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Many men who have an enlarged prostate (aka, benign prostatic hyperplasia, or BPH) and lower urinary tract symptoms (LUTS) respond to one or more of the numerous treatments that are available, including a variety of oral medications, minimally invasive medical procedures, or invasive surgical techniques. However, when such medical treatment fails and/or surgery is not a suitable option, another alternative is intra-prostatic injections. Are prostate injections for benign prostatic hyperplasia beneficial?
Prostate injections for benign prostatic hyperplasia
Interest in the use of prostate injections for benign prostatic hyperplasia has been increasing recently as an option for men with BPH who are not good candidates for surgery and who suffer with LUTS. To gauge the current state of this treatment approach, a systematic review of the literature up until June 2018 was performed and reported by a team of investigators from Italy and the United States.
Intra-prostatic injections for the treatment of men with LUTS and BPH have included ethanol, onabotulinum toxin A, NX1207, and PRX302. The reviewers concluded that prostate injections for benign prostatic hyperplasia and LUTS should still be considered as an investigational approach.
The findings of ongoing and future randomized controlled trials could provide valuable information as to their possible inclusion to the treatment roster for this prostate condition.
In the meantime, here are some findings from completed studies of these four agents.
- Ethanol. This agent was the first one to be tried for LUTS/BPH. Once it demonstrated serious although rare side effects, it was discontinued as a potential course of treatment.
- Onabotulinum toxin A (BotoxR). An example of the effect of onabotulinum toxin A on LUTS/BPH can be seen in the findings of a multicenter double-blind, randomized, placebo-controlled study. At week 12, the investigators reported significant improvements from baseline for men who received placebo as well as those who were given 100 units, 200 units, or 300 units of the drug. The incidence of adverse effects also were similar across all of the groups.
- NX 1207. In an evidence-based review conducted in Austria, the authors reported that “All published clinical trials of NX1207 have demonstrated a significant improvement in symptomatic BPH.” However, they also point out that patient numbers have been low and that “there should be a large multicenter placebo-controlled validation study using 5 mg NX1207 [the dose found to be effective in trials] with a follow-up of at least 5 years.” Subsequently, however, development of NX 1207 to treat BPH was abandoned in November 2014 after it failed to reach its primary endpoints.
- PRX 302. This drug has shown some promise in phase I and II studies. Experts are awaiting the results of a phase III trial entitled “Randomized, double-blind, vehicle-controlled multicenter safety and efficacy study of intraprostatic PRX302 for LUTS BPH (The PLUS-1 Trial)” before they reach any conclusions.
For now, use of prostate injections for benign prostatic hyperplasia in men who are not good candidates for surgery and who have failed other treatment is still uncertain. Stay tuned.
Chung ASJ, Woo HH. Update on minimally invasive surgery and benign prostatic hyperplasia. Asian Journal of Urology 2018 Jan; 5(1): 22-27
Clinical Trials. Randomized, double-blind, vehicle-controlled multicenter safety and efficacy study of intraprostatic PRX302 for LUTS BPH (The PLUS-1 Trial). ClinicalTrials.gov Identifier: NCT01966614
Kunit T, Lusuardi L. An evidence-based review of NX1207 and its potential in the treatment of benign prostatic hyperplasia. Research and Reports in Urology 2014 Jul 12; 6:67-70
Lombardo R et al. Intraprostatic injections for LUTS/BPH treatment. The Italian Journal of Urology and Nephrology 2018 Oct 3 Epub ahead of print
Marberger M et al. A randomized double-blind placebo-controlled phase 2 dose-ranging study of onabotulinumtoxin A in men with benign prostatic hyperplasia. European Urology 2013 Mar; 63(3): 496-503