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Transurethral Prostate Enucleation in Surveillance Protocol for Low Risk Prostate Cancer

Primary Purpose

Prostate Cancer Stage I, Bladder Outlet Obstruction

Status
Active
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Anatomical Endoscpic enucleation of the Prostate
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer Stage I

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion criteria: Patients who are not willing Patients with bladder dysfunction (cystopathy) or other infravesical cause of obstruction other than prostate

Sites / Locations

  • Urology and nephrology center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Surveillance with medical treatment for bladder outlet obstruction

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

Arm Description

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

Outcomes

Primary Outcome Measures

PSA progression
changes of PSA level from baseline to one year follow up following active treatment
radiological progression
cancer progression as depicted by multiparametric MRI

Secondary Outcome Measures

relief of bladder outlet obstruction
improvement of urine flow parameters as depicted by peak flow rate (ml/sec)
relief of lower urinary tract symptoms
improvement of urinary symptoms as depicted by symptom score (International prostate symptom score)
2 years progression free survival
PSA, Radiological and grade progression whenever biopsy is indicated
5 years progression free survival
PSA, Radiological and grade progression whenever biopsy is indicated

Full Information

First Posted
November 19, 2022
Last Updated
November 19, 2022
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05631080
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2015 (Actual)
Primary Completion Date
September 2022 (Actual)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Stage I, Bladder Outlet Obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surveillance with medical treatment for bladder outlet obstruction
Arm Type
No Intervention
Arm Description
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
Arm Title
Surveillance with anatomical endoscopic enucleation of the prostate for bladder outlet obstruction
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Anatomical Endoscpic enucleation of the Prostate
Other Intervention Name(s)
AEEP
Intervention Description
Transurethral endoscopic enucleation of the prostate adenoma
Primary Outcome Measure Information:
Title
PSA progression
Description
changes of PSA level from baseline to one year follow up following active treatment
Time Frame
one year
Title
radiological progression
Description
cancer progression as depicted by multiparametric MRI
Time Frame
one year
Secondary Outcome Measure Information:
Title
relief of bladder outlet obstruction
Description
improvement of urine flow parameters as depicted by peak flow rate (ml/sec)
Time Frame
one year
Title
relief of lower urinary tract symptoms
Description
improvement of urinary symptoms as depicted by symptom score (International prostate symptom score)
Time Frame
one year
Title
2 years progression free survival
Description
PSA, Radiological and grade progression whenever biopsy is indicated
Time Frame
2 years
Title
5 years progression free survival
Description
PSA, Radiological and grade progression whenever biopsy is indicated
Time Frame
5 years

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
prostate disorder only in males
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion criteria: Patients who are not willing Patients with bladder dysfunction (cystopathy) or other infravesical cause of obstruction other than prostate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Elshal, MD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology and nephrology center
City
Mansoura
State/Province
DK
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Transurethral Prostate Enucleation in Surveillance Protocol for Low Risk Prostate Cancer

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