Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Urinary Bladder Neck Obstruction

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Urethral Obstruction

Urethral Diseases

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Patients with low-risk prostate cancer who were elected for active surveillance protocol will have only medical treatment for control of their lower urinary tract symptoms secondary to bladder outlet obstruction

Patients with low-risk prostate cancer who were elected for active surveillance protocol will be offered anatomical endoscopic enucleation of the prostate for control of their lower urinary tract symptoms secondary to bladder outlet obstruction

Transurethral endoscopic enucleation of the prostate adenoma

Anatomical Endoscpic enucleation of the Prostate

Ahmed Elshal, MD

We will compare oncological and functional outcomes of anatomical endoscopic enucleation of the prostate (AEEP) versus continued medical treatment in low-risk prostate cancer patients for whom an active surveillance protocol was selected.

Prostate cancer is the most common cancer in men; in 2018 1,276,106 new cases of prostate cancer were reported worldwide (1).

The diagnosis of prostate cancer is based on the microscopic evaluation of prostate tissue obtained via needle biopsy.

The International Society of Urological Pathology (ISUP) Consensus system assigns new Grade Groups from 1 to 5, derived from the Gleason score (2).

Clinicians have stratified the diagnosis into low, intermediate, and high-risk disease based on the sum of Gleason patterns, prostate specific antigen (PSA) level, and clinical stage (3).

Recently The National Comprehensive Cancer Network risk stratification uses a 5-tier system by adding very low- and very high- as a subdivision of the low- and high-risk groups (4).

Men diagnosed with localized disease (defined as no regional lymph nodes or distant metastases) have 3 primary options: expectant management, surgery and radiation.

Expectant management (monitoring for prostate cancer progression while not undergoing definitive therapy) consists of watchful waiting and active surveillance (5).

According to The Prostate Testing for Cancer and Treatment (ProtecT) trial which randomized 1643 localized prostate cancer men to active monitoring, surgery, or radiation. At 120 months, ProtecT found that 1.5% of patients on active monitoring died from prostate cancer, which did not differ significantly from the 0.9% after surgery or the 0.7% after radiation (6).

The use of active surveillance (AS) for men with low-risk prostate cancer (PCa) is well established, although the criteria for admission to a protocol vary according to the institution. (7-9) Men with significantly enlarged prostates (\>100 g) may be assigned a high-risk category when their prostate-specific antigen (PSA) rises above 10 ng/ml, although there is evidence AS is safe in this population. (10) In the presence of lower urinary tract symptoms (LUTS), men with significantly enlarged prostates often undergo radical prostatectomy (RP) to treat PCa and coexisting LUTS. This approach, which prioritizes oncologic control, may increase surgical morbidity for patients who otherwise might continue AS after an outlet procedure to address their LUTS.

The use of holmium laser enucleation of the prostate (HoLEP) for the management of LUTS in men with significantly enlarged prostates and coexisting low-risk PCa has not been prospectively studied. HoLEP has proven to be a safe and effective treatment for men with LUTS. (11) Incidental detection of malignancy at the time of HoLEP ranges from 5% to 13% in men without a prior diagnosis of PCa, and there is evidence PSA has improved sensitivity for cancer progression in the post-HoLEP setting. (12-15) The management of T1a-b PCa incidentally discovered after transurethral resection of prostate (TURP) has been well documented with AS recommended for most patients. (16-18) However, the management of men with known low-risk PCa, clinically significant LUTS, and significantly enlarged prostates remains underexplored.

Herein, we prospectively assess patients with low-risk PCa on AS who underwent AEEP for clinically significant LUTS and enlarged prostate gland size.

Our study focuses on functional and oncologic outcomes.

Transurethral Prostate Enucleation in Surveillance Protocol for Low Risk Prostate Cancer

Anatomical Endoscopic Enucleation of the Prostate for Treatment of Bladder Outlet Obstruction in Patients With Low-risk Prostate Cancer on Surveillance Protocol, Prospective Assessment of Functional and Oncological Outcome

changes of PSA level from baseline to one year follow up following active treatment

cancer progression as depicted by multiparametric MRI

improvement of urine flow parameters as depicted by peak flow rate (ml/sec)

improvement of urinary symptoms as depicted by symptom score (International prostate symptom score)

PSA, Radiological and grade progression whenever biopsy is indicated

Mansoura University

A. Professor of Urology

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

PAE performed under local anesthesia using officially approved microspheres.

PAE is performed under local anesthesia using commercially available and approved microspheres (study is not limited to a specific manufacturer or product).

Prostatic Artery Embolization

Dominik Abt, MD

Gautier Müllhaupt, MD

This is a pilot study assessing efficacy and safety in patients with advanced prostate cancer.

PAE has been shown to be safe and effective in the treatment of prostatic bleeding and lower urinary tract symptoms arising from bladder outlet obstruction.

Advanced (defined as locally advanced, metastatic or both in this study) PCA is frequently associated with both of these conditions. The currently most frequently performed palliative surgical treatment is TURP. Though performed endoscopically, TURP is associated with significant side effects in this setting. PAE has been shown to have a superior side-effect profile in the treatment of bladder outlet obstruction compared to TURP.

In addition, there is growing evidence that patients with advanced PCA might benefit from cytoreductive therapy (e.g. radical prostatectomy or external beam radiation therapy). However, recent methods of cytoreductive treatment of PCA hold the risk of being highly invasive and are associated with severe side effects. PAE might represent a minimally invasive alternative in this setting.

Therefore, efficacy and safety of PAE in patients with advanced prostate cancer is assessed in this pilot-study.

Prostatic Artery Embolization in Advanced Prostate Cancer

Prostatic Artery Embolization (PAE) in Patients With Advanced Prostate Cancer: A Pilot Study.

Decision will be made individually up on request and based on approval by our local ethics committee.

Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))

Assessment of occurrence of hematuria according to CTCAE v.4.03 classification

Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))

Measurement of urinary stream (mL/s) by urinary flow rate measurement

Measurement of post void residual urine (mL) by transabdominal ultrasound

Assessment of number and type of reinterventions for prostate and bladder problems

Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE

Possibility of successful completion of PAE in the study cohort defined by compete stasis of blood flow in the prostate

Change of tumor volume calculated by magnetic resonance imaging

Change of prostate volume calculated by magnetic resonance imaging

Dominik Abt

Dr. med.

Symptoms and General Pathology

Urinary Bladder Neoplasms

Urolithiasis

Urinary Calculi

Members of healthcare teams involved in the delivery of day-case endourology operations.

These are qualitative interviews and involve no intervention

None - qualitative interviews

Joseph B John, BSc, MBBS

John S McGrath, MBBS, MD

A qualitative research study conducted in hospitals across England, in which staff members will be interviewed. We will interview staff who are directly or indirectly involved in delivering care for patients undergoing the operations of interest; namely bladder tumour resection, prostate resection or enucleation, and ureteroscopy for upper urinary tract stones. We hope to find out the reasons why some hospitals can perform day-case surgery with very high rates, and why others do not. We also hope to find out about any unexpected outcomes observed when performing day-case surgery for the operations of interest.

Staff working in a range of different hospitals from across England with varying day-case rates will be interviewed. Hospitals in large city and more rural areas will be assessed. Interviews are anticipated to take place over a six month period. The study will end when "saturation" is achieved, whereby no new themes are identified through interviews. Saturation will be sought for each individual operation of interest.

Safe day-case surgery pathways offer to reduce pressure on hospitals by avoiding overnight inpatient admission. This is particularly relevant given the intense pressures on hospital resources in the United Kingdom. Urological surgery includes a number of frequently performed operations for which safe day-case surgery pathways have been demonstrated. These include bladder tumour resection (TURBT), prostate resection or enucleation using diathermy or laser (TURP and TUEP), and ureteroscopy and laser for upper urinary tract stones (URS). All of these operation types involve endoscopic access to the bladder via the urethra, and do not involve skin incisions. They can be performed under general or spinal anaesthesia, although spinal anaesthesia is rarely used for ureteroscopy.

For the 12 months from December 2021, the national median day-case rate for transurethral resection of bladder tumour In England was 21.1%, and ranged from 0% to 87.3% at different hospitals, with an interquartile range (IQR) of 10.5% to 37.7%, and 23,071 cases performed in total. For bladder outflow obstruction surgery the median day-case rate was 7.7% (range 0% to 82.4%, IQR 4.4% to 19.1%, 18,912 cases), and this includes TURP and TUEP. For URS the median day case rate was 60.1% (range 0% to 87.9%, IQR 44.4% to 69.7%, 23,130 cases). This demonstrates that for these common operations there is significant variation in practice across England.

The Getting It Right First Time (GIRFT) Urology programme advocates for a "day-case by default" approach to TURBT and URS, and that day-case surgery should ideally be offered for prostate resection and enucleation. As well as reducing pressure on inpatient services, greater day-case adoption offers to reduce financial costs, shorten waiting lists by allowing greater access to day-case theatres away from the acute hospital, and reduce environmental impact by adopting a less resource-intensive approach. It also offers a more standardised patient experience.

National day-case rates for all of TURBT, TURP/TUEP and URS have increased over the past five years, however the wide variation in practice identifies a need to understand reasons underlying a significant observed divergence in practice. We want to understand why some hospitals have rapidly adopted day-case surgery whereas others have not. Furthermore, it is necessary to understand any positive and negative outcomes associated with the increased utilisation of day-case surgery. In order to explore this area we intend to perform qualitative research involving members of staff involved in the delivery of one or more of the operations of interest. We will interview staff from a range of different hospitals with differing day-case performances to further understand enablers and barriers associated with day-case adoption. We would also like to understand staff members' experiences of any wider unexpected outcomes associated with day-case surgery adoption.

Day-case Endourology; Enablers, Barriers, Unexpected Outcomes

Understanding Enablers, Barriers, and Unexpected Outcomes Associated With Adoption of Routine Day-case Surgery Pathways for Common Endourology Operations: Qualitative Interviews With Healthcare Professionals.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transurethral Prostate Enucleation in Surveillance Protocol for Low Risk Prostate Cancer	NCT05631080	Prostate Cancer... Bladder Outlet ...	Anatomical Endo...	18 Years -	Mansoura University
Prostatic Artery Embolization in Advanced Prostate Cancer	NCT03457805	Prostate Cancer Bladder Outlet ...	Prostatic Arter...	-	Cantonal Hospital of St. Gallen
Prostatic Artery Embolization in Advanced Prostate Cancer	NCT03457805	Prostate Cancer Bladder Outlet ...	Prostatic Arter...	-	Cantonal Hospital of St. Gallen
Transurethral Prostate Enucleation in Surveillance Protocol for Low Risk Prostate Cancer	NCT05631080	Prostate Cancer... Bladder Outlet ...	Anatomical Endo...	18 Years -	Mansoura University
Day-case Endourology; Enablers, Barriers, Unexpected Outcomes	NCT06152666	Bladder Cancer Bladder Outlet ... Urolithiasis	None - qualitat...	-	Royal Devon and Exeter NHS Foundation Trust

Spots Global Cancer Trial Database for bladder outlet obstruction