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Status unknownNCT05631080Updated Nov 30, 2022

Transurethral Prostate Enucleation in Surveillance Protocol for Low Risk Prostate Cancer

A Phase 4 interventional study of Anatomical Endoscpic enucleation of the Prostate in Prostate Cancer Stage I and Bladder Outlet Obstruction, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-30.

Sponsored by Mansoura University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 7 years 10 months after the study started (first participant enrolled Jan 2015, registered Nov 2022).
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Prostate Cancer Stage I
  • Bladder Outlet Obstruction
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. >/= 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

Exclusion criteria:

  • Patients who are not willing
  • Patients with bladder dysfunction (cystopathy) or other infravesical cause of obstruction other than prostate
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • No intervention
    Surveillance with medical treatment for bladder outlet obstruction

    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

  • Active comparator
    Surveillance with anatomical endoscopic enucleation of the prostate for 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

    Procedure: Anatomical Endoscpic enucleation of the Prostate

Interventions

  • ProcedureAnatomical Endoscpic enucleation of the Prostate

    Transurethral endoscopic enucleation of the prostate adenoma

    Also known as: AEEP

06

What researchers measure

Primary outcomes

  1. PSA progression

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

    Time frame: one year

  2. radiological progression

    cancer progression as depicted by multiparametric MRI

    Time frame: one year

Secondary outcomes

  1. relief of bladder outlet obstruction

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

    Time frame: one year

  2. relief of lower urinary tract symptoms

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

    Time frame: one year

  3. 2 years progression free survival

    PSA, Radiological and grade progression whenever biopsy is indicated

    Time frame: 2 years

  4. 5 years progression free survival

    PSA, Radiological and grade progression whenever biopsy is indicated

    Time frame: 5 years

07

Study locations

1 site
  • Urology and nephrology center
    Mansoura, DK 35516, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05631080
Responsible party
Ahmed Elshal (A. Professor of Urology, Mansoura University) — Principal investigator
First posted
Nov 30, 2022
Start date
Jan 2015
Primary completion
Sep 2022
Completion
Sep 2024 (estimated)
Last update
Nov 30, 2022

Study contacts

Ahmed Elshal, MD
principal investigator · Mansoura University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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