Transurethral Prostate Enucleation in Surveillance Protocol for Low Risk Prostate Cancer

NCT05631080 | Unknown Phase 4 DMC

• 1 other identifier: Mans 22-4-2016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer Stage I; Bladder Outlet Obstruction

Outcome Measures

Primary Outcomes (2)

• PSA progression

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

  one year

• radiological progression

  cancer progression as depicted by multiparametric MRI

  one year

Secondary Outcomes (4)

• relief of bladder outlet obstruction

  one year

• relief of lower urinary tract symptoms

  one year

• 2 years progression free survival

  2 years

• 5 years progression free survival

  5 years

Study Arms (2)

Surveillance with medical treatment for bladder outlet obstruction

NO INTERVENTION

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

Surveillance with anatomical endoscopic enucleation of the prostate for bladder outlet obstruction

ACTIVE COMPARATOR

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

Procedure: Anatomical Endoscpic enucleation of the Prostate

Interventions

Anatomical Endoscpic enucleation of the Prostate PROCEDURE

Transurethral endoscopic enucleation of the prostate adenoma

Also known as: AEEP

Surveillance with anatomical endoscopic enucleation of the prostate for bladder outlet obstruction

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: prostate disorder only in males
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Life expectancy \>/= 10 years
• 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)
• Bladder outlet obstruction:
• IPSS \> 9
• Peak flow rate (Qmax \< 15)
• Imperative indication for BOO surgery

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and nephrology center

Al Mansurah, DK, 35516, Egypt

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Bladder Neck Obstruction

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases

Study Officials

• Ahmed Elshal, MD

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A. Professor of Urology

Study Record Dates

• First Submitted: November 19, 2022
• First Posted: November 30, 2022
• Study Start: January 1, 2015
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2024
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)