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ClinicalTrials.gov NCT01533038.

PUL was compared to TURP in a randomised, controlled study which further characterized both modalities so that care providers and patients can better understand the net benefit when selecting a treatment option.

Objectives• To evaluate the optimal treatment conditions and effects of TOOKAD ® Soluble vascular-targeted photodynamic (VTP) therapy in patients with localised prostate cancer.• To evaluate the safety and quality of life after TOOKAD ® Soluble VTP treatment in patients with localised prostate cancer. Patients and Methods• Men (aged >18 years) diagnosed with localised prostate cancer, who were suitable for active surveillance, were invited to take part in the study. Patients who had received prior or current treatment for their cancer were excluded. • There were two parts to the study: in part one, patients were assigned to one of two treatment groups based on the size of their prostates (patients with prostate size <60 mL would receive 4 mg/kg TOOKAD ® Soluble and patients with prostate size ≥60 mL would receive 6 mg/kg TOOKAD ® Soluble both activated with 200 J/cm light). In part two, patients were assigned to one of two treatment groups based on predefined criteria and received either 4 or 6 mg/kg TOOKAD ® Soluble and 200 or 300 J/cm light.• VTP was conducted under general anaesthesia using TOOKAD ® Soluble administered intravenously and activated by light-diffusing fibres within the prostate via the perineum.• Follow-up was conducted for 6 months. Magnetic resonance imaging (MRI) carried out at 1 week after VTP and transrectal prostate biopsy at 6 months were the key endpoints. Adverse event (AE) recording and patient-reported outcome measures were collected. Results• In all, 86 patients were enrolled in the study and 85 patients received treatment. Of the 85 treated patients, one patient discontinued (due to withdrawal of consent).• At 6 months, 61/83 (74%) patients who underwent prostate biopsy had histopathology that was negative for prostate cancer (95% confidence interval (CI) 62.7-82.6%).Considering patients who received 4 mg/kg TOOKAD ® Soluble and 200 J/cm light (unilateral), which are considered optimal treatment parameters, 38/46 (83%) patients had histopathology from the biopsies that was negative for prostate cancer at 6 months (95% CI 68.6-92.2%; P < 0.001).• The mean percentage of necrosis of the targeted prostate tissue at 7 days after VTP was 78% overall (83 patients) with extraprostatic necrosis reported in 76% (63/83) of patients. Considering patients who received 4 mg/kg TOOKAD ® Soluble and 200 J/cm light (unilateral), the mean 7-day necrosis percentage was 88% (46 patients) with extraprostatic necrosis reported in 72% (33/46) of patients. All occurrences of extraprostatic necrosis were considered clinically acceptable and none were associated with any clinical sequelae.• The mean percentage prostate necrosis at 7 days was statistically significantly higher (P < 0.001) in patients treated with a therapeutic light density index (LDI) of ≥1 than those treated with a LDI of <1. The percentage of patients with negative biopsies at 6 months was also higher in patients treated with a therapeutic LDI of ≥1 than those treated with a LDI of <1 (78.6% and 63.0%, respectively).• In all, 87% (75/86) ...

Surgical prostate resection using Aquablation showed noninferior symptom relief compared to transurethral prostate resection but with a lower risk of sexual dysfunction. Larger prostates (50 to 80 ml) demonstrated a more pronounced superior safety and efficacy benefit. Longer term followup would help assess the clinical value of Aquablation.

Followup at 1 year demonstrated that photoselective vaporization of the prostate produced efficacy outcomes similar to those of transurethral resection of the prostate. The complication-free rates and overall reintervention rates were comparable between the treatment groups.

Prostate Symptom Score (IPSS), a quality-of life (QoL) score, prostate-specific antigen (PSA) level, and prostate volume measured by transrectal ultrasonography (TRUS). RESULTSThe mean ( SD , range) duration of PVP was 81.6 (22.9, 39-150) min, the mean energy used for PVP was 278 (60, 176-443) kJ and the mean duration of catheterization after PVP was 23.0 (17.1, 0-72) h. The mean ( SD ) maximum urinary flow rate improved from 8.0 (3.1) to 18.2 (8.1), 18.5 (9.2), 17.9 (7.8) and 19.3 (9.8) mL/s at 3, 6, 12 and 24 months, respectively. The IPSS and QoL scores showed similar improvements, and there was a statistically significant reduction in PSA level and prostate volume after PVP. There was no major complication and no patient had transurethral resection syndrome or a blood transfusion. CONCLUSIONSThe 80 W KTP laser PVP offers rapid tissue ablation in patients with BOO caused by a large prostate. The short-and medium-term outcomes show that this technique can be a viable alternative to open prostatectomy.