in 2017, and 4210 women will die of this disease (American Cancer Society: facts and figures 2017).
1. Cervical CA is causally related to infection with HPV (>70% associated with either HPV-18 or HPV-16 genotype).
2. Immunocompromised women (organ transplantation, chemotherapy, chronic steroid therapy, or human immunodeficiency virus [HIV]) should be tested twice during the first year after initiating screening and annually thereafter. (CA Cancer J Clin. 2011;61:8) (Ann Intern Med. 2011;155:698)
3. Women with a history of cervical CA or in utero exposure to diethylstilbestrol (DES) should indefinitely continue average-risk protocol for women age <30 y.
4. HPV vaccination of young women is now recommended by ACIP, UK-NHS, and others. Cervical CA screening recommendations have not changed for women receiving the vaccine because the vaccine covers only 70% of HPV serotypes that cause cervical CA. (MMWR. 2007;56(RR-2):1-24) (CA cancer J Clin. 2014;64:30) (N Engl J Med. 2015;372:711)
5. Long-term use of oral contraceptives may increase risk of cervical CA in women who test positive for cervical HPV DNA. (Lancet. 2002;359:1085)
6. Smoking increases risk of cervical CA 4-fold. (Am J Epidemiol. 1990;131:945)
7. A vaccine against HPV-16 and HPV-18 significantly reduces the risk of acquiring transient and persistent infection. (N Engl J Med. 2002;347:1645) (Obstet Gynecol. 2006;107(1):4)
8. New dosing schedule for HPV vaccinations: 2 doses for girls and boys who initiate vaccination series at age 9–14; 3 doses are recommended for ages 15–26 y and for immunosuppressed persons. (CA Cancer J Clin. 2017;67:100)
9. Benefits: Based on solid evidence, regular screening of appropriate women with the Pap test reduces mortality from cervical CA. Screening is effective when started at age 21. Harms: Based on solid evidence, regular screening with the Pap test leads to additional diagnostic procedures and treatment for low-grade squamous intraepithelial lesions (LSILs), with uncertain long-term consequences on fertility and pregnancy. Harms are greatest for younger women, who have a higher prevalence of LSILs. LSILs often regress without treatment. False positives in postmenopausal women are a result of mucosal atrophy. (NCI, 2008)
10. A study with 43,000 women ages 29–61 with both HPV DNA and cervical cytology co-testing every 5 y found that the cumulative incidence of cervical cancer in women negative for both tests at baseline was 0.01% at 9 y and 0.07% after 14 y. (BMJ. 2016;355:4924)
11. There is basically now no significant difference in guidelines for screening for cervical CA in average-risk women among ACOG, ACS, USPSTF.
12. The risk of developing invasive cervical CA is 3–10 times greater in women who have not been screened. (CA Cancer J Clin. 2017;67:106)

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CERVICAL CANCER SCREENING GUIDELINES FOR AVERAGE-RISK WOMEN^a

American Cancer Society (ACS), American Society for Colposcopy and Cervical Pathology (ASCCP), and American Society for Clinical Pathology (ASCP) 2012

US Preventive Services Task Force (USPSTF) 2018

American College of Obstetricians and Gynecologists (ACOG) 2016

Society of Gynecologic Oncology (SGO) and the American Society for Colposcopy and Cervical Pathology (ASCCP): Interim clinical guidance for primary hrHPV testing 2015

When to start screening^b

Age 21. Women aged <21 y should not be screened regardless of the age of sexual initiation or other risk factors.

Age 21 (A recommendation). Recommend against screening women aged <21 y (D recommendation).

Age 21 regardless of the age of onset of sexual activity. Women aged <21 y should not be screened regardless of age at sexual initiation and other behavior-related risk factors (Level A evidence).

Refer to major guidelines.

Statement about annual screening

Women of any age should not be screened annually by any screening method.

Individuals and clinicians can use the annual Pap test screening visit as an opportunity to discuss other health problems and preventive measures. Individuals, clinicians, and health systems should seek effective ways to facilitate the receipt of recommended preventive services at intervals that are beneficial to the patient. Efforts also should be made to ensure that individuals are able to seek care for additional health concerns as they present.

In women aged 30–65 y annual cervical cancer screening should not be performed. (Level A evidence) Patients should be counseled that annual well-woman visits are recommended even if cervical cancer screening is not performed at each visit.

Not addressed.

Screening method and intervals

Cytology (conventional or liquid-based)^c

21–29 y of age

Every 3 y.^d

Every 3 y (A recommendation).

Every 3 y (Level A evidence).

Not addressed.

30–65 y of age

Every 3 y.^d

Every 3 y (A recommendation).

Every 3 y (Level A evidence).

Not addressed.

HPV co-test (cytology + HPV test administered together)

21–29 y of age

HPV co-testing should not be used for women aged <30 y.

Recommend against HPV co-testing in women aged <30 y (D recommendation).

HPV co-testing^e should not be performed in women aged <30 y (Level A evidence).

Not addressed.

30–65 y of age

Every 5 y; this is the preferred method.

For women who want to extend their screening interval, HPV co-testing every 5 y is an option (A recommendation).

Every 5 y; this is the preferred method (Level A evidence).

Not addressed.

Primary hrHPV testing^f (as an alternative to co-testing or cytology alone)^g

For women aged 30–65 y, screening by HPV testing alone is not recommended in most clinical settings.^h

Every 5 y for women 30–65 y of age (A recommendation).

Alternative screening every 3 y for women ≥25 y as per SGO and ASCCP interim guidance (Level B evidence).

Every 3 y. Recommend against primary hrHPV screening in women aged <25 y of age.ⁱ

Aged >65 y with adequate negative prior screening^* and no history of CIN2 or higher within the last 20 y.^j

When to stop screening

*Adequate negative prior screening results are defined as 3 consecutive negative cytology results or 2 consecutive negative co-test results within the previous 10 y, with the most recent test performed within the past 5 y.

Aged >65 y with adequate screening history^* and are not otherwise at high risk for cervical cancer^j (D recommendation).

Aged >65 y with adequate negative prior screening^* results and no history of CIN 2 or higher^j (Level A evidence).

Not addressed.

When to screen after age 65 y

Aged >65 y with a history of CIN2 CIN2, CIN3, or adenocarcinoma in situ, routine screening^l should continue for at least 20 y.

Women aged >65 y who have never been screened, do not meet the criteria for adequate prior screening, or for whom the adequacy of prior screening cannot be accurately accessed or documented.^k Routine screening^l should continue for at least 20 y after spontaneous regression or appropriate management of a high-grade precancerous lesion, even if this extends screening past age 65 y. Certain considerations may support screening in women aged >65 y who are otherwise considered high risk (such as women with a high-grade precancerous lesion or cervical cancer, women with in utero exposure to diethylstilbestrol, or women who are immunocompromised).

Women aged >65 y with a history of CIN2, CIN3, or AIS should continue routine age-based screening^l for at least 20 y (Level B evidence).

Not addressed.

Screening post-hysterectomy

Women who have had a total hysterectomy (removal of the uterus and cervix) should stop screening.^m Women who have had a supra-cervical hysterectomy (cervix intact) should continue screening according to guidelines.

Recommend against screening in women who have had a hysterectomy (removal of the cervix)ⁿ (D recommendation).

Women who have had a hysterectomy (removal of the cervix) should stop screening and not restart for any reasonⁿ^,^o (Level A evidence).

Not addressed.

The need for a bimanual pelvic exam

Not addressed in 2012 guidelines but was addressed in 2002 ACS guidelines.^p

Addressed in USPSTF ovarian cancer screening recommendations (draft).^q

Addressed in 2012 well-woman visit recommendations.^r Aged <21 y, no evidence supports the routine internal examination of the healthy, asymptomatic patient. An “external-only” genital examination is acceptable. Aged ≥21 y, no evidence supports or refutes the annual pelvic examination or speculum and bimanual examination. The decision whether or not to perform a complete pelvic examination should be a shared decision after a discussion between the patient and her health care provider. Annual examination of the external genitalia should continue.^s

Not addressed.

Screening among those immunized with HPV vaccine

Women at any age with a history of HPV vaccination should be screened according to the age specific recommendations for the general population.

The possibility that vaccination might reduce the need for screening with cytology alone or in combination with HPV testing is not established. Given these uncertainties, women who have been vaccinated should continue to be screened.

Women who have received the HPV vaccine should be screened according to the same guidelines as women who have not been vaccinated (Level C evidence).

Not addressed.

HPV = human papillomavirus; CIN = cervical intraepithelial neoplasia; AIS=adenocarcinoma in situ; hrHPV = high-risk HPV.

^aThese recommendations do not address special, high-risk populations who may need more intensive or alternative screening. These special populations include women with a history of CIN2, CIN3, or cervical cancer, women who were exposed in utero to diethylstilbestrol, women who are infected with HIV, or women who are immunocompromised (such as those who have received solid organ transplants).

^bSince cervical cancer is believed to be caused by sexually transmissible human papillomavirus infections, women who have not had sexual exposures (eg, virgins) are likely at low risk. Women aged >21 y who have not engaged in sexual intercourse may not need a Pap test depending on circumstances. The decision should be made at the discretion of the women and her physician. Women who have had sex with women are still at risk of cervical cancer. Ten to fifteen percent of women aged 21–24 y in the United States report no vaginal intercourse (Saraiya M, Martinez G, Glaser K, et al. Obstet Gynecol. 2009;114(6):1213–1219. doi: 10.1097/AOG.0b013e3181be3db4.). Providers should also be aware of instances of non consensual sex among their patients.

^cConventional cytology and liquid-based cytology are equivalent regarding screening guidelines, and no distinction should be made by test when recommending next screening.

^dThere is insufficient evidence to support longer intervals in women aged 30–65 y, even with a screening history of negative cytology results.

^eAll ACOG references to HPV testing are for high-risk HPV testing only. Tests for low-risk HPV should not be performed.

^fPrimary hrHPV testing is defined as a stand-alone test for cervical cancer screening without concomitant cytology testing. It may be followed by other tests (like a Pap) for triage. This test specifically identifies HPV 16 and HPV 18, while concurrently detecting 12 other types of high-risk HPVs.

^gBecause of equivalent or superior effectiveness, primary hrHPV screening can be considered as an alternative to current US cytology-based cervical cancer screening methods. Cytology alone and cotesting remain the screening options specifically recommended in major guidelines.

^hMore experience and data analysis pertaining to the primary hrHPV screening will permit a more formal ACS evaluation.

ⁱPrimary hrHPV screening should begin 3 y after the last negative cytology and should not be performed only 1 or 2 y after a negative cytology result at 23–24 y of age.

^jOnce screening is discontinued it should not resume for any reason, even if a woman reports having a new sexual partner.

^kWomen older than age 65 y who have never been screened, women with limited access to care, minority women, and women from countries where screening is not available may be less likely to meet the criteria for adequate prior screening.

^lRoutine screening is defined as screening every 5 y using cotesting (preferred) or every 3 y using cytology alone (acceptable).

^mUnless the hysterectomy was done as a treatment for cervical pre-cancer or cancer.

ⁿAnd no history of CIN2 or higher in the past 20 y.

^oWomen should continue to be screened if they have had a total hysterectomy and have a history of CIN 2 or higher in the past 20 y or cervical cancer ever. Continued screening for 20 y is recommended in women who still have a cervix and a history of CIN 2 or higher. Therefore, screening with cytology alone every 3 y for 20 y after the initial post-treatment surveillance for women with a hysterectomy is reasonable (Level B evidence).

^p2002 guidelines statement: The ACS and others should educate women, particularly teens and young women, that a pelvic exam does not equate to a cytology test and that women who may not need a cytology test still need regular health care visits including gynecologic care. Women should discuss the need for pelvic exams with their providers. Saslow D, Runowicz CD, Solomon D, et al. American Cancer Society Guideline for the Early Detection of Cervical Neoplasia and Cancer. CA Cancer J Clin 2002;52:342–362.

^qThe bimanual pelvic examination is usually conducted annually in part to screen for ovarian cancer, although its effectiveness and harms are not well known and were not a focus of this review. No randomized trial has assessed the role of the bimanual pelvic examination for cancer screening. In the PLCO Trial, bimanual examination was discontinued as a screening strategy in the intervention arm because no cases of ovarian cancer were detected solely by this method and a high proportion of women underwent bimanual examination with ovarian palpation in the usual care arm.

^rACOG Committee Opinion No. 534: Well-Woman Visit. Committee on Gynecologic Practice. Obstet Gynecol. 2012;120(2)1:421–24. doi: 10.1097/AOG.0b013e3182680517.

^sFor women aged ≥21 y, annual pelvic examination is a routine part of preventive care even if they do not need cervical cytology screening, but also lacks data to support a specific time frame or frequency of such examinations. The decision to receive an internal examination can be left to the patient if she is asymptomatic and has undergone a total hysterectomy and bilateral salpingo-oophorectomy for benign indications, and is of average risk.

ENDOMETRIAL CANCER

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Population

–Postmenopausal women.

Recommendations

ACS 2008

–Do not screen routinely.
–Inform women about risks and symptoms of endometrial CA and strongly encourage them to report any unexpected bleeding or spotting. This is especially important for women with an increased risk of endometrial CA (history of unopposed estrogen therapy, tamoxifen therapy, late menopause, nulliparity, infertility or failure to ovulate, obesity, diabetes, or hypertension).

Source

–http://www.cancer.org

Comments

Benefits: There is inadequate evidence that screening with endometrial sampling or transvaginal ultrasound (TVU) decreases mortality. Harms: Based on solid evidence, screening with TVU will result in unnecessary additional exams because of low specificity. Based on solid evidence, endometrial biopsy may result in discomfort, bleeding, infection, and, rarely, uterine perforation. (NCI, 2008)
Presence of atypical glandular cells on Pap test from postmenopausal (age >40 y) women not taking exogenous hormones is abnormal and requires further evaluation (TVU and endometrial biopsy). Pap test is not sensitive for endometrial screening.
Endometrial thickness of <4 mm on TVU is associated with low risk of endometrial CA. (Am J Obstet Gynecol. 2001;184:70)
Most cases of endometrial CA are diagnosed as a result of symptoms reported by patients (uterine bleeding), and a high proportion of these cases are diagnosed at an early stage and have high rates of cure. Type II endometrial CA accounts for 15% of patients. Histology is serous or clear cell. Five year survival is 55% vs. 85% for endometrial Type I cancer. (NCI, 2008) (Lancet. 2016;387:1094)
Tamoxifen use for 5 y raises the risk of endometrial CA 2- to 3-fold, but CAs are low stage, low grade, with high cure rates. (J Natl Cancer Inst. 1998;90:1371)
In 2016, there were 60,050 new cases of endometrial cancer with 10,170 deaths. The mean age at diagnosis is 60 y.

Population

–Women at highest risk for endometrial CA^a (patients with known or high suspicion for HNPCC mutation carrier).

Recommendations

ACS 2016

–Annual screening beginning at age 35 y with endometrial biopsy.
–International guidelines advise transvaginal ultrasound and annual endometrial biopsy beginning at 25 y old.

Sources

–CA Cancer J Clin. 2005;55:31.
–JAMA. 1997;277:915.
–http://www.cancer.org

Comments

High-risk women—Lynch syndrome—lifetime risk 60%
1. Variable screening with ultrasound among women (age 25–65 y; n = 292) at high risk for HNPCC mutation detected no CAs from ultrasound. Two endometrial cancers occurred in the cohort that presented with symptoms. (Cancer. 2002;94:1708) (Gynecol Oncol. 2007;107:159)
2. The death rate from sporadic endometrial cancer and Lynch syndrome related uterine cancer is the same.
3. The Women’s Health Initiative (WHI) demonstrated that combined estrogen and progestin did not increase the risk of endometrial CA but did increase the rate of endometrial biopsies and ultrasound exams prompted by abnormal uterine bleeding. (JAMA. 2003;290(13):1739-1748)

OVARIAN CANCER

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Population

–Asymptomatic women at average risk.^a

Recommendations

USPSTF 2012

–Do not screen routinely.
–Beware of symptoms of ovarian CA that can be present in early-stage disease (abdominal, pelvic, and back pain; bloating and change in bowel habits; urinary symptoms). (Ann Intern Med. 2012;157:900-904) (J Clin Oncol. 2005;23:7919) (Ann Intern Med. 2012;156:182)

Sources

Population

–Women whose family history is associated with an increased risk for deleterious mutations in BRCA1 or 2 genes.^b

Recommendations

USPSTF 2013, NCCN 2017, ACOG 2017

–Refer for genetic counseling and evaluation for BRCA testing. Do not routinely screen.
–Screening with CA-125, transvaginal ultrasound, and pelvic exam can be considered, but have not been shown to improve survival rate.
–Test for BRCA1 and 2 mutations in any woman with ovarian cancer at any age.

Sources

–NCCN guideline version 2;2017. https://www.nccn.org
–Obstet Gynecol. 2017;130:e110-126.
–http://www.ahrq.gov/clinic/uspstf/uspsbrgen.htm

Population

–High-risk patients with BRCA1 or 2 mutations or strong family history of ovarian CA.

Recommendations

ACOG 2009, NCCN 2011

–Screen with CA-125 and TVU at age 30–35 y or 5–10 y earlier than earliest onset of ovarian CA in family members.
–Risk-reducing salpingo-oophorectomy should be strongly considered. (JAMA. 2010;304:967)

Source

–http://www.ahrq.gov/clinic/uspstf/uspsbrgen.htm

Comments

Risk factors: age >60 y; low parity; personal history of endometrial, colon, or breast CA; family history of ovarian CA; and hereditary breast/ovarian CA syndrome. Use of oral contraceptives for 5 y decreases the risk of ovarian CA by 50%. (JAMA. 2004;291:2705)
Benefit: There is inadequate evidence to determine whether routine screening for ovarian CA with serum markers such as CA-125 levels, TVU, or pelvic examinations would result in a decrease in mortality from ovarian CA. Harm: Problems have been lack of specificity (positive predictive value) and need for invasive procedures to make a diagnosis. Based on solid evidence, routine screening for ovarian CA would result in many diagnostic laparoscopies and laparotomies for each ovarian CA found. (NCI, 2008) (JAMA. 2011;305:2295)
Additionally, cancers found by screening have not consistently been found to be lower stage. (Lancet Oncol. 2009;10:327)
Preliminary results from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial: At the time of baseline examination, positive predictive value for invasive cancer was 3.7% for abnormal CA-125 levels, 1% for abnormal TVU results, and 23.5% if both tests showed abnormal results. (Am J Obstet Gynecol. 2005;193:1630)
Large United Kingdom trial assessing multimodal screening strategy (annual CA-125, risk of ovarian CA algorithm [ROLA], transvaginal ultrasound) vs. usual care: 202,639 women recruited (age 50–74) found nonsignificant mortality reduction up to 14 y F/U. (J Natl Compr Cancer Netw. 2016;14:1143) (Lancet. 2016;387:945)

PELVIC EXAMINATIONS

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Population

–Asymptomatic, nonpregnant women.

Recommendation

AAFP 2017, ACP 2014

–Do not perform routine screening pelvic examinations.

Sources

–AAFP. Clinical Recommendation: Screening Pelvic Exam. 2017.
–Ann Intern Med. 2014;161(1):67-72.

Recommendation

USPSTF 2017

–Insufficient evidence to recommend for or against screening pelvic examinations.

Source

–JAMA. 2017;317(9):947-953.

Recommendation

ACOG 2012

–Screen all women age 21+ with annual pelvic exam.

Source

–Obstet Gynecol. 2012;120:421-424.

Comments

Pelvic examination remains a necessary component of evaluation for many complaints.
While tradition and patient or physician experience may support an annual exam, outcome data does not (nor does the data clearly refute the exam).
Potential harms associated with screening include overdiagnosis, fear/anxiety/embarrassment, discomfort, additional diagnostic procedures.

PROSTATE CANCER

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Population

–Asymptomatic men.

Recommendations

ACS 2010, ACP 2013

–For men age 50 y and older, discuss annual prostate-specific antigen (PSA) and digital rectal exam (DRE) if ≥10-y life expectancy.^b
–Discuss risks and benefits of screening strategy to enable an informed decision.

USPSTF 2017

–Do not screen men younger than 55 y or older than 70 y.
–For men age 55–69 y, discuss potential benefits and harms of PSA screening (false-positive results) overdiagnosis and overtreatment and treatment complications vs. small potential benefit of reducing the chance of dying of prostate cancer. Individualize decision making so that each man can understand the potential benefits and harms of screening and make his decision.
–In high-risk patients (African-Americans, first-degree family members with prostate cancer and BRCA 1 and 2), help the patient weigh benefits and risks of screening.

EAU 2010

–There is a lack of evidence to support or disregard widely adopted, population-based screening programs for early detection of prostate CA.

NCCN 2016

–Employ informed decision-making.
–Obtain PSA testing in healthy men age 45–75 y.
- PSA <1 ng/mL—DRE normal—repeat testing @ 2–4 y intervals.
- PSA 1–3 ng/mL—DRE normal—repeat testing @ 1–2 y intervals.
- PSA >3 ng/mL or suspicious DRE—consider biopsy and work-up for benign disease. (J Natl Compr Canc Netw. 2015;13:570) (Mayo Clin Proc. 2016;91:17)
–After age 70 PSA testing should be individualized and indications for biopsy carefully evaluated.
–Refer patients for prostate biopsy if serum PSA rises >0.9 ng/mL in 1 y.

Sources

–http://www.ahrq.gov/clinic/uspstf/uspsprca.htm
–Ann Intern Med. 2012;157:120-134.
–Ann Intern Med. 2011;155:762-771.
–USPSTF. 2018.
–JAMA. 2018;319(18):1901-1913.
–Ann Intern Med. 2013;159:761-769.
–Ann Intern Med. 2013;158:145-153.
–www.uroweb.org
–www.cancerscreening.nhs.uk
–NCCN Guidelines. 2016.
–http://www.cancer.org

Comments

Prevalence: there are 220,800 new cases of prostate cancer and 27,500 deaths expected in 2017.
There is good evidence that PSA can detect early-stage prostate CA (2-fold increase in organ-confined disease at presentation with PSA screening), but mixed and inconclusive evidence that early detection improves health outcomes or mortality. Two long-awaited studies add to the confusion. A US study of 76,000 men showed increased prostate CA in screened group, but no reduction in risk of death from prostate CA. A European study of 80,000 men showed a decreased rate of death from prostate CA by 20% but significant overdiagnosis (there was no difference in overall death rate). To prevent 1 death from prostate CA, 1410 men needed to be screened, and 48 cases of prostate CA were found. Patients older than age 70 y had an increased death rate in the screened group. (N Engl J Med. 2009;360:1310,1320) (N Engl J Med. 2012;366:981, 1047) These 2 very large studies set the framework for new PC guidelines. The US study (prostate, lung, colorectal, and ovarian cancer screening trial) showed no evidence for overall survival benefit from PSA screening and postulated that many patients with low-grade cancers were treated aggressively, leading to morbidity and mortality. Subsequent evaluation found that approximately 90% of patients in the control arm had undergone PSA testing during the course of the trial. This fact makes the trial result uninterpretable. The European study found that PSA screening did reduce prostate-specific mortality by 20%. In this trial 781 men needed to be invited to screening to prevent 1 death. What should be the response to this new data? First we can improve survival by recognizing low-risk patients to be followed by active surveillance and not exposed to treatment until evidence of disease progression. Recognized high-risk patients (African-Americans and men with first-degree relatives with prostate cancer) should be screened early and frequently. Average-risk men can be screened by PSA twice between the ages of 45 and 55 and if the PSA is 0.70 ng/mL their risk of lethal prostate cancer is quite low. Guideline groups are presently working on new guidelines for PC screening to minimize overtreatment of this disease but at the same time screening a higher risk population for aggressive prostate cancer at a stage that can be treated with conservative intent. (N Engl J Med. 2017;376:1285) (J Clin Oncol. 2016;34:2705-2711, 3481-3491, 3499-3501)
Benefit: Insufficient evidence to establish whether a decrease in mortality from prostate CA occurs with screening by DRE or serum PSA. Harm: Based on solid evidence, screening with PSA and/or DRE detects some prostate CAs that would never have caused important clinical problems. Based on solid evidence, current prostate CA treatments result in permanent side effects in many men, including erectile dysfunction and urinary incontinence. (NCI, 2008)
Men with localized, low-grade prostate CAs (Gleason score 2–4) have a minimal risk of dying from prostate CA during 20 y of follow-up (6 deaths per 1000 person-years) (JAMA. 2005;293:2095) (N Engl J Med. 2014;370:932)
Many physicians continue to screen African-American men and men with a strong FH of prostate cancer despite the guidelines. (J Urol. 2002;168:483) (J Natl Cancer Inst. 2000;92:2009) (JAMA. 2014; 311:1143). African-American men have double risk of prostate cancer and a >2-fold risk of prostate cancer–specific death. These patients and those with first-degree relatives <65 y with prostate cancer are at high enough risk to justify PSA screening until a definitive study of this population is available. (JAMA. 2014;311:1143)
Increase in prostate cancer distant metastases at diagnosis in the United States over the last 3 y. (JAMA Oncol. 2016;2:1657)
Radical prostatectomy (vs. watchful waiting) reduces disease-specific and overall mortality in patients with early stage prostate CA. (N Engl J Med. 2011;364:1708) This benefit was seen only in men age >65 y. Active surveillance for low-risk patients is safe and increasingly used as an alternative to radical prostatectomy. (J Clin Oncol. 2010;28:126) (Ann Intern Med. 2012;156:582) A gene signature profile reflecting virulence and treatment responsiveness in prostate CA is now available. (J Clin Oncol. 2008;26:3930) (J Natl Compr NNetr. 2016;14:659)
PSA velocity (>0.5–0.75 ng/y rise) is predictive for the presence of prostate CA, especially with a PSA of 4–10. (Eur Urol. 2009;56:573)
Multi-parametric MRI scanning is emerging as a tool for more accurate detection of early prostate cancer as well as distinguishing indolent from high-grade cancers. (J Urol. 2011;185:815) (Nat Rev Clin Oncol. 2014;11:346)
PSA screening is confounded by the morbidity and mortality associated with the treatment of prostate cancer. Molecular profiling that can stratify patients into high-risk and low-risk groups is a critical need for individualized adaptive therapies, which could minimize toxicity and maximize benefit from there in many patients (oncotype, Decipher, and Polaris are now available to look at molecular profiling).
The NCCN recommendation aims to strike a balance between testing too seldom and testing too often to “maximize benefit and minimize harm.”

TESTICULAR CANCER

Listen

Population

–Asymptomatic adolescent and adult males.^a

Recommendations

AAFP 2008, USPSTF 2011

–Recommend against routine screening. Be aware of risk factors for testicular CA—previous testis CA (2%–3% risk of second cancer), cryptorchid testis, family history of testis CA, HIV (increased risk of seminoma), and Klinefelter syndrome.
–There is a 3- to 5-fold increase in testis cancer in white men vs. other ethnicity. (N Engl J Med. 2014;371:2005) (N Engl J Med. 2007;356:1835)

Sources

Population

–Asymptomatic men.

Recommendation

ACS 2004

–Testicular exam by physician as part of routine cancer-related checkup. (Ann Int Med. 2011;154:483) If there is any concern on exam, an ultrasound of the testis will be reliable in discovery of malignancy as small as 1–2 mm in size but benign lesions are also found by ultrasound in this population. (J Urol. 2003;170:1783)

Source

–http://www.cancer.org

Population

–High-risk males.^a

Recommendation

EAU 2008

–Self-physical exam is advisable.

Source

–www.uroweb.org

Comments

Benefits and Harms:
1. Benefits: Based on fair evidence, screening would not result in appreciable decrease in mortality, in part because therapy at each stage is so effective.
2. Harms: Based on fair evidence, screening would result in unnecessary diagnostic procedures and occasional removal of a noncancerous testis. (NCI, 2011)
3. In 2016 approximately 8850 men in the United States were diagnosed with testicular cancer but only 400 men died of this disease. Worldwide there are approximately 72,000 cases and 9000 deaths annually. (CA Caner J Clin. 2017;67:7)

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