Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05631080 |
Other study ID # |
Mans 22-4-2016 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
January 2015 |
Est. completion date |
September 2024 |
Study information
Verified date |
November 2022 |
Source |
Mansoura University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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.
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.