What to do with a patient with a Prostate-Specific Antigen (PSA) level of 5.79 who is already on tamsulosin (flomax)?

From the Guidelines

For a patient with a PSA level of 5.79 who is already on tamsulosin, the recommended approach is to refer them to a urologist for further evaluation, as this elevated PSA warrants additional assessment to rule out prostate cancer, considering that approximately 30% to 35% of men with serum PSAs in the 4 to 10 ng/mL range will be found to have cancer 1.

Key Considerations

• The patient's elevated PSA level of 5.79 ng/mL is above the typical normal range of 0-4 ng/mL, which necessitates further evaluation.
• Tamsulosin, an alpha-blocker used for benign prostatic hyperplasia (BPH), does not affect PSA levels, so the elevated PSA is not a result of the medication.
• The urologist will likely perform a digital rectal examination (DRE) and may recommend a prostate biopsy to rule out prostate cancer.
• The patient should be informed that tamsulosin treats urinary symptoms but does not address the elevated PSA.
• It is essential to note that an elevated PSA does not necessarily indicate cancer, as it can also result from BPH, prostatitis, or recent ejaculation.

Additional Recommendations

• The patient should avoid ejaculation for 48 hours before any follow-up PSA testing to prevent falsely elevated results.
• The urologist may consider the PSA velocity (rate of change over time) and PSA density (PSA relative to prostate size) in their assessment, as these metrics often provide more clinical context than a single PSA value alone 1.
• The PCPT trial demonstrated that 15% of men with a PSA level of 4.0 ng/mL or less and a normal DRE had prostate cancer, highlighting the importance of further evaluation even with PSA levels below 4 ng/mL 1.

From the FDA Drug Label

1. 1 Effects on Prostate-Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection

In clinical trials, dutasteride reduced serum PSA concentration by approximately 50% within 3 to 6 months of treatment. This decrease was predictable over the entire range of PSA values in subjects with symptomatic BPH, although it may vary in individuals Dutasteride may also cause decreases in serum PSA in the presence of prostate cancer. To interpret serial PSAs in men taking dutasteride, a new PSA baseline should be established at least 3 months after starting treatment and PSA monitored periodically thereafter Any confirmed increase from the lowest PSA value while on dutasteride may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5 alpha-reductase inhibitor. Noncompliance with dutasteride may also affect PSA test results To interpret an isolated PSA value in a man treated with dutasteride for 3 months or more, the PSA value should be doubled for comparison with normal values in untreated men.

The patient's PSA level is 5.79 while on tamsulosin.

• PSA Interpretation: To interpret this PSA value, it should be compared to the patient's baseline PSA level after starting treatment with dutasteride (if the patient was started on dutasteride) or considered in the context of symptoms and other diagnostic factors.
• Next Steps:
  • If the patient is not on dutasteride, consider starting dutasteride and establishing a new PSA baseline after 3-6 months.
  • Monitor the patient's PSA level periodically.
  • Any confirmed increase from the lowest PSA value may signal the presence of prostate cancer and should be evaluated.
  • Consider other diagnostic factors and symptoms to determine the best course of action for the patient 2.

From the Research

Patient with PSA 5.79 and Tamsulosin

• The patient has a Prostate-Specific Antigen (PSA) level of 5.79 and is already on tamsulosin (flomax) 3.
• A study published in 2010 found that tamsulosin treatment can reduce PSA levels in patients with elevated PSA and lower urinary tract symptoms, with a significant decrease in PSA levels observed in patients with negative biopsy findings 3.
• The study also found that a change in PSA level after treatment can be used to identify patients at high risk of prostate cancer, with a sensitivity of 96.6%, specificity of 72.5%, and diagnostic accuracy of 81% 3.

Management Options

• Another study published in 2011 found that dutasteride, alone or in combination with tamsulosin, can reduce the relative risk of prostate cancer diagnosis in men with benign prostatic hyperplasia (BPH) 4.
• The study also found that dutasteride can reduce the likelihood of biopsy and increase the diagnostic yield of prostate cancer on biopsy 4.
• A study published in 2002 found that a high PSA level (≥ 20 ng/mL) is highly accurate in predicting prostate cancer, with a positive predictive value of 95.7% for PSA ≥ 30 ng/mL and 98.5% for PSA ≥ 50 ng/mL 5.
• However, the patient's PSA level is 5.79, which is below the threshold of 20 ng/mL, and therefore, the accuracy of PSA in predicting prostate cancer is lower 5.

Treatment with 5-Alpha Reductase Inhibitors

• A study published in 2013 found that finasteride and dutasteride can reduce PSA levels and prostate volume significantly in patients with BPH, with a significant difference in IPSS, uroflow, and prostate volume at 3 months for dutasteride 6.
• The study also found that PSA reduction is directly correlated with response to therapy, and patients with a PSA reduction of more than half presented a good response and did not require surgical therapy 6.