Abstract
The authors should be congratulated on a successful surgical series without any significant complications. In addition to using PIRADS 5 for inclusion, they also increased the “pretest” probability of clinically significant prostate cancer by selecting men with other high-risk features such as elevated PSA density and concerning digital rectal exam.
The proposal—proceed to organ extirpation and avoid biopsy in cases of suspicious lesion(s) seen on cross-sectional imaging—has been accepted practice for decades in the setting of renal masses. With large or growing renal masses, surgeons commonly proceed to partial nephrectomy or even radical nephrectomy without a microscopic tissue diagnosis. The small probability of removing a benign tumor such as an oncocytoma is accepted. Is a PIRADS 5 prostate lesion by MRI analogous to a renal mass seen by CT?
The scenario should be viewed from the patient’s perspective and a risk-benefit analysis performed. Also, the goal should always be “primum non nocere” or “first do no harm.” Patients frequently fear prostate biopsy, and, on occasion, ask to avoid biopsy and move to treatment. In my experience, patient fears are commonly not founded on evidence-based medicine and can easily be tempered by discussing local sepsis rates and the approach to local anesthetic nerve block. The risk of sepsis from prostate biopsy in modern series is low and even lower with fluoroquinolone resistance testing or utilizing a transperineal approach.
The risks of robotic prostatectomy with pelvic lymph node dissection are significant, well described, and include erectile dysfunction, incontinence, lymphocele, deep venous thrombosis, pulmonary embolism, and death. The list includes both severe (pulmonary embolism/death) and potentially permanent disability (incontinence and erectile dysfunction). Therefore, the performance of MRI PIRADS 5 comes into question. In a recent systemic review and meta-analysis, PIRADS 5 carried an 85% risk of clinically significant cancer (≥Gleason 3 + 4). This varied widely between included studies (65%–100%). 1 What positive predictive value would preclude the need for biopsy? Should we tolerate a 5% rate of unnecessary prostatectomy?
Biopsy results go beyond the binary (cancer vs. no cancer) and give important information to help select the surgical approach (hood, Retzius sparing, etc.) and guide nerve and sphincter sparing steps during the procedure. That is to say, a PIRADS 5 with Gleason 3 + 4 would be treated differently than a PIRADS 5 with Gleason 4 + 5. Furthermore, the biopsy is seen by many or most urologists to be important for proper utilizing of PSMA-PET and genomic studies. Even if biopsy leads to a 1 to 2-month delay of the surgery, that delay may be important for the patient to have relevant staging and understand the treatment options (surveillance, focal therapy, radiation, or surgery).
In summary, the burden of proof for a prostate cancer diagnosis should be high when considering prostatectomy. What’s more, emphasis should be placed on collecting all the relevant data to personalize the treatment approach and informed consent process.