What are the appropriate discussions and follow-up for a 78-year-old male with low-grade, low-volume, Gleason 6 prostate cancer on active surveillance, presenting with symptoms of urinary obstruction, including slow stream, feeling of incomplete evacuation, and nocturia, despite taking Flomax (tamsulosin)?

From the Guidelines

Today's visit should focus on addressing the patient's persistent lower urinary tract symptoms (LUTS) despite Flomax therapy, while also discussing his active surveillance for prostate cancer. I recommend increasing his LUTS management by either optimizing his current tamsulosin (Flomax) dose to 0.8mg daily if not already at maximum, or adding a second medication such as finasteride 5mg daily, as suggested by the 2023 European Association of Urology guidelines on the management of non-neurogenic male lower urinary tract symptoms 1. Additionally, the patient should undergo a post-void residual measurement today to assess for urinary retention, as recommended by the same guidelines 1. For his prostate cancer surveillance, I would order a repeat PSA test in 3 months and schedule his next prostate biopsy at the 2-year mark from his initial diagnosis (approximately 1 year from now), as standard active surveillance protocols typically include biopsies every 1-2 years, and the patient's recent MRI showing no PIRADS lesions is reassuring, but continued monitoring is essential, as outlined in the NCCN clinical practice guidelines in oncology: prostate cancer 1. The patient's symptoms of slow stream, incomplete emptying, and nocturia despite alpha-blocker therapy suggest either progression of his benign prostatic hyperplasia or potentially inadequate dosing of his current medication. Adding a 5-alpha reductase inhibitor like finasteride can provide additional symptom relief by reducing prostate size over time. Behavioral modifications should also be discussed, including:

• limiting fluid intake before bedtime
• avoiding bladder irritants like caffeine and alcohol
• practicing double voiding techniques to improve bladder emptying, as recommended by the 2023 European Association of Urology guidelines on the management of non-neurogenic male lower urinary tract symptoms 1. It is essential to weigh the benefits and drawbacks of active surveillance, as outlined in the NCCN clinical practice guidelines in oncology: prostate cancer, including the advantages of avoiding unnecessary treatment and retaining quality of life, against the disadvantages of potential cancer progression or metastasis before treatment 1. However, given the patient's low-grade, low-volume prostate cancer and his age, active surveillance remains a reasonable approach, with careful monitoring and regular follow-up to adjust the treatment plan as needed.

From the FDA Drug Label

14 CLINICAL STUDIES Four placebo-controlled clinical studies and one active-controlled clinical study enrolled a total of 2296 patients (1003 received Tamsulosin Hydrochloride Capsules 0.4 mg once daily, 491 received Tamsulosin Hydrochloride Capsules 0.8 mg once daily, and 802 were control patients) in the U.S. and Europe.

The primary efficacy assessments included: 1) total American Urological Association (AUA) Symptom Score questionnaire, which evaluated irritative (frequency, urgency, and nocturia), and obstructive (hesitancy, incomplete emptying, intermittency, and weak stream) symptoms, where a decrease in score is consistent with improvement in symptoms; and 2) peak urine flow rate, where an increased peak urine flow rate value over baseline is consistent with decreased urinary obstruction.

The patient is experiencing slow stream, feeling of incomplete evacuation, and nocturia x3, despite taking Flomax (tamsulosin).

• The total AUA Symptom Score is used to evaluate the symptoms of BPH, which includes irritative and obstructive symptoms.
• The patient's symptoms are consistent with obstructive symptoms, which are hesitancy, incomplete emptying, intermittency, and weak stream.
• The peak urine flow rate is also an important measure of urinary obstruction.
• The patient's current medication, Flomax (tamsulosin), has been shown to improve total AUA Symptom Score and peak urine flow rate in clinical studies 2.
• However, the patient is still experiencing symptoms, so it may be necessary to adjust the treatment plan.
• Follow-up appointments should be scheduled to monitor the patient's symptoms and adjust the treatment plan as needed.

From the Research

Discussion Points for Today's Visit

• The patient's symptoms of slow stream, feeling of incomplete evacuation, and nocturia x3, despite taking Flomax, should be discussed in the context of his benign prostatic hyperplasia (BPH) and prostate cancer diagnosis 3, 4.
• The patient's PSA results and MRI findings from March 2024, which revealed no evidence of high-grade PIRAD lesion, should be reviewed to assess the current status of his prostate cancer 5, 6.
• The use of 5-alpha-reductase inhibitors (5-ARIs) for BPH treatment in the context of active surveillance for prostate cancer should be discussed, considering the patient's current symptoms and the potential benefits and risks of 5-ARI use 3, 4, 7.
• The importance of adhering to the active surveillance protocol, including regular PSA testing and biopsy, should be emphasized to ensure the patient's safety and to monitor for any signs of disease progression 5, 6.

Appropriate Follow-up

• Schedule a follow-up appointment to review the patient's PSA results and to assess his symptoms and response to treatment.
• Consider adjusting the patient's medication regimen or adding additional treatments to manage his BPH symptoms.
• Continue to monitor the patient's prostate cancer with regular PSA testing and biopsy, as per the active surveillance protocol.
• Discuss the potential benefits and risks of 5-ARI use with the patient and consider adjusting his treatment plan accordingly 7.