Clinical trial NCT05631080: Transurethral Prostate Enucleation in Surveillance Protocol for Low Risk Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Prostate Cancer Stage I
Bladder Outlet Obstruction
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Life expectancy \>/= 10 years
2. Low risk prostate cancer with minor institutional amendment of EAU guidelines:

   * PSA \< 10 ng/ml or up to 20 ng/ml if PSA density is more than 15%
   * Stage T1, T2a.
   * Gleason score \<7 (ISUP grade 1)
3. Bladder outlet obstruction:

   * IPSS \> 9
   * Peak flow rate (Qmax \< 15)
   * Imperative indication for BOO surgery

Exclusion criteria:

* Patients who are not willing
* Patients with bladder dysfunction (cystopathy) or other infravesical cause of obstruction other than prostate

Primary outcomes:
measure: PSA progression
timeFrame: one year
measure: radiological progression
timeFrame: one year
Secondary outcomes:
measure: relief of bladder outlet obstruction
timeFrame: one year
measure: relief of lower urinary tract symptoms
timeFrame: one year
measure: 2 years progression free survival
timeFrame: 2 years
measure: 5 years progression free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and nephrology center
state: DK
Study officials:
affiliation: Mansoura University
name: Ahmed Elshal, MD
role: PRINCIPAL_INVESTIGATOR
References: