Is Optilume BPH Associated with Prostate Cancer?
No, the Optilume BPH procedure is not associated with causing or increasing the risk of prostate cancer. This is a drug-coated balloon catheter system that uses paclitaxel (a chemotherapy agent) to treat benign prostatic hyperplasia, and there is no evidence linking it to prostate cancer development.
Understanding the Optilume BPH System
The Optilume BPH Catheter System is a minimally invasive device that combines mechanical dilation of the prostatic urethra with local delivery of paclitaxel, an anti-proliferative drug 1, 2. The paclitaxel coating is designed to prevent tissue regrowth and maintain urethral patency after dilation, not to treat or cause cancer 3.
Safety Profile and Cancer Risk
Clinical Trial Evidence
- The PINNACLE randomized controlled trial (148 patients) and EVEREST-I study (80 patients) demonstrated no association between Optilume BPH treatment and prostate cancer development 1, 2
- Safety assessments through 1-2 years of follow-up showed common urologic complications (hematuria 15-39.8%, urinary tract infections, dysuria) but no malignancy-related adverse events 1, 3, 2
- The most recent comprehensive review (2025) analyzing all available Optilume studies found no evidence of cancer risk or oncologic complications 3
Mechanism of Action
The paclitaxel used in Optilume works locally to inhibit smooth muscle cell proliferation and scar tissue formation in the prostatic urethra 4. The drug delivery is targeted and localized, designed to prevent benign tissue overgrowth rather than having systemic effects that could influence cancer development 3.
Important Clinical Distinctions
BPH vs Prostate Cancer
It's critical to understand that benign prostatic hyperplasia (BPH) and prostate cancer are distinct entities 5:
- BPH is a benign proliferation of prostatic tissue causing urinary symptoms
- Prostate cancer is a malignant process with different risk factors and pathophysiology
- Treatment of BPH does not cause or prevent prostate cancer 5
Pre-Treatment Evaluation
Standard BPH evaluation should include assessment for prostate cancer before any BPH treatment, including Optilume 5:
- PSA measurement is recommended as part of initial BPH evaluation
- This helps identify patients who may need further cancer screening
- The presence of BPH does not exclude concurrent prostate cancer
Common Pitfall to Avoid
Do not confuse the use of paclitaxel (a chemotherapy drug) in the Optilume device with cancer treatment or cancer causation. The paclitaxel coating serves an entirely different purpose—preventing scar tissue formation—and is delivered at much lower doses locally compared to systemic chemotherapy 1, 4. The drug's anti-proliferative properties work against benign smooth muscle cells in the prostatic urethra, not cancer cells.
Clinical Outcomes Without Cancer Risk
The Optilume BPH system has demonstrated 2:
- 67.5% responder rate (≥30% IPSS improvement) at 2 years
- IPSS reduction from 23.4 to 11.0 points
- Peak flow improvement from 8.9 to 19.0 mL/s
- Preserved sexual function (stable IIEF scores)
- No reported cases of treatment-induced malignancy