Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04760483 |
| Other study ID # |
URN-20201001 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
November 20, 2020 |
| Est. completion date |
March 20, 2026 |
Study information
| Verified date |
January 2023 |
| Source |
Urological Research Network, LLC |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is set up as a phase I-II prospective, single center, interventional pilot study
carried in Office setting under local anesthesia. It will assess the impact in quality of
life and adverse events produced by transperineal laser ablation of the prostate (TPLA) in
men 40 to 85 years of age with benign prostatic hypertrophy (BPH).
BPH is currently managed with medications (ie, alpha-1 adrenergic medications) and/or
invasive approaches such as transurethral resection of prostate or surgical excision of
prostate - robotic or open lead to relaxation or excision of the bladder neck. Such
alteration of the bladder neck function or anatomy portends a significant and noticeable
change on a male lifestyle, represented by absence of antegrade ejaculation among others.
This study aims to evaluate the use of TPLA in the office setting under local anesthesia -
greatly decreasing patient perioperative surgical risk. Moreover, it aims to determine safety
profile and outcomes from TPLA therapy
The fundamental objective is to determine the feasibility and safety of TPLA in healthy men
with LUTS due to BPH, successful performed in the outpatient office-based setting under local
anesthesia. Secondary objectives include: 1-Uroflowmetry and Patient Reported Outcome
Measures (PROMs) at three, six and 12 months; 2-Immediately spontaneous voiding post-TPLA;
3-Hematuria incidence after TPLA, measured by patient reporting; 4-LUTS after the treatment
measured by IPSS; 5- Erectile function and presence of ejaculation after TPLA treatment and
6-Prostate volume changes using Transrectal ultrasound (TRUS) volume measurements
Description:
INTRODUCTION
The Echolaser system (ELS - Elesta SpA. 50041, Calenzano (FI), Italy ), which consists of
Echolaser X4 plus Echolaser Smart Interface is a new device for minimal invasive procedures.
The system induces tissue coagulation thru a continuous 1064 nm laser wave. Light tissue
interaction is reliable, reproducible, and safe. The laser fiber tip induces necrosis near
the tip and coagulative effects deeper in tissues thru heat ablation. The body cleans up
treated tissue over time. Much experience is gained with laser application in different
organs. A preliminary study conducted in Europe by the investigators showed promising results
(1)
About 4 out 5 men experience bothersome alterations in their voiding pattern. This pervasive
condition usually begins in the 5th decade of life. These patients usually express complaints
of Urinary urgency, frequency and nocturia as the sensation of incomplete voiding and
decrease in the force of stream leading to stranguria. Lower Urinary Tract Symptoms (LUTS) is
the common term that represents constellation of these symptoms, most triggered by prostate
enlargement, commonly referred as Benign Prostatic Hyperplasia (BPH). Today management of BPH
may call for medications such as alpha-blockers, 5 alpha reductase inhibitors,
phosphodiesterase inhibitors or combination of them. In addition, there surgical approaches
to improve BPH, they are based on cytodestruction or excision of prostate tissue. These
surgical approaches range from office based minimally invasive to hospital based robotically
conducted. Office based minimally invasive approaches are favored by patients given their
low-risk nature, safety profile and avoidance of general or spinal anesthesia. Furthermore,
minimally invasive approaches aim to preserve the bladder neck, this avoids alterations in
sexual function such as retrograde ejaculation. Excision or resection of the bladder neck is
a major step of definitive invasive approaches such as transurethral resection of prostate or
surgical excision of prostate - robotic or open. Bladder neck resection portends a
significant and noticeable change on a male lifestyle, represented by absence of antegrade
ejaculation. This is a tradeoff that evokes hesitation in many men to resolve their BPH.
Minimally invasive procedures have emerged aiming to relieve BPH without sacrificing the
bladder neck. They carry two major advantages: preservation of ejaculation and absence of
major anesthesia requirements, thus amenable to office setting execution. The latter provides
significant saving to the health system and decreases post-operatory risks of adverse events
in a not insignificant manner. The fundamental question raised to minimal invasive procedures
relates to degree of subjective and objective response, durability of BPH relief, ability to
wean off from medications and impact on quality of life, from a two domain - urinary and
sexual perspective.
The ELS is a novel disruptive approach that allows a transperineal approach and provides for
a safe and simultaneous multiple laser fiber energy delivery that translated in expediency
and decreased procedure times. ELS has been safely conducted in men with BPH in the
ambulatory setting, as a procedure called SoracteLiteTM transperineal laser ablation (TPLA),
performed in men with LUTS due to BPH that were suboptimal candidates for surgery, they
exhibited good tolerability with minimal adverse event profiles. To the investigators
knowledge, there is no data or evaluation of its safety profile if/when conducted in an
office setting under local anesthesia. Therefore, in this study the investigators aim to
assess efficacy, tolerability, response and safety profile of SoracteLite™ TPLA conducted in
men with LUTS due to BPH in the office setting.
Objective: The primary objective of this study is to assess efficacy, tolerability, short
term response and safety profile of SoracteLite™ TPLA for LUTS due to BPH in healthy men. The
secondary objectives are to evaluate quality of life changes in erectile and sexual function
as the well as imaging volumetric changes in prostate size.
Study design: This study is set up as prospective, single center, interventional study.
Study population: The study will be offered to men ≥ 40 years of age, with moderate or severe
international prostate symptoms scores and concomitant objective decrease in flow studies of
at 30% consistent with bladder outlet obstruction (Qmax of 5 - 15 mL/sec, Elevated voiding
pressures consistent with bladder outlet obstruction) Study Intervention Upon meeting
inclusion and exclusion criteria, subjects will undergo prostate transperineal laser ablation
planning and execution under local anesthesia using the ELS. Planning and execution will aim
to destroy the prostate adenoma or transitional-anterior zones while sparing critical
structures such as the urethra, neurovascular bundles, and bladder neck. The investigators
anticipate between one and four laser fibers would be placed in the prostate to induce the
laser coagulative necrosis required to achieve desired response.
Main study parameters/endpoints: Fundamental study parameters are efficacy and safety.
Efficacy will be measured in changes- improvement in IPSS score and uroflowmetry parameter as
Qmax and Post void volume profile of the procedures measured by successfully completed
SoracteLiteTM TPLA procedures. For safety, the main study parameter is the number of grade 3
or worse adverse events based on the CTCAE v5.0 within 30 days post procedure.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: The risks for participation in this study are related to the SoracteLiteTM TPLA
procedure. Laser fibers are introduced in the prostate by needles and these could injure and
damage surrounding tissues. For example, plausibly, perforation of the urethra could lead to
hematuria, clot retention and urinary tract infections. The laser energy delivery could
damage vessels and nerves evoking erection changes, even loss. Thermal injuries from the
laser could lead to communication with rectum leading to infections and fistulas.
Furthermore, the prostatic tissue may become quite edematous triggering urinary retention
that would require an indwelling catheter for several days or the weeks and may even trigger
a need for of transurethral resection.
Granted, several precaution actions will be undertaken to reduce the patients' risk, such as:
1. Patients will be instructed to self-administer a fleet enema, the evening before and
morning of the procedure.
2. The procedure will be performed under local anesthesia; thus, patient will be awake and
able to provide feedback while it takes placed.
3. Single dose intravenous antibiotic prophylaxis with either cefuroxime or gentamicin will
be provided.
4. Echolaser Smart Interface will be used for the planning of the treatment taking care of
the safety distance in longitudinal and transversal US planes.
5. The laser fibers will be placed following the plan under live co-registered ultrasound
guidance.
6. Laser ablation will be monitored in real time and restricted to the safety margins
established on the plans, thus other critical anatomic areas will be spared.
7. Patients will be transferred to a recovery room and be discharge when subjectively they
feel better and objectively have stable vital signs and full respiratory, cardiac,
neurological and musculoskeletal capacities.
The following represent advantages of SoracteLiteTM TPLA: minimal invasive procedure;
performance under local anesthesia; the intent is to treat transition-anterior zone, so
called surgical capsule; urethral sparring, preservation of bladder neck and antegrade
ejaculation, limited to absent need of indwelling catheterization.
The investigators aim to streamline the follow up following standard of care. Patients will
be instructed to call if they perceive any adverse event. Patients will be contacted 30 days
after procedure and an adverse event questionnaire will be administered. Subjective quality
of life survey instruments will be administered 6 weeks and 3, 6 and 12 months from procedure
date. Flow and volumetric studies will be conducted 3 months from procedure date.
In Conclusion, SoracteLiteTM TPLA will expose patients to intervention risks. However, is the
investigators estimation and bias these will be favorable or equal to those observed with
compared available standard minimal invasive treatment approaches. The burden is in our
opinion acceptable.
