Trial Title:
TRANBERG® Transperineal MR/US Fusion Laser--Induced Thermal Therapy for Men With Prostate Cancer
NCT ID:
NCT05698576
Condition:
Prostate Cancer
Adverse Effects Surgery
MRI
Ultrasound
Sexual Function Disturbances
Urinary Incontinence
Urinary Function Disorders
Prostate Biopsy
Ablation
Conditions: Official terms:
Prostatic Neoplasms
Urinary Incontinence
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Voluntary participation in a Prospective controlled cohort
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT)
Description:
A perineal local anesthesia block is performed with patient on lithotomy. The ultrasound
probe is advanced, secured to digital stepper. The live ultrasound image feed is visible
on the FOCALYX® Fusion device. Image co-registration (MR/US) will be performed. The
FOCALYX® Fusion device shows outline of the prostate on the MRI and the target area(s) in
real-time. The urologist advances laser fiber introducer, temperature probes to indicated
coordinates. Target treatment - applying TRANBERG® laser energy over the treatment area
and controlling delivery with a pedal. Treatment is monitored using FOCALYX® Fusion
device in real-time. One laser fiber will be used and a single or multiple applications
may be required. The fiber will be relocated to other targets if present. Patient will be
dismissed to the MRI center where a multiparametric MRI will be conducted. After this
study is completed, the patient will be discharged home with instructions and contact
information.
Arm group label:
TPF-LITT ARM
Other name:
Fusion Imaging Laser induced thermal therapy for prostate partial gland ablation.
Summary:
This study is set up as a phase I prospective, single center, device interventional pilot
study carried in office setting under local anesthesia. It will assess the tolerance and
safety of target fusion ablation of prostate cancer tumors using Laser Induced Thermal
Therapy (TFA-LITT) guided by fusion imaging in men 50 to 80 years of age with low to
intermediate risk prostate cancer
Prostate Cancer is currently managed with in a discrete fashion where patients either
enroll in active surveillance protocols (No intervention) or undergo full intervention
via whole gland treatments - most commonly radical surgery or radiation. These treatments
have not shown definitive gains in all cause survival and not uncommonly harbor
undesirable adverse effects, most notably: impotency and incontinence. Such events elicit
significant and noticeable changes on a male lifestyle and for most prostate cancer
tumors are considered overtreatment. This study aims to evaluate the use of TFA-LITT in
the office setting under local anesthesia - greatly decreasing patient perioperative
surgical risk - focused on the organ sparing cancer lesion ablation, where organ function
is preserved.
The fundamental objective is to determine the tolerance and safety of TFA-LITT in men
with low to intermediate risk prostate cancer, successful performed in the outpatient
office-based setting under local anesthesia directed by fusion imaging. Secondary
objectives include: 1-Biopsy proven cancer control of ablated areas 12 months after
procedure; 2-Uroflowmetry and urinary function Patient Reported Outcome Measures (PROMs)
at one, three, six, nine and 12 months; 3- Sexual function Patient Reported Outcome
Measures (PROMs) at one, three, six, nine and 12 months; 4- MRI changes of ablated area
one, three and 12 months after TFA-LITT; 5- Absence or presence of ejaculation after
TFA-LITT.
Detailed description:
The field of urology currently demands better options for men diagnosed with prostate
cancer, the most common solid tumor in the US and Western Europe. Recently, active
surveillance has become a main alternative for patients and physicians seeking to avoid
the overtreatment phenomenon associated with standard treatments. However, most men on
surveillance protocols for prostate cancer end up converting to "definitive" management
whether surgery or radiation within 5 years from diagnosis.
The TRANBERG®|Thermal Therapy System (Clinical Laserthermia Systems AB. Scheelevägen 2 |
223 81 Lund, Sweden), is a 25 W, 1064 nm diode laser. It uses a disposable laser
applicator 14G that allows the insertion of a laser applicator (15G) with a fiberoptic
core of 550µm. This thermal therapy laser system is indicated for minimal invasive
ablation procedures so called Laser Induced Thermal Therapy (LITT) or also called Laser
Ablation for prostate treatments. During LITT, light causes damage in tissue due to
absorption of light and through heat conduction into the tissue of the absorbed energy.
Light tissue interaction is reliable, reproducible, and safe. The laser fiber tip induces
necrosis near the tip and coagulative effects deeper in tissues through heat conduction.
The body cleans up treated tissue over time. Much experience is gained with laser
ablation in different organs.
The development of medical fusion devices that incorporate the precise diagnostic
findings from MRI with the flexibility of ultrasound has expanded the precision of
prostate biopsies and has led thinking into the current management of prostate cancer,
opening for consideration the case for partial gland ablation as an option with fewer
side effects.12 Conceivably, the most promising role of fusion imaging would be in the
management spectrum of prostate cancer. MRI/US fusion imaging has tremendous advantages,
it delivers precise anatomical boundaries and perspectives to surgeons as they sought to
destroy cancer lesions and spare healthy tissue. A better understanding on their role in
ablation treatments is imperative.
The Focalyx® Fusion (Focalyx, 2140 West 68th St, #204a. Miami Lakes, FL, USA) is a novel
disruptive medical device that enables an office based transperineal approach to be
conducted using real-time fusion. The characteristics of this fusion device and trials
studies have been well documented. This theoretically makes available a safe and laser
fiber energy delivery that results in expedient and short procedure times. The Focalyx®
Fusion has been used safely in the transperineal diagnosis (fusion biopsies) and
management (fusion targeted cryoablation) of men with Prostate Cancer in the office
setting. However, targeted prostate cryoablation carries some intrinsic disadvantages as
it requires high pressure gasses. Argon and helium are not readily available worldwide,
and its efficacy depends on several timely cycles demanding procedure times of about an
hour or more. LITT can be accomplished in efficient minutes treatment times and can
address the multi-focality of prostate cancer quite effectively. Laser ablation has
proven effective when conducted in an MRI bore, however, the immensity of these machines,
limited size of the bore, prone positioning and constant in and out verification makes
this approach not practical. Fusion laser ablation for prostate cancer is a novel concept
that can bring together the precision of MRI with the practicality of ultrasound.
The combination of the TRANBERG® laser and the FOCALYX® Fusion medical device will allow
us to perform targeted transperineal fusion laser induced thermal therapy (TPF-LITT) of
prostate cancer lesions. This approach portends significant advantages that the
investigators can consider, among them: lesion directed ablation, sparring of critical
organs and structures such as the bladder neck, NVB, urethral sphincter and rectum.
Moreover, healthy tissue is spared and can perform its function, if it mirrors what the
investigators have accomplished with target fusion cryoablation. It shall be expected
that most men will have preservation of some ejaculation, mild changes in sexual function
and no incontinence following treatment with TPF-LITT. In fact, from a urinary function
status, the investigators expect patients to suffer no harm either subjectively or
objectively. However, all these thoughts require rigorous evaluation. Today, 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 principal aim is to assess tolerability
and safety profile of TRANBERG® TPF-LITT conducted in men with Prostate Cancer in the
office setting.
Objective: The primary objective of this study is to assess tolerability and safety, of
TRANBERG® TPF-LITT in Prostate Cancer patients with clinically localized disease. The
secondary objectives are to evaluate clinical performance, changes in erectile and sexual
function as well as imaging volumetric changes in prostate lesions, prostate size as well
as cancer control in treated areas Study design: This study is set up as open label,
prospective, single center, interventional study.
Study population: Patients with low or intermediate risk prostate cancer ≥ 50 years of
age.
Study Intervention: Upon meeting inclusion and exclusion criteria, subjects will undergo
prostate ablation planning where the ablation areas will be noted irrespective of
location so long, they are confined to this organ. The planning will allow to spare, if
possible, critical structures such as the urethra, neurovascular bundles, and bladder
neck. TRANBERG® TPF-LITT treatment execution will be conducted under local anesthesia
using the FOCALYX® Fusion medical device as guidance for precise laser fiber localization
and real-time monitoring. This investigation will employ a single fiber that will be
repositioned to destroy several targeted areas to achieve the TFP-LITT goals. The surgeon
will deliver the laser energy and adjust if needed. The areas treated will develop
coagulative necrosis with scarring as a response to TPF-LITT. Upon conclusion of the
procedure, the patient will have a multiparametric MRI of the prostate to determine the
extent of ablation with this powerful technology immediately after treatment, and
subsequently 1, 3 and 12 months after.
Main study parameters/endpoints: Tolerability and safety represents the main endpoints of
this trial. Tolerability will be assessed during the execution of TFP-LITT. Patients will
be provided with a pain analog scale and pain scores will be recorded before initiation
of the procedure and during several milestones of the procedure. A final overall pain
assessment will be recorded as well. Safety will be assessed during the 7-day, 30-day and
90-day clinic visits. Adverse events (AEs) will be monitored and reported using the CTCAE
scale, as perioperative assessments will be conducted at each of these milestones. A
grade 3 or worse AEs based on the CTCAE v5.0 within 90 days post procedure will be
considered severe. Secondary outcomes will include cancer control, urinary and sexual
functional outcomes. Cancer control will be measured with MRI at several milestones,
serum PSA changes during the year and the definitive measure will be a Transperineal
MR/US Fusion Biopsy at one year of follow up. Urinary and Sexual functional outcomes will
be determined by evaluating changes in the validated questionnaires. Ejaculation will be
monitored by direct questions.
The investigators aim to streamline the follow up focusing on safety according to
standard of care. Patients will be instructed to contact us if they perceive any AEs. The
principal investigator will oversee each patient for any AEs. Patients will be followed
up in the clinic 7 days post procedure for catheter removal and AEs assessments. They
will be contacted 30 days after the procedure and an AEs questionnaire will be
administered as well. AEs, IPSS and SHIM assessments will be done at the 6 weeks and
3-month visits. IPSS and SHIM assessments will be done at the 6-month, 9-months and
12-months visits. Flow and volumetric studies will be conducted 3 months and 12 months
from procedure date. From an oncological perspective, patients will have serum markers
evaluations - PSA, Testosterone Creatinine and GFR measurements prior to a
multiparametric MRI and subsequently before each MRI at months 1, 3 and 12 after TPF-LITT
procedure. Critically, the Focalyx® Fusion device will be used to assess the delta
changes for each lesion and overall change in prostate configuration after each MRI
performed. This will allow further understanding of the speed of tissue retraction,
remodeling, and spatial orientation of the treated areas for each patient. Finally at 12
months, a MR/US Transperineal fusion biopsy will be performed to assess the ablated
tissue cancer sterility.
In Conclusion, TRANBERG® TPF-LITT will expose patients to potential intervention risks.
However, it is our estimation and bias these potential risks will be favorable or equal
to those observed with compared available standard minimal invasive treatment approaches
such as active surveillance. The risks usually associated with transrectal procedures is
eliminated as all treatments will performed via a transperineal access. The burden is in
our opinion favorable and acceptable.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Willing and able to sign informed consent
- Subject is able and willing to complete all procedure and follow-up visits indicated
in the protocol
- Absence of urinary retention
- Prostate volume: ≥ 18 and ≤ 100 cc, measured by transrectal ultrasound
- Serum creatinine levels <2 ng/dl and GFR > 45
- Serum PSA levels < 20 ng/ml
- Multiparametric prostate MRI with piRADS scores 3-5
- Prostate volume: ≥ 18 and ≤ 100 cc, measured by MRI
- Presence of Intermediate risk prostate cancer with a volume that is less than 1/3 of
the gland volume by MRI evaluation
Exclusion Criteria:
- Post-void residual (PVR): > 250 mL or > 50% of voided volume
- Previous prostate cancer intervention (Radiation therapy, brachytherapy, prostate
cryoablation
- Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis,
ALS, spinal cord injury
- Evidence of neurogenic bladder determined by urodynamics studies
- Presence of Indwelling Foley catheter or on active regime of clean intermittent
catheterization (CIC) in the prior 30 days
- Active urinary tract infection determined by urinary cultures
- SHIM score <14
- IPSS score >23
- Acute prostatitis
- Macroscopic hematuria without a known contributing factor
- History of colorectal carcinoma with anterior perineal resection of rectum
- History of pelvic radiation therapy or radical pelvic surgery
- History of bladder neck contracture and/or urethral strictures within the 5 years
prior to the informed consent date
- Bladder stones
- Medical contraindication for undergoing TPFLA surgery (eg, infection, coagulopathy,
significant cardiac or other medical risk factors for surgery)
- Diagnosed or suspected bleeding or coagulopathic disorder such as hemophilia, ITP,
TTP
- Medical contraindication to being subjected to local anesthesia
Gender:
Male
Minimum age:
50 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Urology Specialist Group
Address:
City:
Hialeah
Zip:
33016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Isabel H Lopez, MS, MBA
Phone:
786-431-2014
Email:
isabel@research.surgery
Contact backup:
Last name:
Gabriela Soriano
Phone:
7864312014
Email:
gabriela@besturology.net
Start date:
March 16, 2022
Completion date:
January 30, 2033
Lead sponsor:
Agency:
Urological Research Network, LLC
Agency class:
Other
Source:
Urological Research Network, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05698576
http://doi.org/10.1097/01.JU.0000557333.56091.01
http://doi.org/10.1097/JU.0000000000002111.10
http://doi.org/10.1097/JU.0000000000002023.03
