What is the appropriate management for a 97-year-old male with Benign Prostatic Hyperplasia (BPH), bilateral simple renal cysts, and a slightly elevated Prostate-Specific Antigen (PSA) level of 10, currently treated with doxazosin (Cardura) and finasteride (Proscar)?

From the Guidelines

The current management approach for this 97-year-old male with BPH appears appropriate, and no additional interventions are necessary at this time, with continuation of combination therapy with doxazosin (Cardura) 2mg daily and finasteride (Proscar) 5mg daily being the most effective treatment option for patients with LUTS associated with demonstrable prostatic enlargement, as supported by the AUA guideline 1. The patient's stable symptoms, despite occasional slow stream and nocturia twice nightly, and the slight PSA elevation to 10 (from 9.0), which is considered age-adjusted and not concerning enough to warrant a prostate biopsy at his advanced age, support this decision. The renal cysts, including the 4.9cm cyst in the right upper pole with a thin septum, are simple and require no intervention based on the recent sonogram findings, as they do not affect the patient's urinary function or overall health. The prostate is enlarged (135g) but with minimal post-void residual, indicating adequate bladder emptying despite the reduced flow rate (Qmax 7ml/s), which is consistent with the expected effects of combination therapy on prostate size and urinary function, as reported in the 2021 AUA guideline 1. Given his age and stable symptoms, continuing the current medication regimen with regular follow-up in 6 months is reasonable, with behavioral modifications such as limiting evening fluid intake and avoiding bladder irritants (caffeine, alcohol) being reinforced to help manage nocturia. No additional testing or medication changes are indicated based on the current clinical picture, as the patient's symptoms are well-managed, and the risks associated with further intervention, such as prostate biopsy or changes to the medication regimen, outweigh the potential benefits, especially considering the patient's advanced age and comorbidities. The use of 5-ARIs, such as finasteride, has been shown to reduce the risk of clinical progression, including acute urinary retention and the need for BPH-related surgery, as reported in the REDUCE trial, and to improve standardized symptom scores, as observed in numerous robust analyses of randomized, placebo-controlled trials with finasteride 1. Therefore, the current management approach, which includes combination therapy with doxazosin and finasteride, is the most appropriate course of action for this patient, with the goal of maintaining his current level of urinary function and quality of life, while minimizing the risks associated with further intervention.

From the FDA Drug Label

1.1 Monotherapy Finasteride tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:

• Improve symptoms
• Reduce the risk of acute urinary retention
• Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.

1.2 Combination with Alpha-Blocker Finasteride tablets administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥ 4 point increase in American Urological Association (AUA) symptom score).

The patient is already on combination pharmacotherapy with finasteride and doxazosin, which is indicated for the treatment of symptomatic BPH. The patient's symptoms are stable, and the current treatment regimen is effective in managing the symptoms.

• The patient's PSA level is 10, which is slightly elevated, but the age-adjusted PSA level is not explicitly mentioned in the drug label.
• The patient has a history of BPH and simple renal cysts, but the drug label does not provide information on the management of these conditions in relation to the patient's current treatment regimen.
• The patient is not experiencing any adverse effects from the current treatment regimen that would necessitate a change in treatment.

Based on the information provided, no changes to the current treatment regimen are necessary at this time. The patient should continue with the combination pharmacotherapy and follow-up in 6 months to monitor the patient's condition and adjust the treatment regimen as needed. 2 3

From the Research

Patient Assessment

• The patient is a 97-year-old male with a history of Benign Prostatic Hyperplasia (BPH) and bilateral simple renal cysts, with the largest cyst being 4.9 cm in the right upper pole.
• The patient is currently on combination pharmacotherapy with Cardura (doxazosin) and Proscar (finasteride), and reports satisfaction with micturition.
• The patient experiences occasional slow stream and nocturia x2, but denies dysuria, fever, hematuria, and any new genitourinary complaints.

Treatment Efficacy

• Studies have shown that finasteride improves long-term urinary symptoms in patients with BPH, but is less effective than doxazosin 4.
• Combination therapy with doxazosin and finasteride has been shown to improve symptoms significantly better than finasteride monotherapy 4, 5, 6.
• The Medical Therapy of Prostatic Symptoms study found that combination therapy with doxazosin and finasteride reduced the risk of clinical progression of BPH by 66% compared to placebo 7.
• Another study found that doxazosin was effective in improving urinary symptoms and flow rate, and was more effective than finasteride alone or placebo 8.

Considerations for Continued Treatment

• The patient's current treatment regimen with doxazosin and finasteride appears to be effective in managing his BPH symptoms.
• The patient's slight increase in PSA (10) is age-adjusted, and no prostate biopsy is necessary at this time.
• The implications of simple renal cysts have been discussed with the patient, and continued monitoring is recommended.
• Behavioral modifications and continued combination pharmacotherapy are recommended, with follow-up in 6 months.