Prostate Cancer Stage IPhase 4NCT05631080
Transurethral Prostate Enucleation in Surveillance Protocol for Low Risk Prostate Cancer
A Phase 4 study testing Anatomical Endoscpic enucleation of the Prostate in people with Prostate Cancer Stage I and Bladder Outlet Obstruction, run by Mansoura University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Stage I, Bladder Outlet Obstruction
- What is being tested?
- Anatomical Endoscpic enucleation of the Prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- IPSS > 9
- Peak flow rate (Qmax < 15)
- Imperative indication for BOO surgery
Who cannot join
- Patients who are not willing
- Patients with bladder dysfunction (cystopathy) or other infravesical cause of obstruction other than prostate
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Being tested
- Anatomical Endoscpic enucleation of the Prostate
- Medical subject headings
- Prostatic Neoplasms, Urinary Bladder Neck Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical Endoscpic enucleation of the ProstateProcedure or surgery
Also called AEEP
Transurethral endoscopic enucleation of the prostate adenoma
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Anatomical Endoscpic enucleation of the Prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA progression
changes of PSA level from baseline to one year follow up following active treatment
Measured: one year
radiological progression
cancer progression as depicted by multiparametric MRI
Measured: one year
Secondary outcomes (4)
relief of bladder outlet obstruction
improvement of urine flow parameters as depicted by peak flow rate (ml/sec)
Measured: one year
relief of lower urinary tract symptoms
improvement of urinary symptoms as depicted by symptom score (International prostate symptom score)
Measured: one year
2 years progression free survival
PSA, Radiological and grade progression whenever biopsy is indicated
Measured: 2 years
5 years progression free survival
PSA, Radiological and grade progression whenever biopsy is indicated
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study startJan 2015
- Primary completionSep 2022
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Stage IStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elshal, Mansoura University
- Investigators
- Ahmed Elshal, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631080
- Sponsor's protocol ID
- Mans 22-4-2016
- Status last verified
- Nov 2022
- First submitted
- 19 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05631080
- Acronym / sponsor ID
- Mans 22-4-2016
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Sep 2022 (actual)
- Study completion
- Sep 2024 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Anatomical Endoscpic enucleation of the ProstatePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Life expectancy >/= 10 years
- Low risk prostate cancer with minor institutional amendment of EAU guidelines:
- Bladder outlet obstruction:
Key exclusion criteria (2 listed)
- Patients who are not willing
- Patients with bladder dysfunction (cystopathy) or other infravesical cause of obstruction other than prostate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomical Endoscpic enucleation of the ProstateAlso: AEEPTransurethral endoscopic enucleation of the prostate adenoma | Procedure or surgery | Surveillance with anatomical endoscopic enucleation of the prostate for bladder outlet obstruction |
Primary outcome
PSA progression
Time frame: one year
changes of PSA level from baseline to one year follow up following active treatment
radiological progression
Time frame: one year
cancer progression as depicted by multiparametric MRI
4 secondary outcomes
relief of bladder outlet obstruction
Time frame: one year
relief of lower urinary tract symptoms
Time frame: one year
2 years progression free survival
Time frame: 2 years
5 years progression free survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Elshal, MD principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anatomical Endoscpic enucleation of the Prostate in people with Prostate Cancer Stage I and Bladder Outlet Obstruction, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA progression (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.