National Comprehensive Cancer Network Guidelines Summary

For Physicians, Medical Professionals, Educators

Baseline evaluation:

History and physical (H&P) including: Family history, Medications (note: can impact PSA levels), History of prostate disease and screening (including prior PSA and/or isoforms, exams, and biopsies), Race.

Risk Assessment

Start risk and benefit discussion about offering prostate screening: Baseline PSA^a; and Consider Baseline digital rectal examination (DRE)^a

Age 45-75 (Unanimous consensus based on the current evidence)

PSA < 1^b (and normal DRE, if done): repeat screening every 2-4 years

PSA 1-3^c (and normal DRE, if done) – PSA screening 1 to 2 years

PSA >3^d: repeat PSA, DRE, and workup for benign disease. Proceed with: Biopsy, or repeat PSA^e, or Percent free PSA, 4KScore, or prostate health index (PHI)^e

B) Age > 75, in select patients^b (Category 2B consensus: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate)

CUT OFF FOR BIOPSY PER NCCN –

PSA > 3 FOR MEN AGED 45-75

PSA > 4 FOR MEN OLDER THAN 70^b

Comments:

^a The best evidence supports the use of serum PSA for the early detection of prostate cancer. DRE should not be used as a stand-alone test, but should be performed in those with an elevated serum PSA. DRE should be considered as a baseline test in all patients as it may identify high-risk cancers associated with “normal” serum PSA values.

^bTesting above the age of 75 years of age should be done with caution and only in very healthy men with little or no comorbidity as a large proportion may harbor cancer that would be unlikely to affect their life expectancy, and screening in this population would substantially increase rates of over-detection. However, a clinically significant number of men in this age group may present with high-risk cancers that pose a significant risk if left undetected until signs or symptoms develop. One could consider increasing the PSA threshold for biopsy in this group (i.e., >4 ng/mL). Very few men above the age of 75 years benefit from PSA testing.

^cThe reported median PSA values for men aged 40-49 y range from 0.5-0.7 ng/mL, and the 75th percentile values range from 0.7-0.9 ng/mL.Therefore, the PSA value of 1.0 ng/mL selects for the upper range of PSA values. Men who have a PSA above the median for their age group are at a higher risk for prostate cancer and for the aggressive form of the disease. The higher above the median, the greater the risk. Men at age 60 years with a serum PSA <1.0 ng/mL have a very low risk of metastases or death due to prostate cancer. Similarly, if PSA <3 in men aged 75 years or older is associated with low risk of death due to prostate cancer.

^dThe level of PSA correlates with the risk of prostate cancer. The Prostate Cancer Prevention Trial (PCPT) demonstrated that 15% of men with PSA ≤ 4 and normal DRE had prostate cancer diagnosed on end-of-study biopsies. About 30% to 35% of men with PSA ranging from 4 to 10 will be found to have prostate cancer. About 67% of men with PSA >10 will be found to have prostate cancer.

^eBiomarkers that may improve specificity of prostate cancer detection are not recommended as firstline screening tests. However, there may be some patients who meet either PSA, or DRE standards for biopsy, but for whom the patient or the physician may wish to further define the probability of high-grade prostate cancer. A percent free PSA of <10%, PHI >35, or 4KScore (which provide an estimate of the probability of prostate cancer) are potentially informative in patients who have never had biopsies or after a negative biopsy; a PCa3 score >35 is potentially informative after biopsy.