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Year : 2020  |  Volume : 12  |  Issue : 5  |  Page : 30-34  

Abstract - SUA202 (Oncology)

Date of Web Publication9-Jun-2020

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DOI: 10.4103/0974-7796.286037

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How to cite this article:
. Abstract - SUA202 (Oncology). Urol Ann 2020;12, Suppl S1:30-4

How to cite this URL:
. Abstract - SUA202 (Oncology). Urol Ann [serial online] 2020 [cited 2021 Sep 21];12, Suppl S1:30-4. Available from: https://www.urologyannals.com/text.asp?2020/12/5/30/286037

   Phase 3 study of androgen deprivation therapy with enzalutamide or placebo in metastatic hormone-sensitive prostate cancer: The ARCHES trial Top

Andrew J. Armstrong, Russell Z. Szmulewitz1, Daniel Petrylak2, Arnauld Villers3, Arun Azad4, Antonio Alcaraz5, Boris Alekseev6, Taro Iguchi7, Neal D. Shore8, Brad Rosbrook9, Jennifer Sugg10, Benoit Baron11, Lucy Chen10, Arnulf Stenzl12

Duke Cancer Institute Center for Prostate and Urologic Cancers, Durham, NC,1The University of Chicago, Chicago, IL,2Yale Cancer Center, New Haven, CT,8Carolina Urologic Research Center, Myrtle Beach, SC,9Pfizer Inc., San Diego, CA,10Astellas Pharma Inc., Northbrook, IL, USA,3Department of Urology, University Hospital Centre, Lille University, Lille, France,4Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia,5Hospital Clinic de Barcelona, Barcelona, Spain,6Hertzen Moscow Cancer Research Institute, Moscow, Russia,7Osaka City University Graduate School of Medicine, Osaka, Japan,11Astellas Pharma Inc, Leiden, The Netherlands,12Department of Urology, University Hospital, Eberhard Karls University, Tübingen, Germany

E-mail: [email protected]

Background: ENZA has demonstrated benefit in men with metastatic and nonmetastatic castration-resistant prostate cancer (CRPC).

Methods: ARCHES is a multinational, double-blind, Phase 3 study (NCT02677896). Patients with mHSPC were randomized 1:1 to ENZA (160 mg/day)+ADT or PBO+ADT, stratified by disease volume (CHAARTED criteria) and prior docetaxel. Primary endpoint was radiographic progression-free survival (rPFS) assessed centrally or death within 24 weeks of treatment discontinuation. Secondary endpoints included time to prostate-specific antigen (PSA) progression, PSA and radiographic responses, and overall survival (OS). Treatment continued until disease progression or unacceptable toxicity.

Results: 1150 men were randomized to ENZA (n=574) or PBO (n=576); baseline characteristics were balanced between groups. Overall, 67% had distant metastasis at initial diagnosis; 63% had high-volume disease; 18% had prior docetaxel. Median follow-up was 14.4 months. ENZA+ADT significantly improved rPFS [Table 1]; significant improvements in rPFS were reported in prespecified subgroups of disease volume, pattern of spread, region, and prior docetaxel (hazard ratios [HRs] 0.25-0.52). Secondary endpoints improved with ENZA+ADT [Table 1]; OS data are immature. Grade 3-4 adverse events (AEs) were reported in 23.6% of ENZA patients versus 24.7% of PBO patients with no unexpected AEs.

Conclusions: ENZA+ADT significantly improved rPFS and other endpoints versus PBO+ADT in mHSPC, with a safety analysis that appears consistent with the safety profile of ENZA in previous CRPC trials.

Acknowledgments: Medical writing and editorial assistance was provided by Stephanie Rippon, MBio, Folabomi Oladosu, PhD, and Jane Beck from Complete HealthVizion, funded by the study sponsors.

Financial support and sponsorship: This study was funded by Astellas Pharma Inc. and Pfizer Inc., the co-developers of enzalutamide. This abstract was originally presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium 2019 (ASCO-GU 2019). The data in this abstract are published in the following manuscript: Armstrong AJ, et al. J Clin Oncol 2019;37:2974-86.

   A genomics approach to male infertility Top

Naif Alhatha, Sateesh Maddirevula1, Serdar Coskun2, Hamed Alali, Mirna Assoum3, Thomas Morris2,Shaheed Alsuhaibani, Abdulmalik Mirdawi, Hesham Adel Deek, Niema Ibrahim1, Firdous Abdulwahab1, Waleed Altaweel, Majed J Dasouki1,2, Abdullah Assiri3, Wafa Qabbaj2, Fowzan S Alkuraya1,4

Departments of Urology,1Genetics and3Comparative Medicine, King Faisal Specialist Hospital and Research Center,2Department of Pathology and Laboratory Medicine, King Faisal Specialist Hospital and Research Center and College of Medicine, Alfaisal University,4Department of Anatomy and Cell Biology, College of Medicine, Alfaisal University, Riyadh, Saudi Arabia

E-mail: [email protected]

Background: Male infertility is a relatively common condition that remains poorly understood at the molecular level in humans.

Purpose: To investigate the yield of a “genomics-first” approach to male infertility.

Methods: Patients with severe oligospermia and non-obstructive azoospermia were investigated using whole-exome sequencing (WES) in parallel with the standard practice of chromosomal analysis including Y chromosome microdeletion (YCM).

Results: In a relatively large cohort (n=285) of patients, we found that while 9.82%% had evidence of chromosomal aberrations, nearly a fifth (n=61; 21.4%) had a potential monogenic form of male infertility. These monogenic forms ranged from the confirmed i.e. in genes previously reported to cause male infertility with or without other phenotypes in humans (n=16; 5.6%) to the tentative i.e. in novel candidate genes first reported in this study (n=38; 13.3%). While all 35 candidate genes have substantial biological links to male germ cell development especially from the corresponding mouse knockouts, a few of these candidate genes (TERB1 (CCDC79), ZSWIM7, MAGEE2) were found to be independently mutated in unrelated patients in our cohort, which lends further support to their candidacy. Surprisingly, our cohort also revealed that male infertility can be the sole phenotypic expression of a number of genes that are known to cause multisystemic manifestations in humans (n=7; 2.5%), thus highlighting the power of a genomic-first approach, since these genes are unlikely to be selected for targeted sequencing in patients with isolated male infertility.

Conclusion: Our study greatly expands the morbid genome of male infertility and identifies major gaps in the standard approach, which overlooks the significant contribution of monogenic causes to this important clinical entity.

   Dose urethral injury during penile prosthesis insertion mandate procedure abortion? Top

S. AlSuhaibani, H. Alali, E. Gutub, R. Seyam, M. S. Kattan, N. Al Hathal, S. Kattan

Department of Urology, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia

E-mail: [email protected]

Introduction: Urethral injury sometimes occurs during penile prosthesis revision surgery leading to aborting the procedure. We are sharing our experience in synchronous urethral repair and penile prosthesis insertion.

Methods: We retrospectively reviewed our cases with primary urethral repair and prosthesis implantation. We assessed the clinical outcome of the combined procedure regarding the incidence of implant infection, poor flow, and new-onset lower urinary tract symptoms. Cases with any complication were destined for further investigations with uroflow, urine culture, and ascending urethrogram.

Results: We found seven cases that underwent a synchronous urethral repair with penile prosthesis insertion. The mean age was 60.8 years (46-70). Three out of seven patients were diabetic (43%), and one has neurogenic bladder due to spina bifida (14%). Four out of seven patients were revision cases (57%). All cases were complicated with fibrosis causing difficult dilation. The type of urethral injury was a ventral urethral injury during corporal dissection in 5 cases (71%), and corpora urethral perforation in 2 cases (29%). Our decision to proceed with prosthesis insertion was based on the difficulty of re-dilating the corpora in the future. The implanted prosthesis types were malleable prosthesis in 6 cases (86%) and 3-pieces inflatable prosthesis in one case (14%).

All patients were followed up post operatively with mean follow up time 21.7 months, all patients had successful synchronous urethral repair with the absence of lower urinary symptoms, prosthesis infection, or need for reversion or removal. All devices were functioning well, and the patients had good subjective urinary flow. No patient required further investigations for urethral complications.

Conclusion: Synchronous urethral repair with a successful insertion of a penile prosthesis can be done safely with a satisfactory outcome.

   Micro-dissection testicular sperm extraction in Klinefelter's syndrome patients, King Faisal Specialist Hospital and Research Centre, Riyadh experience Top

A. Almardawi, S. Kattan, N. Alhathal, S. AlSuhaibani, H. Alali, E. Gutub, R. Akram, Y. Kattan

Department of Urology, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia

E-mail: [email protected]

Introduction: In Klinefelter's syndrome patients with azoospermia, microscopic testicular sperm extraction (m-TESE) can be proposed as a therapeutic option.

Aim of Study: To assess sperm retrieval rate in patients with Klinefelter's syndrome in King Faisal Specialist Hospital , Riyadh.

Methods: Retrospective, Chart review of 32 patients with Klinefelter's syndrome who underwent m-TESE were reviewed and analyzed. All patients had two sets of semen analysis after 3-5 days abstinence of ejaculation with further study of semen by in vitro fertilization (IVF) wash. Hormonal analysis was studied. Ultrasonography of testes was assessed pre-operatively. Testicular tubules were sent to IVF lab and were studied under the microscope looking for sperms. Some testicular tissues were sent for histopathology diagnosis.

Results: Patients' mean age was 34.9±6.0 years. Mean hormonal levels of E2, FSH, LH, prolactin, and testosterone were 96.0±22.0 pmol/L, 29.8±5.4 IU/L, 19.0±2.9 IU/L, 15.4±3.6 ug/L and 10.0±1.9 nmol/L, respectively. There were two mosaic Klinefelter's syndrome patients (6.25%), while 30 patients had a non-mosaic form (93.75%). The overall sperm retrieval rate was 37.5%. All patients had small bilateral testes. Sperm retrieval was successful in three patients with low spermatogenesis sperm retrieval, one patient with maturation arrest patient, and 8 patients with Sertoli-cell-only pattern. Four patients with complete hyalinization of testicular tissues had complete failure to retrieve sperms. Pregnancy rate after intra-cytoplasmic sperm injection was 50%.

Conclusion: Sperm retrieval rate in Klinefelter's syndrome patients with m-TESE is in accordance with most of those reported in the literature. Regarding histopathology, hypo-spermatogenesis showed favorable outcome. Pregnancy rate with intra-cytoplasmic sperm injection was 50%.

   Risk and impact of bacterial colonization of noninfected penile prosthesis Top

M. S. Kattan, S. Alsuhaibani, H. Alali, R. Seyam, A. Almardawi, N. Alhathal, S. Kattan

Department of Urology, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia

E-mail: [email protected]

Introduction: The risk of colonization of penile prosthesis without clinical infection was reported to be up to 50%. The implication of that finding on future penile prosthesis implantation is not well- defined.

Objectives: This study is designed to determine the incidence of bacterial colonization of penile prosthesis in patients presenting with malfunctioning penile prosthesis or dissatisfaction without evidence of clinical infection and determine it's impact on future prosthesis insertion.

Materials and Methods: A prospective study was conducted on 37 patients with previous history of penile prosthesis insertion who underwent penile prosthesis exchange either due to mechanical failure or dissatisfaction between 2014 and 2019. Intra-operative culture was obtained from extracted penile prosthesis. The time lapse between insertion and presentation was 2 to 9 years, mean 4.5 years. 83% of patients were diabetics, 13% had renal insufficiency. 13% had no risk factor for infection. Type of implanted prosthesis were Ambicore 32%, malleable 37%, AMS 700 26%, and Titan 8%.

Results: Upon reviewing our data, out of the 37 exchange, microbiological culture was positive in 12 patients, The incidence of colonization was 32.4%. The most common organism was coagulase negative staphylococci 81.8%. Escherichia coli 9%. 28 patients had immediate re-insertion of penile prosthesis. No evi- dence of prosthesis infection was noted in any of those patients.

Conclusion: Colonization of penile prosthesis is not uncommon but maybe less than previously reported. according to our study it does not seem to increase the risk of infection in future insertion of penile prosthesis.

   Outcomes for different nonsurgical management options of Peyronie's disease: Case series Top

Hossam S. El-Tholoth, Abdalmaged U. Althobity, Musa Alnumi, Amr Jad

Department of Urology, Prince Sultan Military Medical City, Riyadh, Saudi Arabia

E-mail: [email protected]

Purpose: Peyronie's disease is a fibrotic disorder of the penis characterized by formation of plaques on the tunica albuginea which managed with surgical and non-surgical approaches but till now still no standardized treatment plan available.

The aim is to assess the outcomes of different non-surgical approaches for the management of Peyronie's Disease in our institution.

Methods: A retrospective review of all patients with Peyronie's Disease who presented from 2013 to 2018 was performed. Demographic data were collected, the way of non-surgical management and the outcomes were reviewed. We excluded patients with incomplete data or lost follow up.

Results: We included 39 patients with a mean age of 52.5 years (Range 40-65). Twenty-nine patients were diabetic .the main compliant was a plaque in 10 pain in 4 penile deviation in 10, erectile dysfunction in five and mixed in 10 patients. Most of the patients (28) received oral medication in the form of (Pentoxifylline 400 mg BID, Tocopherol 200 IU OD, Anti-inflammatory, Tadalafil 5 mg daily) with penile remolding and vacuum use. 10 of them feel better in pain and plaque size and deviation degree. Ten received verapamil intralesional injection only one reported pain improvement and one showed better in penile angulation. Intralesional collagenase injection was used in 9 patients with dorsal plaque eight of them showed improvement in angulation degree and 4 plaque disappeared regarding the complications were mild post-injection pain, penile and suprapubic discoloration only one patient developed penile hematoma and surgical evacuation was needed.

Conclusions: Combined Oral medication, penile remolding, and vacuum use showed good outcomes and needed to be tried first. Despite the best non-surgical outcome was seen with Intralesional collagenase injection it is limited for the dorsal plaque and carries some risks and the patient should be well counseled for all management options.

   Efficacy of follicle-stimulating hormone as a treatment of severe idiopathic oligospermia: A retrospective study Top

A. Aljuhayman, A. Almardawi, H. Alali, S. AlSuhaibani, E. Gutub, S. Kattan, N. Alhathal

Department of Urology, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia

E-mail: [email protected]

Introduction: About 15% of couples are infertile, with the male factor being responsible for about 50% of these cases of infertility. Idiopathic Oligospermia (IO) is a dilemma that faces every Adnrologist and yet is one of the most common causes of male infertility. Although studies have shed some light on multiple treatment modalities and their effectiveness, one of the most fascinating ones is Follicle-stimulating hormone (FSH).

Methods: This is a single tertiary center retrospective study, all patients with severe IO ( sperm count of less than 5 million/ml ) from January 2016 till January 2018 were included in the study. We divided our retrospective population into 2 groups, Group 1 who received FSH 75 IU (Menogon) twice a week, and Group 2 who received FSH 150 IU (Menogon) twice a week. Semen parameters recorded pre-treatment and post-treatment.

Results: Number of the patients included in the study was 32. Group 1 included 16 patients who received FSH 75 IU. Group 2 included 16 patients who received FSH 150 IU. After 4 months of treatment, the mean sperm count in Group 1 increased to 4.745 million/ml (was 1.235 million/ml), while in Group 2 it increased to 1.516 million/ml (was 0.578 million/ml). The mean total motility in Group 1 was 20.3%, while Group 2 mean total motility was 27.5%.

Conclusion: In conclusion, our study elicited that a dose of FSH as low as 75 IU can improve sperm count significantly in patients with severe idiopathic oligospermia.

   The yield of microscopic varicocelectomy in men with severe oligospermia Top

A. Addar, S. Kattan, N. Alhathal, H. Alali, S. AlSuhaibani, E. Gutub, A. Almardawi

Department of Urology, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia

E-mail: [email protected]

Introduction: Varicocele is the cause of 35%-50% of men with primary infertility and up to 81% with secondary infertility. Various studies have shown that varicocele is related to testicular hypotrophy, impaired spermatogenesis. The effect of varicocelectomy in mild to moderate male factor infertility is well reported, however, we are studying the impact of varicocelectomy in sever oligospermia (<5 million).

Methods: We did a retrospective chart review study of all patients with severe oligospermia (sperm count less than 5 million) We looked into pre-op testosterone, LH, FSH, Prolactin, and TSH as predictive values for the outcome. We compared the pre-op and post-op semenalysis. Chi-square was used to compare the pre-op and post-op sperm count, motility and volume.

Results: 45 patients were included in the study. Mean age was 33.2-year-old, mean TSH, LH, FSH, Prolactin and testosterone were 2.63 mU/L, 6.96 IU/L, 8.68 IU/L, 11.2 ug/L and 14.53 nmol/L respectively. pre-op means of sperm count improved from 1.31M to 5.23M post op (6 months follow up). 4 out of 45 patients (0.9%) became azoospermic. two of them had ejaculate sperm in long term follow up.

Conclusion: The magnitude of improvement after microsurgical varicocelectomy for severely oligospermic patients is less profound than reported in mild male factor infertility. Future studies are needed on larger scale to include also impact on IVF results. Also we advice to cryopreseve sperm prior to varicocelectomy in patiens with cryptospermia or count less than 100,000 sperm/mL. However, this finding makes patients consultation is vital in severely oligospermic patients with regard to varicocele repair vs ART.

   Patient with duplex ureter injury underwent robot assisted laparoscopic common sheath ureteral reimplantation single docking: Case report Top

Suhail A. Kalantan, Maher S. Moazin, Naif A. Aldhaam, Saud A. Almousa

E-mail: [email protected]

Ureteral injury is common complication that need comprehensive understanding of ureteral injury management from minimal invasive intervention to ureteral reimplant in both early and late presentation. However, ureteral injury in duplex system rarely reported in literature. Here we are sharing our techniques and challenging in a patient who had a duplex ureteral injury with late presentation underwent robot assisted ureteral reimplantation.


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