Bladder Outlet Obstruction Clinical Trial
Official title:
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
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03457805 -
Prostatic Artery Embolization in Advanced Prostate Cancer
|
N/A | |
Completed |
NCT00507455 -
Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction
|
Phase 2 | |
Recruiting |
NCT04626167 -
Concomitant Renal and Urinary Bladder Allograft Transplantation
|
Early Phase 1 | |
Not yet recruiting |
NCT06422312 -
A Study Comparing a Disposable Flexible Cystoscope With Reusable Scopes in Adult Patients.
|
N/A | |
Suspended |
NCT01779349 -
Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"
|
N/A | |
Not yet recruiting |
NCT01388348 -
Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study
|
N/A | |
Completed |
NCT00710749 -
The Value of Multiple Urine Flow Rate Measurements in Male Benign Prostatic Hyperplasia (BPH) Subjects
|
N/A | |
Recruiting |
NCT03486639 -
Urodynamics and Clinical Factors That Are Associated With Bladder Over-sensitivity
|
||
Enrolling by invitation |
NCT02869061 -
Effectiveness and Safety of Adipose-derived Regenerative Cells for Reduction of Risk of Bladder Neck Contracture
|
Phase 1/Phase 2 | |
Completed |
NCT02031653 -
Comparison Between Invasive Pressure Flow Study and Non-invasive Penile Cuff Test
|
||
Completed |
NCT00605319 -
An Open Label Study to Measure Efficacy of Fesoterodine (Toviaz) Post Surgery for Benign Prostatic Hyperplasia
|
Phase 4 | |
Recruiting |
NCT03503721 -
Bipolar Transurethral Enucleation (BipolEP) vs Bipolar Transurethral Resection of the Prostate
|
N/A | |
Not yet recruiting |
NCT05910983 -
Prostate Enucleation With Intravesical Botox Injections in Treating BPH and Bladder Overactivity
|
N/A | |
Recruiting |
NCT03281798 -
Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction
|
N/A | |
Completed |
NCT05470751 -
GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology
|
||
Completed |
NCT04981080 -
DU and BOO in Women With and Without Symptoms of VD
|
||
Completed |
NCT00410514 -
A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
|
Phase 2 | |
Recruiting |
NCT06152666 -
Day-case Endourology; Enablers, Barriers, Unexpected Outcomes
|
||
Not yet recruiting |
NCT04514718 -
Low Energy HoLEP on IPSS
|
N/A | |
Completed |
NCT01661621 -
Antimuscarinics as the First-line Treatment for Male With IPSS-V/S≤1
|
Phase 4 |