Prosta-One Special Precautions

General: Patients with large residual urine volume and/ or severely diminished urinary flow should be carefully monitored for obstructive uropathy.
Effects on prostate-specific antigen (PSA) and prostate cancer detection: No clinical benefit has yet been demonstrated in patients with prostate cancer treated with Finasteride.
Digital rectal examination, as well as other evaluations for prostate cancer, should be carried out on patients with BPH prior to initiating therapy with Finasteride and periodically thereafter, Generally, when PSA assays are performed baseline PSA. 10ng/ml (Hybritech) prompts further evaluation and consideration of biopsy; for PSA levels between 4 and 10 mg/ml, further evaluation is advisable. There is considerable overlap in PSA levels among men with and without prostate cancer. Therefore, in men with BPH, PSA values within the normal reference range do not rule out prostate cancer regardless of treatment of Finasteride A baseline PSA, 4 mg/ml does not exclude prostate cancer. Finasteride causes a decrease in serum PSA concentrations by approximately 50% in patients with BPH even in the presence of prostate cancer. This decrease in serum PSA levels in patients with BPH treated with Finasteride should be considered when evaluating PSA data and does not rule out concomitant prostate cancer.
This decrease is predictable over the entire range of PSA values, although it may vary in individual patients. In patients treated with Finasteride for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men. This adjustment preserves the sensitivity and specificity of the PSA assay and maintains its ability to detect prostate cancer. Any sustained increase in PSA levels of patients treated with Finasteride should be carefully evaluated including consideration of non-compliance to therapy with Finasteride. Percent free PSA (free to total PSA ratio) is not significantly decreased by Finasteride and remains constant even under the influence of Finasteride. When percent free PSA is used as an aid in the detection of prostate cancer, no adjustment is necessary.