Charles Bankhead

R. Caleb Kovell, MDFour-year data on the prostatic urethral lift and data on an investigational water-jet ablation treatment were among BPH/LUTS highlights from this year’s meeting. The BPH/LUTS take-home messages were presented by R. Caleb Kovell, MD, of the University of Pennsylvania, Philadelphia.

Experience with holmium laser enucleation of the prostate (HoLEP) showed linear improvement in enucleation, AUA Symptom Score (AUA-SS) improvement of at least 50% across range of prostate volume, and greater improvement with larger glands.

Four-year follow-up of a trial of the prostatic urethral lift (UroLift, Neotract) in 206 men showed sustained improvement from baseline, including a 46% decrease in International Prostate Symptom Score (IPSS), no sustained erectile or ejaculatory dysfunction, and 19 repeat procedures.

Robot-assisted water-jet ablation (AquaBeam System, PROCEPT BioRobotics) required an average of 38 minutes in the operating room and decreased IPSS from 22.9 to 6.8 at 6 months and increased Qmax from 7.8 to 16.7 cc/sec at 1 year, with no retrograde ejaculation, urinary incontinence, or erectile dysfunction seen.

Ejaculation-sparing thulium laser ablation allowed 165 of 167 patients to leave the hospital without a catheter, led to sustained increase in Qmax, maintenance of ejaculatory function in 56%, and significant decreases in IPSS at 1 and 6 months.

A 10-year follow-up survey of 100 treated with HoLEP showed durable decline in AUA-SS from 21.9 to 5.1, 95% patient satisfaction, 3.5% need for ancillary surgical procedures, and mean PSA value of 1.57 ng/mL.

Continue to the next page for more take-home messages.

		A retrospective study of 434 men with large prostates (>100 cc) treated with 180W laser photovaporization showed a low complication rate until prostate volume exceeded 200 cc.

		A subset analysis of the GOLIATH trial comparing photoselective vaporization of the prostate (PVP) and bipolar transurethral resection of the prostate showed similar improvements in IPSS, IPSS-Quality of Life, Qmax, postvoid residual, prostate volume, and PSA. Better outcomes were seen in PVP patients with respect to mean catheterization time, time to stable health, and length of stay.

		A review of digital rectal exam for the evaluation of benign prostate pathology in 30,500 participants in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial found only marginal clinical utility.

		A subanalysis of REDUCE trial data showed that baseline PSA level predicted subsequent risk of developing lower urinary tract symptoms.

		A prospective ultrasound study showed that structural variation of the prostatic urethra within the prostate (ratio of prostatic urethral length to prostate volume) predicted severity of obstructive symptoms.

		A study of 20 men with LUTS showed that daily tadalafil (Cialis) improved penile endothelial function, IPSS, and penile brachial index.

Next: Study of comb. of an anticholinergic and an alpha-blocker in men with benign prostatic enlargement complicated by OAB

		A study of men with benign prostatic enlargement complicated by overactive bladder showed that the combination of an anticholinergic and an alpha-blocker led to significantly greater improvement in IPSS quality of life scores, OAB total symptoms, and OAB urge symptoms as compared with an alpha-blocker alone.

		An evaluation of 950 men who had prostate surgery for benign or malignant conditions showed a positive linear relationship between improvement in IPSS score post treatment and age. However, when considering percentage improvement, there was a negative linear relationship between percentage improvement change and age.

		Long-term follow-up (median, 50.9 months) after HoLEP enucleation showed that 89% of patients with detrusor underactivity were catheter free and maintained significant improvement in AUA-SS, Qmax, and postvoid residual volume, and 62.5% of patients with acontractility remained catheter free.

		A comparison of prostate tissue specimens after HoLEP showed that men receiving an antiandrogen had similar decreases in blood testosterone and dihydrotestosterone (DHT), adrenal androgen, and prostate DHT and testosterone, whereas men treated with 5-alpha-reductase inhibitors had decreased blood and prostate DHT and marked increases in testosterone and androstenedione.

		Estradiol [10-7M] directly modulated spontaneous smooth muscle contractility within the transition zone of the human prostate, indicating that estrogen may directly influence both the static and dynamic components of BPH.

		A group identified miRNAs that discriminated between the urodynamically defined states of bladder outlet obstruction (BOO)-induced lower urinary tract dysfunction with high sensitivity and specificity. These miRNAs have promising diagnostic performances in patients with urodynamically established BOO with and without detrusor overactivity or with detrusor underactivity and can be potentially used as a tool to evaluate disease progression.

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Articles

Four-year data on the prostatic urethral lift (UroLift) and data on a new water-jet ablation treatment were among BPH/LUTS highlights from this year’s meeting.

BPH: Current, forthcoming modalities show efficacy

-Men with previously treated castration-resistant prostate cancer (CRPC) lived almost 5 months longer when they received the androgen receptor signaling inhibitor enzalutamide, data from an international study showed. 

The secondary endpoints of time to first skeletal-related event and health-related quality of life were also significantly improved in enzalutmide-treated patients versus placebo. 

"[Enzalutamide] is well tolerated and prolongs survival and improves quality of life across the board, making better all secondary measures of health-related outcomes and antitumor activity."			

Data were presented at the American Society of Clinical Oncology annual meeting in Chicago and recently published online in the 

Enzalutamide targets androgen receptor signaling and affects multiple steps in the signaling pathway. The agent has shown no agonistic effect on the androgen receptor in preclinical models. Development of the drug has evolved amid growing recognition that a substantial proportion of men with advanced prostate cancer benefit from second-line hormonal therapy. 

Phase I-II investigation of enzalutamide demonstrated activity in patients with and without prior exposure to chemotherapy. A majority of patients had PSA responses irrespective of chemotherapy history (

 2010; 375:1437-46). The promising results from early studies led to a phase III, randomized, placebo-controlled trial conducted at 156 centers in 15 countries on five continents. The study involved 1,199 patients with progressive CRPC after treatment with docetaxel (Taxotere). 

The patients were randomized 2:1 to either oral enzalutamide, 160 mg/day, or matched placebo. Treatment continued until radiographic evidence of progression by bone scan. 

"This is an important change for us with both the abiraterone and MDV3100 trials," said Dr. de Bono. "The overall aim was to continue therapy despite minor PSA changes. This is very important for clinical practice not to change therapy purely based on PSA changes." 

Men with previously treated castration-resistant prostate cancer (CRPC) lived almost 5 months longer when they received the androgen receptor signaling inhibitor enzalutamide.

Antiandrogen for prostate cancer shows improvement in survival, quality of life

-Repeat surgery occurs two to three times as often after newer minimally invasive interventions for BPH compared with transurethral resection of the prostate (TURP), a review of Medicare claims data showed. 

Overall, four different minimally invasive interventions had repeat surgery rates of about 20%. In contrast, repeat surgery occurred after 8.3% of TURP procedures. In most cases, TURP was the repeat procedure, even among patients who had TURP as the initial treatment, first author Sean Elliott, MD, reported at the AUA annual meeting in Atlanta. 

"Even though TURP might be declining in frequency as the primary procedure for benign prostatic hyperplasia, it still seems to be the go-to procedure for primary treatment failure," Dr. Elliott, associate professor of urologic surgery at the University of Minnesota in Minneapolis, told 

. "I think that probably emphasizes the fact that everyone, regardless of what they use as primary therapy, still recognizes TURP as the gold standard." 

To examine the comparative long-term effectiveness of BPH procedures, Dr. Elliott and colleagues reviewed Medicare records to identify men who underwent BPH surgeries from 2001 through 2007. Using CPT codes, they identified 616,735 patients ages 66 years and older at the time of initial treatment. Duration of follow-up averaged 3.6 years. 

TURP accounted for 51.8% of all the procedures, followed by TUMT (21.4%), laser vaporization (12.2%), laser coagulation (7.6%), and TUNA (7.0%). TURP's share of all procedures declined steadily over the study period, from 19.0% in 2001 to 9.2% in 2007. During the last year of the study period, laser vaporization was the most commonly performed BPH procedure (31.3%), followed by TUMT (17.1%), TUNA (15.2%), TURP, and laser coagulation (8.9%). 

The primary outcome was repeat surgery. Investigators extended the review period to 2008 to capture repeat procedures. The secondary outcome was urologic complications associated with the BPH interventions. 

 The 5-year estimated incidence of repeat BPH surgery ranged from 8.3% with TURP to 25.8% after TUMT. After adjusting for patient and hospital factors, retreatment was 2.1 to 3.5 times more likely with laser vaporization or TUMT, respectively, than with TURP. 

The most common postoperative complication was urethral stricture, occurring in 4.4% of patients overall, including 5.7% of TURP procedures, 2.3% of TUMT procedures, and 2.6% of TUNA procedures (

Bladder-neck contraction occurred in 2.0% of patients overall, including 2.6% with TURP, 2.3% with laser coagulation, 1.6% with vaporization, and <1% with TUMT and TUNA (

"It's nothing new to learn that the complication rate is higher with TURP, although not much higher than with the other two procedures," said Dr. Elliott. "On the other hand, the reoperation rate is dramatically lower with TURP." 

Repeat surgery occurs two to three times as often after newer minimally invasive interventions for BPH compared with transurethral resection of the prostate.

Transurethral resection of the prostate associated with lower risk of repeat procedures

-A robot-assisted laparoscopic radical prostatectomy costs 40% more than a retropubic radical prostatectomy, according to a review of hospital data from one state. 

"High surgical volume was associated with lower cost of radical prostatectomy," said first author Elias S. Hyams, MD, a former endourology fellow at Johns Hopkins University in Baltimore, working with Brian R. Matlaga, MD, MPH, and colleagues. "However, even at high surgical volume centers, the cost of robotic prostatectomy exceeded that of open prostatectomy. 

"As robotic surgery has come to dominate the health care marketplace, strategies to increase the role of high-volume providers may be needed to improve the cost-effectiveness of prostate cancer surgical therapy," added Dr. Hyams, who is now at Dartmouth-Hitchcock Medical Center, Lebanon, NH. 

Total costs comprised several components, including operating room costs, room and board, radiology, pharmaceuticals, laboratory, supplies, and miscellaneous therapies. 

For their analysis, the authors defined high-volume hospitals as facilities that had an annual prostatectomy volume >60 cases. High-volume surgeons were those who performed >40 prostatectomies annually. 

The analysis included 1,499 men who underwent robotic and 2,565 men who had retropubic prostatectomy between 2008 and 2011. The two groups did not differ significantly with respect to age, race, patient complexity level, or proportion of Medicare/Medicaid patients. 

The robotic procedure was associated with a significantly shorter length of stay (1.7 vs. 1.9 days, 

<.001), but the proportion of patients requiring a stay in the intensive care unit did not differ (1.3% amd 1.6% with robotic and retropubic RP, respectively). 

In the robotic surgery group, 50.6% of procedures were performed by high-volume surgeons. In contrast, high-volume surgeons performed 70.2% of retropubic RPs (

<.001). Retropubic RPs also were performed more often at high-volume hospitals (83.3% vs. 74.8%, 

Costs driven by OR, supply charges 							

 During the study period, the cost of a robotic prostatectomy averaged $14,000 compared with $10,100 for retropubic (

<.001). The difference was driven primarily by higher operating room and supply charges. A significant difference persisted even among high-volume hospitals (

Both high-volume surgeons and high-volume hospitals were associated with a lower overall cost for retropubic surgery (

<.001). High surgeon volume was associated with a lower cost of robotic and retropubic RP (

<.001), whereas high hospital volume was associated with a lower cost for robotic RP only (

During the discussion that followed his presentation, Dr. Hyams acknowledged that lack of information about the reported charges and true costs of the procedures was an inherent limitation of the database. 

"It's a proxy for true costs, but it captures a very large percentage of the data within the state, so we're trading some granular detail for statistical power," he said. 

The estimates did not take into consideration the capital costs associated with requiring robotic surgery systems, which would have resulted in even larger differences between the two types of procedures, Dr. Hyams told 

"Those capital costs are sizable, on the order of a couple of million dollars, but it is difficult to estimate the per-procedure premium that robotic technology adds to the total cost of a radical prostatectomy," he said. 

A robot-assisted laparoscopic radical prostatectomy costs 40% more than a retropubic radical prostatectomy, according to a review of hospital data from one state.

Charles Bankhead

Articles

BPH: Current, forthcoming modalities show efficacy

Antiandrogen for prostate cancer shows improvement in survival, quality of life

Transurethral resection of the prostate associated with lower risk of repeat procedures

Robotic radical prostatectomy remains more costly than open technique