Study: Safety, efficacy similar between PVP, TURP

Stockholm, Sweden-Photoselective vaporization of the prostate (PVP) is non-inferior to transurethral resection of the prostate (TURP) in men with benign prostatic obstruction (BPO), researchers reported at the European Association of Urology annual congress in Stockholm, Sweden.

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Study authors presented 1-year follow-up data of the Goliath Study, a large open-label, prospective, European, multicenter, randomized controlled trial that compared GreenLight XPS (American Medical Systems, Minnetonka, MN) PVP and TURP in men with BPO over 6 months. The study’s primary targets were International Prostate Symptom Score (IPSS), maximum flow rate (Qmax), and complication-free rate, with a follow-up time of 2 years.

“An investigation comparing GL-XPS and TURP that included a lengthy follow-up period was vital to prove the safety and efficacy of the laser system and dispel any doubts concerning increased adverse events following XPS,” principal investigator and co-author Alexander Bachmann, MD, told Urology Times.

“We showed at 6 months and again at 1 year after surgery that side effects and complications of XPS laser were non-inferior-meaning comparable-to TURP. In fact, the questionnaires revealed that the re-intervention rate was higher after TURP, as was recovery, again substantiating that side effects are not higher with XPS,” said Dr. Bachmann, chair of urology and head of the Bladder-Kidney-Prostate Tumor Center at the University of Basel in Basel, Switzerland.

The Goliath Study included 291 patients who were enrolled between April 2011 and September 2011 at 29 sites in nine European countries. A total of 281 were randomized and 269 received treatment. Non-inferiority was evaluated using one-sided tests at the 2.5% level of significance. An IPSS margin of 3 was deemed necessary to demonstrate non-inferiority. The trial was also powered to compare Qmax and the complication-free rate at 6 months, evaluated at the two-sided (5%) level.

Next: Non-inferiority shown at 6 months

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Non-inferiority shown at 6 months

At 6 months, the study demonstrated the non-inferiority of PVP to TURP in IPSS. An analysis of secondary endpoints demonstrated that length of catheterization, time until stable health, and length of stay were superior after PVP compared with TURP (p<.001).

The 1-year functional results, which included 95.5% of the patients (PVP, 130; TURP, 127), evaluated International Index of Erectile Dysfunction (IIEF-5), International Consultation on Incontinence Modular Questionnaire–Urinary Incontinence short form (ICIQ-UI SF), and overactive bladder quality of life questionnaire (OAB-q).

The findings showed that IPSS was 7.0 in the PVP arm and 5.7 in the TURP arm (mean difference of 1.3, 95% confidence interval: 0.1–2.7). Qmax was 23.0 in the XPS arm and 24.7 in the TURP arm. The complication-free rate after 12 months was 84.6% for GreenLight XPS patients and 80.5% for TURP patients (p=.415).

IIEF-5, IPSS-QoL, post-void residual, prostate volume, and PSA revealed no significant difference between the two treatment arms at 12 months, while the results of OAB-q and ICIQ-UI SF slightly favored TURP statistically. Conversely, the proportion of subjects with adverse events requiring surgical or invasive interventions was 12.4% after PVP and 15.0% after TURP.

The early postoperative re-intervention rate was three times higher after TURP compared with GreenLight XPS (p=.025); however, the overall postoperative re-intervention rates were not significantly different between treatment arms.

Limitations to the study include a short follow-up time. A study design comprising a 2-year follow-up period was designed to address this.

Dr. Bachmann maintained that these data clearly demonstrate that clinical assessments of efficacy and safety at 6 and 12 months are similar between GreenLight XPS and TURP, contradicting the view that the laser is less efficacious and associated with a higher rate of adverse events compared with TURP. The GreenLight XPS laser system using the MoXy fiber represents a significant improvement over previous GreenLight systems in terms of safety and efficacy, he said.UT

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