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Video: Patterns of prescription and adherence to EAU guidelines on ADT in PCa

Patterns of prescription and adherence to European Association of Urology guidelines on androgen deprivation therapy in prostate cancer: an Italian multicentre cross-sectional analysis from the Choosing Treatment for Prostate Cancer (CHOICE) study

Giuseppe Morgia1, Giorgio Ivan Russo1, Andrea Tubaro2, Roberto Bortolus3, Donato Randone4, Pietro Gabriele5, Fabio Trippa6, Filiberto Zattoni7, Massimo Porena8Vincenzo Mirone9, Sergio Serni10, Alberto Del Nero11, Giancarlo Lay12 , Umberto Ricardi13, Francesco Rocco14, Carlo Terrone15, Arcangelo Pagliarulo16, Giuseppe Ludovico17, Giuseppe Vespasiani18, Maurizio Brausi19, Claudio Simeone20, Giovanni Novella21, Giorgio Carmignani22, Rosario Leonardi23, Paola Pinnaro5, Ugo De Paula24Renzo Corvo25, Raffaele Tenaglia26, Salvatore Siracusano27, Giovanna Mantini28, Paolo Gontero29, Gianfranco Savoca30 and Vincenzo Ficarra31 (Members of the LUNA Foundation, Societa Italiana dUrologia)

 

Department of Urology, University of Catania, Catania, Department of Urology, Sant Andrea Hospital, La Sapienza’ University of Roma, Roma, S.O. Oncologia Radioterapica, Pordenone, Urology, Presidio Ospedaliero Gradenigo, Torino, Radiotherapy, IRCC Candiolo, Torino, Radiotherapy, A.O. Santa Maria, Terni, Department of Urology, University of Padova, Padova, Department of Urology, University of Perugia, Perugia, Department of Urology, Universita Federico II of Napoli, Napoli,
10 Department of Urology, University of Firenze, Firenze, 11 Urologia I, Azienda Ospedaliera San Paolo, Milano, 12 Radiotherapy, ASL of Cagliari, Cagliari, 1Radiotherapy, AOU University S. Giovanni Battista Molinette, Torino, 14 Department of Urology, University of Milano, Milano, 15Urology, University Hospital Maggioredella Carita, Novara,16 Urology, University of Bari, Bari, 17 Urology, Ospedale Generale Regionale F. Miulli, Acquaviva delle Fonti, 18 Department of Urology, University Tor Vergata, Roma, 19 Urology, Ospedale Civile Ramazzini, Carpi, 20 Department of Urology, University of Brescia, Brescia, 21 Department of Surgery, Urology Clinic, AOUI Verona, Verona, 22 Department of Urology, University of Genova, Genova, 23 Urology, Centro Uro-Andrologico La CURA, Acireale, 24 Radiotherapy, AO S. Giovanni Addolorata, Roma, 25 Radiotherapy, Istituto Nazionale per la Ricerca, Genova, 26 Department of Urology, University of Chieti, Chieti, 27 Department of Urology, University of Trieste, Trieste, 28 Radiotherapy, Policlinico Universitario Agostino Gemelli, Roma, 29 Department of Surgical Sciences, Città della Salutee della Scienza, University of Torino, Torino, 30 Urology, Fondazione Istituto San Raffaele G. Giglio di Cefalù, Cefalù, and 31 Department of Experimental and Clinical Medical Sciences, University of Udine, Udine, Italy

 

Objective

To evaluate both the patterns of prescription of androgen deprivation therapy (ADT) in patients with prostate cancer (PCa) and the adherence to European Association of Urology (EAU) guidelines for ADT prescription.

Methods

The Choosing Treatment for Prostate Cancer (CHOICE) study was an Italian multicentre cross-sectional study conducted between December 2010 and January 2012. A total of 1 386 patients, treated with ADT for PCa (first prescription or renewal of ADT), were selected. With regard to the EAU guidelines on ADT, the cohort was categorized into discordant ADT (Group A) and concordant ADT (Group B).

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Results

The final cohort included 1 075 patients with a geographical distribution including North Italy (n = 627, 58.3%), Central Italy (n = 233, 21.7%) and South Italy (n = 215, 20.0%). In the category of patients treated with primary ADT, a total of 125 patients (56.3%) were classified as low risk according to D’Amico classification. With regard to the EAU guidelines, 285 (26.51%) and 790 patients (73.49%) were classified as discordant (Group A) and concordant (Group B), respectively. In Group A, patients were more likely to receive primary ADT (57.5%, 164/285 patients) than radical prostatectomy (RP; 30.9%, 88/285 patients), radiation therapy (RT; 6.7%, 19/285 patients) or RP + RT (17.7%, 14/285 patients; P < 0.01). Multivariate logistic regression analysis, adjusted for clinical and pathological variables, showed that patients from Central Italy (odds ratio [OR] 2.86; P < 0.05) and South Italy (OR 2.65; P < 0.05) were more likely to receive discordant ADT.

Conclusion

EAU guideline adherence for ADT was low in Italy and was influenced by geographic area. Healthcare providers and urologists should consider these results in order to quantify the inadequate use of ADT and to set policy strategies to overcome this risk.

Video: Nephron-Sparing Surgery Across the UK

Nephron-sparing surgery across a nation – outcomes from the British Association of Urological Surgeons 2012 national partial nephrectomy audit

Archie Fernando*, Sarah Fowler* and Tim OBrien*, on behalf of the British
Association of Urological Surgeons (BAUS) 

 

*BAUS, The Royal College of Surgeons of England, and The Urology Centre, Guys and St Thomas NHS Foundation Trust, London, UK

 

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Objective

To determine the scope and outcomes of nephron-sparing surgery (NSS), i.e. partial nephrectomy, across the UK and in so doing set a realistic benchmark and identify fresh contemporary challenges in NSS.

Patients and Methods

In 2012 reporting of outcomes of all types of nephrectomy became mandatory in the UK. In all, 148 surgeons in 86 centres prospectively entered data on 6 042 nephrectomies undertaken in 2012. This study is a retrospective analysis of the NSS procedures in the dataset.

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Results

A total of 1 044 NSS procedures were recorded and the median (range) surgical volume was 4 (1–39) per consultant and 8 (1–59) per centre. In all, 36 surgeons and 10 centres reported on only one NSS. The indications for NSS were: elective with a tumour of ≤4.5 cm in 59%, elective with a tumour of >4.5 cm in 10%, relative in 7%, imperative in 12%, Von Hippel–Lindau in 1%, and unknown in 11%. The median (range) tumour size was 3.4 (0.8–30) cm. The technique used was minimally invasive surgery in 42%, open in 58%, with conversions in 4%. The histology results were: malignant in 80%, benign in 18%, and unknown in 2%. In patients aged <40 years 36% (36/101) had benign histology vs 17% (151/874) of those aged ≥40 years (P < 0.01). In patients with tumours of <2.5 cm 29% (69/238) had benign histology vs 14% (57/410) with tumours of 2.5–4 cm vs 8% (16/194) with tumours of ≥4 cm (P = 0.02). In patients aged <40 years with of tumours of <2.5 cm 44% (15/34) were benign. The 30-day mortality was 0.1% (1/1 044). There were major complications (Clavien–Dindo grade of ≥IIIa) in 5% (53/1 044). There was an increased risk of complications after extended elective NSS of 19% (19/101) vs elective at 12% (76/621) (relative risk [RR] 1.54; P < 0.01). Margins were recorded in 68% (709/1 044) of the patients, with positive margins identified in 7% (51/709). Positive surgical margins after NSS for pathological T3 (pT3) tumours were found in 47.8% (11/23) vs 6.1% (32/523) for pT1a, tumours (RR 5.61; P < 0.01). In all, 14% (894/6 042) of the patients underwent surgery for T1a tumours: 55% (488/894) by NSS, 42% (377/894) by radical nephrectomy (RN), and in 3% (29/894) the procedure used was unknown. Major complications after occurred in 4.9% (24/488) of NSS vs 1.3% (5/377) of RN (P < 0.01). Limitations included poor reporting of renal function data and no data on tumour complexity.

Conclusions

In its first year, mandatory national reporting has provided several challenging contemporary insights into NSS.

Video: Health resource use after robot-assisted surgery vs open and conventional laparoscopic techniques

Health resource use after robot-assisted surgery vs open and conventional laparoscopic techniques in oncology: analysis of English secondary care data for radical prostatectomy and partial nephrectomy

David Hughes*† ,Charlotte Camp*, Jamie OHara*† and Jim Adshead

 

*HCD Economics, Daresbury, Faculty of Health and Social Care, University of Chester, Chester, and Hertfordshire and South Bedfordshire Urological Cancer Centre, Department of Urology, Lister Hospital, Stevenage, UK

 

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Objectives

To evaluate postoperative health resource utilisation and secondary care costs for radical prostatectomy and partial nephrectomy in National Health Service (NHS) hospitals in England, via a comparison of robot-assisted, conventional laparoscopic and open surgical approaches.

Patients and Methods

We retrospectively analysed the secondary care records of 23 735 patients who underwent robot-assisted (RARP, n = 8 016), laparoscopic (LRP, n = 6 776) or open radical prostatectomy (ORP, n = 8 943). We further analysed 2 173 patients who underwent robot-assisted (RAPN,n = 365), laparoscopic (LPN, n = 792) or open partial nephrectomy (OPN, n = 1 016). Postoperative inpatient admissions, hospital bed-days, excess bed-days and outpatient appointments at 360 and 1 080 days after surgery were reviewed.

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Results

Patients in the RARP group required significantly fewer inpatient admissions, hospital bed-days and excess bed-days at 360 and 1 080 days than patients undergoing ORP. Patients undergoing ORP had a significantly higher number of outpatient appointments at 1 080 days. The corresponding total costs were significantly lower for patients in the RARP group at 360 days (£1679 vs £2031 for ORP; P < 0.001) and at 1 080 days (£3461 vs £4208 for ORP; P < 0.001). In partial nephrectomy, Patients in the RAPN group required significantly fewer inpatient admissions and hospital bed-days at 360 days compared with those in the OPN group; no significant differences were observed in outcomes at 1 080 days. The corresponding total costs were lower for patients in the RAPN group at 360 days (£779 vs £1242 for OPN,P = 0.843) and at 1 080 days (£2122 vs £2889 for ORP; P = 0.570). For both procedure types, resource utilisation and costs for laparoscopic surgeries lay at the approximate midpoint of those for robot-assisted and open surgeries.

Conclusion

Our analysis provides compelling evidence to suggest that RARP leads to reduced long-term health resource utilisation and downstream cost savings compared with traditional open and laparoscopic approaches. Furthermore, despite the limitations that arise from the inclusion of a small sample, these results also suggest that robot-assisted surgery may represent a cost-saving alternative to existing surgical options in partial nephrectomy. Further exploration of clinical cost drivers, as well as an extension of the analysis into subsequent years, could lend support to the wider commissioning of robot-assisted surgery within the NHS.

Video: Gleason Grading in the Spotlight

The impact of the 2005 International Society of Urological Pathology consensus guidelines on Gleason grading – a matched pair analysis

Kasper D. Berg*, Frederik B. Thomsen*, Camilla Nerstrøm*, Martin A. Røder*, Peter Iversen*, Birgitte G. Toft, Ben Vainer† and Klaus Brasso*

 

*Department of Urology, Copenhagen Prostate Cancer Center and Department of Pathology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark

 

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Objectives

To investigate whether the International Society of Urological Pathology (ISUP) 2005 revision of the Gleason grading system has influenced the risk of biochemical recurrence (BCR) after radical prostatectomy (RP), as the new guideline implies that some prostate cancers previously graded as Gleason score 6 (3 + 3) are now considered as 7 (3 + 4).

Patients and methods

A matched-pair analysis was conducted. In all, 215 patients with Gleason score 6 or 7 (3 + 4) prostate cancer on biopsy who underwent RP before 31 December 2005 (pre-ISUP group), were matched 1:1 by biopsy Gleason score, clinical tumour category, PSA level, and margin status to patients undergoing RP between 1 January 2008 and 31 December 2011 (post-ISUP group). Patients were followed until BCR defined as a PSA level of ≥0.2 ng/mL. Risk of BCR was analysed in a competing-risk model.

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Results

The median follow-up was 9.5 years in the pre-ISUP group and 4.8 years in the post-ISUP group. The 5-year cumulative incidences of BCR were 34.0% and 13.9% in the pre-ISUP and post-ISUP groups, respectively (P < 0.001). The difference in cumulative incidence applied to both patients with Gleason score 6 (P < 0.001) and 7 (3 + 4) (P = 0.004). There was no difference in the 5-year cumulative incidence of BCR between patients with pre-ISUP Gleason score 6 and post-ISUP Gleason score 7 (3 + 4) (P = 0.34). In a multiple Cox-proportional hazard regression model, ISUP 2005 grading was a strong prognostic factor for BCR within 5 years of RP (hazard ratio 0.34; 95% confidence interval 0.22–0.54; P < 0.001).

Conclusion

The revision of the Gleason grading system has reduced the risk of BCR after RP in patients with biopsy Gleason score 6 and 7 (3 + 4). This may have consequences when comparing outcomes across studies and historical periods and may affect future treatment recommendations.

Video: Aquablation – image-guided robot-assisted waterjet ablation of the prostate

Aquablation – image-guided robot-assisted waterjet ablation of the prostate: initial clinical experiences

Peter Gilling, Rana Reuther, Arman Kahokehr and Mark Fraundorfer

 

Department of Urology, Tauranga Hospital, Tauranga, New Zealand

 

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Objective

To assess the safety and feasibility of aquablation in a first-in-man study. Aquablation is a novel minimally invasive water ablation therapy combining image guidance and robotics (aquabeam®) for the targeted and heat-free removal of prostatic tissue in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Patients and Methods

A prospective, non-randomised, single-centre trial in men aged 50–80 years with moderate-to-severe LUTS was conducted. Under real-time image-based ultrasonic guidance, aquabeam technology enables surgical planning and mapping, and leads to a controlled heat-free resection of the prostate using a high-velocity saline stream. Patients were evaluated at 1, 3, and 6 months after aquablation.

Results

In all, 15 patients were treated with aquablation under general anaesthesia. The mean (range) age was 73 (59–86) years and prostate size was 54 (27–85) mL. A substantial median lobe was present in six of the 15 patients. The mean International Prostate Symptom Score (IPSS) was 23 and the maximum urinary flow rate (Qmax) was 8.4 mL/s at baseline. The mean procedural time was 48 min with a mean aquablation treatment time of 8 min. All procedures were technically successful with no serious or unexpected adverse events (AEs). All but one patient had removal of catheter on day 1, and most of the patients were discharged on the first postoperative day. No patient required a blood transfusion, and postoperative sodium changes were negligible. There were no serious 30-day AEs. One patient underwent a second aquablation treatment within 90 days of the first procedure. The mean IPSS score statistically improved from 23.1 at baseline to 8.6 at 6 months (P < 0.001) and the Qmax increased from 8.6 mL/s at baseline to 18.6 mL/s at the 6-month follow-up (P < 0.001). At 6 months, the mean detrusor pressure at Qmax decreased to 45 cmH20 from 66 cmH20 at baseline (P < 0.05), and the mean prostate size was reduced to 36 mL, a 31% reduction in size vs baseline (P < 0.001). No cases of urinary incontinence or erectile dysfunction were reported.

Conclusions

These preliminary results from this initial study show aquablation of the prostate is technically feasible with a safety profile comparable to other BPH technologies. The combination of surgical mapping by the operating surgeon and the high-velocity saline provides a promising technique delivering a conformal, quantifiable, and standardised heat-free ablation of the prostate. Advantages of this technique include reduction in resection time compared with other endoscopic methods, as well as the potential to preserve sexual function.

 

Video: IFES to manage non-neuropathic UAB in children

Transcutaneous interferential electrical stimulation for the management of non-neuropathic underactive bladder in children: a randomised clinical trial

Abdol-Mohammad Kajbafzadeh, Lida Shari-Rad*, Seyedeh-Sanam Ladi-Seyedian and Sarah Mozafarpour

 

Department of Pediatric Urology, Pediatric Urology Research Center, and *Department of Physical Therapy, ChildrenHospital Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran

 

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Objectives

To assess the efficacy of transcutaneous interferential electrical stimulation (IFES) and urotherapy in the management of non-neuropathic underactive bladder (UAB) in children with voiding dysfunction.

Patients and Methods

In all, 36 children with UAB without neuropathic disease [15 boys, 21 girls; mean (sd) age 8.9 (2.6) years] were enrolled and then randomly allocated to two equal treatment groups comprising IFES and control groups. The control group underwent only standard urotherapy comprising diet, hydration, scheduled voiding, toilet training, and pelvic floor and abdominal muscles relaxation. Children in the IFES group likewise underwent standard urotherapy and also received IFES. Children in both groups underwent a 15-session treatment programme twice a week. A complete voiding and bowel habit diary was completed by parents before, after treatment, and 1 year later. Bladder ultrasound and uroflowmetry/electromyography were performed before, at the end of treatment course, and at the 1-year follow-up.

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Results

The mean (sd) number of voiding episodes before treatment was 2.6 (1) and 2.7 (0.76) times/day in the IFES and control groups, respectively, which significantly increased after IFES therapy in IFES group, compared with only standard urotherapy in the control group [6.3 (1.4) vs 4.7 (1.3) times/day, P < 0.002). The mean (sd) bladder capacity before treatment was 424 (123) and 463 (121) mL in the control and IFES groups, respectively, which decreased significantly at 1 year after treatment in the IFES group compared with the controls, at 227 (86) vs 344 (127) mL (P < 0.01). Maximum urine flow increased and voiding time decreased significantly in the IFES group compared with controls at the end of treatment sessions and 1 year later (P < 0.05). All the children had abnormal flow curves at the beginning of the study. The flow curve became normal in 14/18 (77%) of the children in the IFES group and six of 18 (33%) in the control group by the end of follow-up (P < 0.007). At the end of the treatment course, night-time wetting was improved in all children who had this symptom before the treatment in the IFES group (P < 0.01).

Conclusion

Combining IFES and urotherapy is a safe and effective therapy in the management of children with UAB.

Video: Some like it safe

Preoperative JJ stent placement in ureteric and renal stone treatment: results from the Clinical Research Office of Endourological Society (CROES) ureteroscopy (URS) Global Study

Dean Assimos, Alfonso Crisci*, Daniel Culkin, Wei Xue, Anita Roelofs§, Mordechai Duvdevani, Mahesh Desai** and Jean de la Rosette†† on behalf of the CROES URS Global Study Group

 

Department of Urology, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA, *Department of Urology, Careggi Hospital, Florence, Italy, Department of Urology, The University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA, Department of Urology, Renji Hospital, Shanghai, China, §Department of Urology, Rijnstate Hospital, Arnhem, The Netherlands, ††Department of Urology, AMC University Medical Centre, Amsterdam, The Netherlands, Department of Urology, Hadassah Ein-Kerem University Hospital, Jerusalem, Israel, and **Department of Urology, Muljibhai Patel Urological Hospital, Nadiad, India

 

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Objective

To compare outcomes of ureteric and renal stone treatment with ureteroscopy (URS) in patients with or without the placement of a preoperative JJ stent.

Patients and Methods

The Clinical Research Office of the Endourological Society (CROES) URS Global Study collected prospective data for 1 year on consecutive patients with ureteric or renal stones treated with URS at 114 centres around the world. Patients that had had preoperative JJ stent placement were compared with those that did not. Inverse-probability-weighted regression adjustment (IPWRA) was used to examine the effect of preoperative JJ stent placement on the stone-free rate (SFR), length of hospital stay (LOHS), operative duration, and complications (rate and severity).

Results

Of 8 189 patients with ureteric stones, there were 978 (11.9%) and 7 133 patients with and without a preoperative JJ stent, respectively. Of the 1 622 patients with renal stones, 590 (36.4%) had preoperative stenting and 1 002 did not. For renal stone treatment, preoperative stent placement increased the SFR and operative time, and there was a borderline significant decrease in intraoperative complications. For ureteric stone treatment, preoperative stent placement was associated with longer operative duration and decreased LOHS, but there was no difference in the SFR and complications. One major limitation of the study was that the reason for JJ stent placement was not identified preoperatively.

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Conclusions

The placement of a preoperative JJ stent increases SFRs and decreases complications in patients with renal stones but not in those with ureteric stones.

Video: Restoration not Replacement – Enclomiphene for Secondary Hypogonadism

Oral enclomiphene citrate raises testosterone and preserves sperm counts in obese hypogonadal men, unlike topical testosterone: restoration instead of replacement

Edward D. Kim, Andrew McCullough* and Jed Kaminetsky

 

University of Tennessee Graduate School of Medicine, Knoxville, TN
*Urological Institute of Northeastern, New York, NY, USA, and University Urology Associates, New York, NY, USA

 

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Objectives

To determine the effects of daily oral doses of enclomiphene citrate compared with topical testosterone gel treatment on serum total testosterone (TT), luteinising hormone (LH), follicle-stimulating hormone (FSH), and sperm counts in men with secondary hypogonadism.

Patients and Methods

Two parallel randomised, double-blind, double-dummy, placebo-controlled, multicentre, phase III studies were undertaken to evaluate two doses of enclomiphene citrate vs testosterone gel (AndroGel®1.62%) on TT, LH, FSH, and sperm counts in overweight men aged 18–60 years with secondary hypogonadism. Men were screened and enrolled in the trials (ZA-304 and ZA-305). All enrolled men had early morning serum TT levels in the low or low normal range (≤300 ng/dL; ≤10.4 nmol/L) and had low or normal LH (<9.4 IU/L) levels measured on two separate occasions 2–10 days apart. Serum samples were obtained over the course of the study to determine relevant hormone levels at baseline and after 16 weeks of treatment. Men provided semen samples twice to enroll at the beginning and twice at the end of the study.

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Results

TT levels increased between baseline and after 16 weeks of treatment in all the treatment groups. FSH and LH levels increased in the enclomiphene citrate groups and decreased in the testosterone gel group at 16 weeks. Enclomiphene citrate maintained sperm concentration in the normal range over the treatment period, while there was a marked reduction in spermatogenesis in the testosterone gel group.

Conclusions

Enclomiphene citrate consistently increased serum TT, LH and FSH, restoring normal levels of serum TT. Enclomiphene citrate treatment maintained sperm concentrations in the normal range. The effects on TT were also seen with testosterone replacement via testosterone gel but sperm counts were not maintained.

Video: Be Clear on Cancer – Blood in Pee

Assessing the impact of mass media public health campaigns. ‘Be Clear on Cancer: Blood in Pee’ a case in point

Archie Hughes-Hallett*, Daisy Browne, Elsie Mensah*, Justin Vale*† and Erik Mayer*†‡

 

*Department of Surgery and Cancer, Imperial College London, Department of Urology, Imperial College Healthcare Trust, and Institute of Global Health Innovation, Imperial College London, London, UK

 

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Objectives

To assess the impact on suspected cancer referral burden and new cancer diagnosis of Public Health England’s recent Be Clear on Cancer ‘blood in pee’ mass media campaign.

Methods

A retrospective cohort study design was used. For two distinct time periods, August 2012 to May 2013 and August 2013 to May 2014, all referrals of patients deemed to be at risk of urological cancer by the referring primary healthcare physician to Imperial College NHS Healthcare Trust were screened. Data were collected on age and sex and whether the referral was for visible haematuria, non-visible haematuria or other suspected urological cancer. In addition to referral data, hospital episode data for all new renal cell (RCC) and upper and lower tract transitional cell carcinoma (TCC), as well as testicular and prostate cancer diagnoses for the same time periods were obtained.

Results

Over the campaign period and the subsequent 3 months, the number of haematuria referrals increased by 92% (P = 0.013) when compared with the same period a year earlier. This increase in referrals was not associated with a significant corresponding rise in cancer diagnosis; instead changes of 26.8% (P = 0.56) and −3.3% (P = 0.84) were seen in RCC and TCC, respectively.

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Conclusions

This study has shown that the Be Clear on Cancer ‘blood in pee’ mass media campaign significantly increased the number of new suspected cancer referrals, but there was no significant change in the diagnosis of target cancers across a large catchment. Mass media campaigns are expensive, require significant planning and appropriate implementation and, while the findings of this study do not challenge their fundamental objective, more work needs to be done to understand why no significant change in target cancers was observed. Further consideration should also be given to the increased referral burden that results from these campaigns, such that pre-emptive strategies, including educational and process mapping, across primary and secondary care can be implemented.

Video: Improving Prostate Cancer Risk Assessment Using The PHI

Improving Multivariable Prostate Cancer Risk Assessment Using The Prostate Health Index

Robert W. Foley*, Laura Gorman*, Neda Shari, Keefe Murphy§, Helen MooreAlexandra V. Tuzova**, Antoinette S. Perry**, T. Brendan Murphy§, Dara J. Lundon*†† and R. William G. Watson*

 

*Conway Institute of Biomolecular and Biomedical Research, University College Dublin, UCD School of Medicine and Medical Science, University College Dublin, Department of Biochemistry, Beaumont Hospital, §UCD School of Mathematical Sciences, University College Dublin, Insight Centre for Data Analytics, University College Dublin, **Prostate Molecular Oncology, Institute of Molecular Medicine, Trinity College Dublin, and ††Department of Urology, Mater Misericordiae University Hospital, Dublin, Ireland

 

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Objectives

To analyse the clinical utility of a prediction model incorporating both clinical information and a novel biomarker, p2PSA, in order to inform the decision for prostate biopsy in an Irish cohort of men referred for prostate cancer assessment.

Patients and Methods

Serum isolated from 250 men from three tertiary referral centres with pre-biopsy blood draws was analysed for total prostate-specific antigen (PSA), free PSA (fPSA) and p2PSA. From this, the Prostate Health Index (PHI) score was calculated (PHI = (p2PSA/fPSA)*√tPSA). The men’s clinical information was used to derive their risk according to the Prostate Cancer Prevention Trial (PCPT) risk model. Two clinical prediction models were created via multivariable regression consisting of age, family history, abnormality on digital rectal examination, previous negative biopsy and either PSA or PHI score, respectively. Calibration plots, receiver-operating characteristic (ROC) curves and decision curves were generated to assess the performance of the three models.

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Results

The PSA model and PHI model were both well calibrated in this cohort, with the PHI model showing the best correlation between predicted probabilities and actual outcome. The areas under the ROC curve for the PHI model, PSA model and PCPT model were 0.77, 0.71 and 0.69, respectively, for the prediction of prostate cancer (PCa) and 0.79, 0.72 and 0.72, respectively, for the prediction of high grade PCa. Decision-curve analysis showed a superior net benefit of the PHI model over both the PSA model and the PCPT risk model in the diagnosis of PCa and high grade PCa over the entire range of risk probabilities.

Conclusion

A logical and standardized approach to the use of clinical risk factors can allow more accurate risk stratification of men under investigation for PCa. The measurement of p2PSA and the integration of this biomarker into a clinical prediction model can further increase the accuracy of risk stratification, helping to better inform the decision for prostate biopsy in a referral population.

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