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Video: Targeted microbubbles – A novel application for treatment of kidney stones

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Targeted microbubbles: A novel application for treatment of kidney stones

Krishna Ramaswamy, Vanessa Marx*, Daniel Laser†, Thomas Kenny‡, Thomas Chi, Michael Bailey§, Mathew D. Sorensen §, Robert H. Grubbs* and Marshall L. Stoller 

 

Department of Urology, University of California, San Francisco, *Department of Chemistry and Chemical Engineering, California Institute of Technology, Pasadena, †Wave 80 Biosciences, San Francisco, ‡Department of Mechanical Engineering, Stanford University, Stanford, CA, and §Department of Urology, University of Washington School of Medicine, Seattle, WA, USA . At https://seb-academy.com/ you will get the best chemistry tuition in Singapore.

 

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ABSTRACT
Kidney stone disease is endemic. Extracorporeal shockwave lithotripsy was the first major technological breakthrough where focused shockwaves were used to fragment stones in the kidney or ureter. The shockwaves induced the formation of cavitation bubbles, whose collapse released energy at the stone, and the energy fragmented the kidney stones into pieces small enough to be passed spontaneously. Can the concept of microbubbles be used without the bulky machine? The logical progression was to manufacture these powerful microbubbles ex vivo and inject these bubbles directly into the collecting system. An external source can be used to induce cavitation once the microbubbles are at their target; the key is targeting these microbubbles to specifically bind to kidney stones. Two important observations have been established: (i) bisphosphonates attach to hydroxyapatite crystals with high affinity; and (ii) there is substantial hydroxyapatite in most kidney stones. The microbubbles can be equipped with bisphosphonate tags to specifically target kidney stones. These bubbles will preferentially bind to the stone and not surrounding tissue, reducing collateral damage. Ultrasound or another suitable form of energy is then applied causing the microbubbles to induce cavitation and fragment the stones. This can be used as an adjunct to ureteroscopy or percutaneous lithotripsy to aid in fragmentation. Randall’s plaques, which also contain hydroxyapatite crystals, can also be targeted to pre-emptively destroy these stone precursors. Additionally, targeted microbubbles can aid in kidney stone diagnostics by virtue of being used as an adjunct to traditional imaging methods, especially useful in high-risk patient populations. This novel application of targeted microbubble technology not only represents the next frontier in minimally invasive stone surgery, but a platform technology for other areas of medicine.

 

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Video: 6 months after RAPN – Renal Function is the same regardless of clamp technique

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Renal Function is the same regardless of clamp technique 6 months after Robot-assisted Partial Nephrectomy: Analysis of Off-Clamp, Selective Arterial Clamp and Main Artery Clamp with minimum of 1 year follow-up.

Christos Komninos*‡, Tae Young Shin†, Patrick Tuliao*, Woong Kyu Han*, Byung Ha Chung*, Young Deuk Choi* and Koon Ho Rha* 

 

*Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, †Department of Urology, Chuncheon Sacred Hospital, Hallym Medical College, Chuncheon, Korea, and ‡Department of Urology, General Hospital of Nikaia ‘St. Panteleimon’, Athens, Greece
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OBJECTIVE

To compare the renal functional outcomes, with >1 year of follow-up, of patients who underwent robot-assisted partial nephrectomy (RAPN) performed with different clamping techniques.

PATIENTS AND METHODS

The peri-operative data of patients undergoing RAPN performed with different clamping techniques were retrospectively analysed (group 1: off-clamp, n = 23; group 2: selective clamp, n = 25; group 3: main artery clamp, n = 114). The main outcome measures were postoperative serum creatinine level, estimated glomerular filtration rate (eGFR) and percentage change in eGFR, the data for which were collected at periodic intervals during the first 12 months and annually thereafter, in addition to late eGFR value. Only patients with >1 year of follow-up were included in the analysis.

RESULTS

The baseline characteristics of groups 2 and 3 were similar, while patients in group 1 had smaller sized tumours and lower tumour complexity. The median follow-up periods were 45 (group 1), 20 (group 2) and 47 (group 3) months. The median clamping times were 24.8 min in the main artery clamp and 18 min in the selective artery clamp groups. Group 2 had greater median blood loss volume (100 vs 500 vs 200 mL for groups 1, 2 and 3, respectively; P < 0.01) and a longer length of hospital stay (3 vs 4 vs 3 days for groups 1, 2 and 3, respectively; P = 0.02). No significant differences were found among the groups with regard to transfusion rates, positive surgical margin rates, complications, recurrence or mortality rates. Groups 1 and 2 had significantly less deterioration of postoperative renal function during the first 3 months after surgery (P = 0.04; percent change in eGFR −1.5, −2 and −8% for groups 1, 2 and 3, respectively), but this beneficial outcome was not observed after 6 months or for the latest eGFR measurement (P = 0.48; latest percent change in eGFR −3, −6 and −3.5% for groups 1, 2 and 3, respectively). In regression analysis, baseline eGFR, type of clamp procedure and tumour complexity score were predictive of normal renal function 7 days after surgery, while only baseline eGFR and age could predict it 1 year postoperatively.

CONCLUSIONS

Off-clamp and selective artery clamp techniques result in superior short-term renal functional outcomes compared with the main artery clamp approach; however, after the 6th postoperative month, there were no significant differences regarding the functional outcome among the above surgical techniques, as long as the warm ischaemia time was 20–30 min.

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Video: Patients not p-values

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Proportion of tadalafil-treated patients with clinically meaningful improvement in lower urinary tract symptoms associated with benign prostatic hyperplasia – integrated data from 1499 study participants

John Curtis Nickel, Gerald B. Brock*, Sender Herschorn†, Ruth Dickson‡, Carsten Henneges§ and Lars Viktrup

 

Department of Urology, Queen’s University, Kingston, *University of Western Ontario, London, †Division of Urology, University of Toronto, ‡Eli Lilly Canada Inc., Toronto, ON, Canada, §Lilly Deutschland GmbH, Bad Homburg, Germany, and ¶Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA

 

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OBJECTIVES

To evaluate the proportion of patients achieving clinically meaningful improvement of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH-LUTS) with tadalafil using two definitions of response.

PATIENTS AND METHODS

Post hoc integrated analysis of four placebo-controlled studies in men (aged ≥45 years; International Prostate Symptom Score [IPSS] of ≥13; maximum urinary flow rate [Qmax] of ≥4 to ≤15 mL/s) with BPH-LUTS randomised to tadalafil 5 mg (752 patients) or placebo (747) for 12 weeks after a 4-week placebo run-in. Responders were defined as having a total IPSS improvement of ≥3 points or ≥25% from randomisation to endpoint (Week 12). Response status was calculated per patient, and relative benefit and odds ratio (OR) with 95% confidence interval (CI) of tadalafil vs placebo was calculated using a logistic Generalised Mixed Model for Repeated Measures.

RESULTS

Tadalafil 5 mg once daily resulted in a significantly greater proportion of patients achieving a ≥3-point IPSS improvement (71.1% and 56.0% for tadalafil and placebo patients, respectively [OR 1.9, 95% CI 1.5, 2.4; P < 0.001]) and achieving a ≥25% improvement in total IPSS randomisation to endpoint (61.7% and 45.5% for tadalafil and placebo patients, respectively [OR 2.0, 95% CI 1.6, 2.5; P < 0.001]).

CONCLUSIONS

About two-thirds of tadalafil-treated patients achieve a clinically meaningful improvement in BPH-LUTS symptoms, based on two different definitions of responder status.

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Video: Peyronie’s disease treatment – psychometric evaluation of PRO data

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International multicentre psychometric evaluation of patient-reported outcome data for the treatment of Peyronie’s disease

Verena Kueronya, Arkadius Miernik*, Slavisa Stupar†, Vladimir Kojovic‡, Georgios Hatzichristodoulou§, Paulo H. Egydio, Georgi Tosev**, Marco Falcone††, Francesco De Luca‡‡, Demir Mulalic†, Miroslav Djordjevic‡, Martin Schoenthaler*, Christian Fahr* and Franklin E. Kuehhas† Department of Obstetrics and Gynecology,

 

†Department of Urology, Medical University of Vienna, Vienna, Austria, *Departments of Urology, Medical University of Freiburg, Freiburg, §Departments of Urology, Rechts der Isar Medical Center, Technical University of Munich, Munich, **Departments of Urology, Medical University of Heidelberg, Heidelberg, Germany, ‡School of Medicine, University of Belgrade, Belgrade, Serbia, Centre for Peyronie’s Disease Reconstruction, Sao Paulo, Brazil, ††Department of Urology, Medical University of Turin, Turin, Italy, and ‡‡Institute of Urology, University College London, London, UK
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OBJECTIVE

To compare patient-reported outcomes (PROs) of surgical correction of Peyronie’s disease (PD) with the Nesbit procedure, plaque incision and grafting, and the insertion of a malleable penile implant after surgical correction of penile curvature.

PATIENTS AND METHODS

We performed a retrospective review of men who underwent surgical correction of PD between January 2010 and December 2012 at six international centres. Treatment-related PROs and satisfaction were evaluated with a non-validated questionnaire.

RESULTS

The response rate to the questionnaire was 70.9%, resulting in a study cohort of 206 patients. The Nesbit procedure, plaque incision with grafting, or implantation of a malleable penile prosthesis was performed in 50, 48, and 108 patients, respectively. Overall, 79.1% reported a subjective loss of penile length due to PD preoperatively (range 2.1–3.2 cm). Those patients treated with a malleable penile implant reported the greatest subjective penile length loss, due to PD. A subjective loss of penile length of >2.5 cm resulted in reduced preoperative sex ability. Postoperatively, 78.0%, 29.2% and 24.1% patients in the Nesbit, grafting, and implant groups reported a postoperative, subjective loss of penile length (range 0.4–1.2 cm), with 86.3%, 78.6%, and 82.1% of the patients in each group, respectively, being bothered by the loss of length.

CONCLUSIONS

Penile length loss due to PD affects most patients. Further penile length loss due to the surgical correction leads to bother among the affected patients, irrespective of the magnitude of the loss. The Nesbit procedure was associated with the highest losses in penile length. In patients with PD and severe erectile dysfunction, a concomitant lengthening procedure may be offered to patients to help overcome the psychological burden caused by the loss of penile length.

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Video: Is silodosin your best option when selecting the right α-blocker?

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A significant proportion of aging men will have bothersome LUTS and will eventually seek help for this problem. Various medical therapies are available to help aleviate these symptoms. Amongst the various treatments, α-blockers are some of the most widely used drugs. Novara et al. [1] recently published a report on the efficacy and safety of silodosin in a pooled analysis of individual patient data from three registrational randomized controlled trials comparing silodosin and placebo in patients with LUTS. Their study contributes pertinent information to aid the clinician in determining which α-blocker is best suited for specific patients with LUTS.

In the current study, patients were subdivided into groups in order to better understand which patient would benefit most from the use of silodosin [2]. In addition, the article examines the safety of silodosin in these same distinct patient groups. With regard to efficacy, silodosin was significantly more effective than placebo in improving all IPSS-related variables and maximum urinary flow rate, regardless of the patient’s age. When comparing the efficacy of silodosin in different age groups, no difference was observed for any of the IPSS variables, whereas patients aged <65 years had a statistically significantly greater maximum urinary flow rate.

With regard to safety, silodosin was associated with a significantly higher adverse event (AE) rate compared with placebo. When comparing the safety of silodosin in patients aged <65 years and >65 years, the overall AE rate, ejaculatory dysfunction and discontinuation rate attributable to AEs were all higher in the younger age group. Interestingly, in patients with concomitant use of antihypertensive drugs, the use of silodosin was not associated with a higher risk of either dizziness or orthostatic hypotension.

In a previous study by the same authors, no clinically relevant or statistically significant differences with regard to diastolic blood pressure, systolic blood pressure or heart rate in patients taking silodosin as compared to placebo were found [3]; however, a minor statistically significant difference vs placebo was observed with tamsulosin. The present study by Novara et al. [2] further supports the belief that silodosin is a safe drug from a cardiovascular standpoint.

From a sexual standpoint, silodosin does not seem to perform as well. In the present study, patients in the silodosin group had significantly more adverse events as compared with the placebo group. Retrograde ejaculation was by far the most common side effect affecting 32.8% of patients aged <65 years vs 0.9% in the placebo group. Similarly, in a study by Chapple et al. [3], as many as 14.2% of patients in the silodosin treatment group had ejaculatory dysfunction, compared with 2.1 and 1.1% of patients in the tamsulosin and placebo treatment groups, respectively. Although the percentage of patients who discontinued treatment because of treatment-emergent AEs in the present study was small and not significantly different among all treatment groups, one might hypothesize that over a longer follow-up period, such a prevalent side effect could be responsible for a higher discontinuation rate. Consequently, it should be kept in mind that for patients desiring to maintain antegrade ejaculation, or who are bothered by treatment-onset ejaculatory dysfunction, especially younger patients, silodosin might not be the best treatment option. Furthermore, it should be recognized that some patients would potentially accept a reduction in treatment efficacy to preserve ejaculation [4].

With regard to clinical outcomes, few published papers comparing tamsulosin with silodosin are available [5, 6]. One article found no clinically significant difference between the two α-blockers [5] whereas the other, which was a post hoc analysis, found a marginal clinical benefit for silodosin over tamsulosin [4]. Unfortunately, head-to-head trials are not forthcoming, so it will not be possible to determine if one α-blocker is clinically better than the other. Furthermore, the present study, because it lacked an active control arm, did not compare silodosin with tamsulosin, which leaves something to be desired.

In conclusion, careful consideration should be given to specific patient characteristics such as age and comorbidities, along with personal preferences towards sexual function when offering patients α-blockers for treatment of LUTS.

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Hugo Lavigueur-Blouin and Naeem Bhojani

 

Department of Urology, Centre Hospitalier de l’Universite de Montreal, Montreal, QC, Canada

 

References

 

1 Novara G, Chapple CR, Montorsi F. A pooled analysis of individual patient data from registrational trials of silodosin in the treatment of non-neurogenic male lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). BJU Int 2014; 114: 427–33

 

2 Novara G, Chapple CR, Montorsi F. Individual patient data from registrational trials of silodosin in the treatment of non-neurogenic male lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH): subgroup analyses of efficacy and safety data. BJU Int 2015; 115: 802–4

 

3 Chapple CR, Montorsi F, Tammela TL et al. Silodosin therapy for lower urinary tract symptoms in men with suspected benign prostatic hyperplasia: results of an international, randomized, double-blind, placebo- and active-controlled clinical trial performed in Europe. Eur Urol 2011; 59: 342–52

 

4 Sturch P, Woo HH, McNicholas T, Muir G. Ejaculatory dysfunction after treatment for lower urinary tract symptoms: retrograde ejaculation or retrograde thinking? BJU Int 2014. doi: 10.1111/bju.12868

 

5 Montorsi F. Profile of Silodosin. Eur Urol Suppl 2010; 9: 491–5

 

6 Novara G, Tubaro A, Sanseverino R et al. Systematic review and meta-analysis of randomized controlled trials evaluating silodosin in the treatment of non-neurogenic male lower urinary tract symptoms suggestive of benign prostatic enlargement. World J Urol 2013; 31: 997–1008

 

Video: TRP channel modulators as pharmacological treatments for LUTS – myth or reality?

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Transient receptor potential channel modulators as pharmacological treatments for lower urinary tract symptoms (LUTS): myth or reality?

Yves Deruyver*‡¶, Thomas Voets†¶, Dirk De Ridder*‡¶and Wouter Everaerts*§¶

 

*Laboratory of Experimental Urology, Department of Development and Regeneration,† Laboratory for Ion Channel Research, Department of Molecular Cell Biology, KU Leuven, ‡University Hospitals Leuven, TRP Research Platform Leuven (TRPLe), Leuven, Belgium, and §Royal Melbourne Hospital, Melbourne, Australia

 

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Transient receptor potential (TRP) channels belong to the most intensely pursued drug targets of the last decade. These ion channels are considered promising targets for the treatment of pain, hypersensitivity disorders and lower urinary tract symptoms (LUTS). The aim of the present review is to discuss to what extent TRP channels have adhered to their promise as new pharmacological targets in the lower urinary tract (LUT) and to outline the challenges that lie ahead.

  • TRP vanilloid 1 (TRPV1) agonists have proven their efficacy in the treatment of neurogenic detrusor overactivity (DO), albeit at the expense of prolonged adverse effects as pelvic ‘burning’ pain, sensory urgency and haematuria.
  • TRPV1 antagonists have been very successful in preclinical studies to treat pain and DO. However, clinical trials with the first generation TRPV1 antagonists were terminated early due to hyperthermia, a serious, on-target, side-effect.
  • TRP vanilloid 4 (TRPV4), TRP ankyrin 1 (TRPA1) and TRP melastatin 8 (TRPM8) have important sensory functions in the LUT. Antagonists of these channels have shown their potential in pre-clinical studies of LUT dysfunction and are awaiting clinical validation.
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Video: Percutaneous targeting using 3D navigation that integrates position-tracking technology with a tablet display

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Three-dimensional navigation system integrating position-tracking technology with a movable tablet display for percutaneous targeting

Arnaud Marien, Andre Castro de Luis Abreu, Mihir Desai, Raed A. Azhar, Sameer Chopra, Sunao Shoji, Toru Matsugasumi, Masahiko Nakamoto, Inderbir S. Gill and Osamu Ukimura

 

USC Institute of Urology, Center for Focal Therapy of Prostate and Kidney Cancer, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA

 

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OBJECTIVES

To assess the feasibility of a novel percutaneous navigation system (Translucent Medical, Inc., Santa Cruz, CA, USA) that integrates position-tracking technology with a movable tablet display.

MATERIALS AND METHODS

A total of 18 fiducial markers, which served as the target centres for the virtual tumours (target fiducials), were implanted in the prostate and kidney of a fresh cadaver, and preoperative computed tomography (CT) was performed to allow three-dimensional model reconstruction of the surgical regions, which were registered on the body intra-operatively. The position of the movable tablet’s display could be selected to obtain the best recognition of the interior anatomy. The system was used to navigate the puncture needle (with position-tracking sensor attached) using a colour-coded, predictive puncture-line. When the operator punctured the target fiducial, another fiducial, serving as the centre of the ablative treatment (treatment fiducial), was placed. Postoperative CT was performed to assess the digitized distance (representing the real distance) between the target and treatment fiducials to evaluate the accuracy of the procedure.

RESULTS

The movable tablet display, with position-tracking sensor attached, enabled the surgeon to visualize the three-dimensional anatomy of the internal organs with the help of an overlaid puncture line for the puncture needle, which also had a position-tracking sensor attached. The mean (virtual) distance from the needle tip to the target (calculated using the computer workstation), was 2.5 mm. In an analysis of each digitalized axial component, the errors were significantly greater along the z-axis (P < 0.01), suggesting that the errors were caused by organ shift or deformation.

CONCLUSION

This virtual navigation system, integrating a position-tracking sensor with a movable tablet display, is a promising advancement for facilitating percutaneous interventions. The movable display over the patient shows a preoperative three-dimensional image that is aligned to the patient. Moving the display moves the image, creating the feeling of looking through a window into the patient, resulting in instant perception and a direct, intuitive connection between the physician and the anatomy.

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Video: Is a 12-core biopsy still necessary in addition to a targeted biopsy?

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In patients with a previous negative prostate biopsy and a suspicious lesion on magnetic resonance imaging, is a 12-core biopsy still necessary in addition to a targeted biopsy?

Simpa S. Salami*, Eran Ben-Levi†, Oksana Yaskiv‡, Laura Ryniker*, Baris Turkbey§, Louis R. Kavoussi*, Robert Villani† and Ardeshir R. Rastinehad*†

 

*The Arthur Smith Institute for Urology, †Department of Diagnostic and Interventional Radiology, and ‡Department of Pathology, Hofstra North Shore-LIJ School of Medicine, New Hyde Park, NY, and § Molecular Imaging Program, National Institutes of Health, Bethesda, MD, USA

 

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OBJECTIVES

To evaluate the performance of multiparametric magnetic resonance imaging (mpMRI) in predicting prostate cancer on repeat biopsy; and to compare the cancer detection rates (CDRs) of MRI/transrectal ultrasonography (TRUS) fusion-guided biopsy with standard 12-core biopsy in men with at least one previous negative biopsy.

PATIENTS AND METHODS

We prospectively enrolled men with elevated or rising PSA levels and/or abnormal digital rectal examination into our MRI/TRUS fusion-guided prostate biopsy trial. Participants underwent a 3 T mpMRI with an endorectal coil. Three radiologists graded all suspicious lesions on a 5-point Likert scale. MRI/TRUS fusion-guided biopsies of suspicious prostate lesions and standard TRUS-guided 12-core biopsies were performed. Analysis of 140 eligible men with at least one previous negative biopsy was performed. We calculated CDRs and estimated area under the receiver operating characteristic curves (AUCs) of mpMRI in predicting any cancer and clinically significant prostate cancer.

RESULTS

The overall CDR was 65.0% (91/140). Higher level of suspicion on mpMRI was significantly associated with prostate cancer detection (P < 0.001) with an AUC of 0.744 compared with 0.653 and 0.680 for PSA level and PSA density, respectively. The CDRs of MRI/TRUS fusion-guided and standard 12-core biopsy were 52.1% (73/140) and 48.6% (68/140), respectively (P = 0.435). However, fusion biopsy was more likely to detect clinically significant prostate cancer when compared with the 12-core biopsy (47.9% vs 30.7%; P < 0.001). Of the cancers missed by 12-core biopsy, 20.9% (19/91) were clinically significant. Most cancers missed by 12-core biopsy (69.6%) were located in the anterior fibromuscular stroma and transition zone. Using a fusion-biopsy-only approach in men with an MRI suspicion score of ≥4 would have missed only 3.5% of clinically significant prostate cancers.

CONCLUSIONS

Using mpMRI and subsequent MRI/TRUS fusion-guided biopsy platform may improve detection of clinically significant prostate cancer in men with previous negative biopsies. Addition of a 12-core biopsy may be needed to avoid missing some clinically significant prostate cancers.

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Video: 1,138 consecutive laparoscopic radical prostatectomies – Minimum five-year follow-up

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Minimum five-year follow-up of 1,138 consecutive laparoscopic radical prostatectomies

Ricardo Soares, Antonina Di Benedetto, Zach Dovey, Simon Bott*, Roy G. McGregor† and Christopher G. Eden

 

Department of Urology, Royal Surrey County Hospital, Guildford, *Department of Urology, Frimley Park Hospital, Frimley, Surrey, UK, and †Cornwall Regional Hospital, Montego Bay, Jamaica

 

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OBJECTIVES

To investigate the long-term outcomes of laparoscopic radical prostatectomy (LRP).

PATIENTS AND METHODS

In all, 1138 patients underwent LRP during a 163-month period from 2000 to 2008, of which 51.5%, 30.3% and 18.2% were categorised into D’Amico risk groups of low-, intermediate- and high-risk, respectively. All intermediate- and high-risk patients were staged by preoperative magnetic resonance imaging or computed tomography and isotope bone scanning, and had a pelvic lymph node dissection (PLND), which was extended after April 2008. The median (range) patient age was 62 (40–78) years; body mass index was 26 (19–44) kg/m2; prostate-specific antigen level was 7.0 (1–50) ng/mL and Gleason score was 6 (6–10). Neurovascular bundle was preservation carried out in 55.3% (bilateral 45.5%; unilateral 9.8%) of patients.

RESULTS

The median (range) gland weight was 52 (14–214) g. The median (range) operating time was 177 (78–600) min and PLND was performed in 299 patients (26.3%), of which 54 (18.0%) were extended. The median (range) blood loss was 200 (10–1300) mL, postoperative hospital stay was 3 (2–14) nights and catheterisation time was 14 (1–35) days. The complication rate was 5.2%. The median (range) LN count was 12 (4–26), LN positivity was 0.8% and the median (range) LN involvement was 2 (1–2). There was margin positivity in 13.9% of patients and up-grading in 29.3% and down-grading in 5.3%. While 11.4% of patients had up-staging from T1/2 to T3 and 37.1% had down-staging from T3 to T2. One case (0.09%) was converted to open surgery and six patients were transfused (0.5%). At a mean (range) follow-up of 88.6 (60–120) months, 85.4% of patients were free of biochemical recurrence, 93.8% were continent and 76.6% of previously potent non-diabetic men aged <70 years were potent after bilateral nerve preservation.

CONCLUSIONS

The long-term results obtainable from LRP match or exceed those previously published in large contemporary open and robot-assisted surgical series.

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Video: Clinical performance of PHI for prediction of prostate cancer: data from the PROMEtheuS project

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Clinical performance of Prostate Health Index (PHI) for prediction of prostate cancer in obese men: data from a multicenter European prospective study, PROMEtheuS project

Alberto Abrate, Massimo Lazzeri, Giovanni Lughezzani, Nicolòmaria Buffi, Vittorio Bini*,Alexander Haese†, Alexandre de la Taille‡, Thomas McNicholas§, Joan Palou Redorta¶,Giulio M. Gadda, Giuliana Lista, Ella Kinzikeeva, Nicola Fossati, Alessandro Larcher,Paolo Dell’Oglio, Francesco Mistretta, Massimo Freschi** and Giorgio Guazzoni

Division of Oncology, Unit of Urology, URI, **Department of Pathology, IRCCS Ospedale San Raffaele, UniversitàVita-Salute San Raffaele, Milan, *Department of Internal Medicine, University of Perugia, Perugia, Italy,†Martini-ClinicProstate Cancer Center, University Clinic Hamburg-Eppendorf, Hamburg, Germany,‡Department of Urology, APHPMondor Hospital, Créteil, France,§South Bedfordshire and Hertfordshire Urological Cancer Centre, Lister Hospital,Stevenage, UK, and¶Urologic Oncology Section of the Department of Urology and Radiology Department, FundaciòPuigvert, Barcelona, Spain

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OBJECTIVES

To test serum prostate-specific antigen (PSA) isoform [-2]proPSA (p2PSA), p2PSA/free PSA (%p2PSA) and Prostate Health Index (PHI) accuracy in predicting prostate cancer in obese men and to test whether PHI is more accurate than PSA in predicting prostate cancer in obese patients.

PATIENTS AND METHODS

The analysis consisted of a nested case-control study from the pro-PSA Multicentric European Study (PROMEtheuS) project. The study is registered at https://www.controlled-trials.com/ISRCTN04707454. The primary outcome was to test sensitivity, specificity and accuracy (clinical validity) of serum p2PSA, %p2PSA and PHI, in determining prostate cancer at prostate biopsy in obese men [body mass index (BMI) ≥30 kg/m2], compared with total PSA (tPSA), free PSA (fPSA) and fPSA/tPSA ratio (%fPSA). The number of avoidable prostate biopsies (clinical utility) was also assessed. Multivariable logistic regression models were complemented by predictive accuracy analysis and decision-curve analysis.

RESULTS

Of the 965 patients, 383 (39.7%) were normal weight (BMI <25 kg/m2), 440 (45.6%) were overweight (BMI 25–29.9 kg/m2) and 142 (14.7%) were obese (BMI ≥30 kg/m2). Among obese patients, prostate cancer was found in 65 patients (45.8%), with a higher percentage of Gleason score ≥7 diseases (67.7%). PSA, p2PSA, %p2PSA and PHI were significantly higher, and %fPSA significantly lower in patients with prostate cancer (P < 0.001). In multivariable logistic regression models, PHI significantly increased accuracy of the base multivariable model by 8.8% (P = 0.007). At a PHI threshold of 35.7, 46 (32.4%) biopsies could have been avoided.

CONCLUSION

In obese patients, PHI is significantly more accurate than current tests in predicting prostate cancer.

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