Primary objectiveThe primary objective for this phase IIa study is to investigate the feasibility, usability and safety of CLS MR-guided FLA in the treatment of prostate cancer.Secondary objectiveTo assess tumor response and functional outcomes
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint
• Technical success, as determined by:
o Completion of the laser ablation without technical failures
o Achievement of complete ablation shown by MRI after treatment calculated
using image co-registration software.
• Total procedure time
• Total number of fiber positions and ablations needed
• Procedure-related adverse events and complications following SIR criteria
Secondary outcome
• Tumor response measured with MRI 6 months after treatment (Lack of
enhancement on dynamic contrast enhanced MR imaging in the treated area)
• Progression free survival at 6 months
• Functional outcome (i.e. urinary incontinence, and erectile dysfunction). The
IPSS and IIEF-5 (erectile dysfunctioning) at 6 weeks, 3, 6 and 12 months.
• Complication rates according to SIR system
• Local progression free survival
Background summary
Prostate cancer is the most frequent non-cutaneous malignancy in the western
male population, with almost 13,600 newly diagnosed patients in the Netherlands
in 2019 (1). Due to widespread use of the prostate-specific antigen (PSA) test
and the lowered PSA threshold for biopsy, the number of newly diagnosed
prostate cancers strongly increased in the last 20 years (2).
At present, treatment choice for prostate cancer patients at low or
intermediate risk of disease progression lies between active surveillance (AS)
and radical therapies, such as radical prostatectomy or radiotherapy. For these
patients, radical treatments have a comparable effectiveness, with a risk of
specific death of less than 1% in 15 years. However, none is devised of
consequences on the quality of life and can induce significant morbidities such
as incontinence and impotence (3-5).
For this reason, innovative ablation techniques such as cryosurgery, high
intensity focused ultrasound, photodynamic therapy and laser ablation therapy
have emerged and are increasingly applied in clinical practice. These treatment
methods aim for local destruction of cancerous cells using various sources of
energy (6). The main advantage of preservation of healthy prostatic tissue is
to reduce treatment-related complications and morbidity (7). Recent studies
demonstrate that post-treatment prognosis is predominantly driven by the
largest lesion with the highest grade, the so-called *index lesion* (7, 8).
Treatment approaches which preserve parts of the prostatic gland are considered
as focal therapy. Imaging plays an important role in detection, localization,
targeting and monitoring of focal prostate cancer treatment. Multi-parametric
magnetic resonance imaging (mpMRI) is preferred in detecting and staging
prostate cancer due to excellent soft tissue contrast and multiplanar
anatomical imaging (9, 10). It is also used to differentiate between
post-treatment changes and potential recurrent or residual disease. As such,
secondary treatment can be promptly established (11). More recently, mpMRI has
gained acceptance in image-guided therapeutic settings since it offers
real-time anatomical imaging in different planes and therefore improved
treatment accuracy (12). Furthermore it can provide real-time temperature
imaging.
Focal laser ablation (FLA) or laser-induced interstitial thermal therapy (LITT)
is a relatively new technique which was originally developed to treat brain
tumors. During this therapy, a laser fiber is positioned into the tumor under
image guidance (ultrasound or MRI). When the position of the fiber is correct,
laser light is delivered through the fiber and the temperature of the tissue
around the tip of the fiber increases. When temperature increases above 60°C
the tissue is irreversibly damaged and destroyed. The total ablation process
takes about 2-3 minutes. MRI is perfectly suited to use for image guidance
during FLA, because it can be used to localize the tumor, target it with
probes, monitor and control the ablation procedure in real-time and to map
tissue temperature.
Only a few studies on MRI-guided FLA are known. Lepor et al provided a pilot
study of 25 patients with low-intermediate risk prostate cancer undergoing FLA.
Three months after treatment, they showed no significant differences in
functional outcome according to the SHIM (Sexual Health in Man) and AUASS
(American Urological Association Symptom Score) questionnaires and no
incontinence. Furthermore, 96% of the ablation zones targeted with biopsy three
months after treatment, showed no histopathological prove of residual prostate
cancer. A recent study by Walser et al. demonstrated a freedom of retreatment
rate of 83% after a one year follow up in a group of 120 men with low- to
intermediate risk disease that underwent transrectal FLA with no significant
changes in quality of life or sexual and urinary function (15).
In Radboudumc we have several years of experience with MRI-guided focal laser
ablation for prostate cancer treatment. At this moment separate systems are
used for MR thermometry (IFE, Siemens) and laser energy control (Biolitec). CLS
offers a dedicated system which integrates laser energy control with MR
thermometry for ablation monitoring. Next to this, additional types of laser
fibers are available that are thought to produce relatively larger, more
adequate ablation zones (up to 3.0 x 2.0 cm) in comparison to current fibers.
In potential, this will decrease the total procedure time because less
ablations per lesion are needed and more patients will be eligible for FLA
because larger tumors can be treated.
This project has the purpose to assess the feasibility of MRI-guided FLA
treatment using the newly developed CLS system as well as its usability and
safety.
Study objective
Primary objective
The primary objective for this phase IIa study is to investigate the
feasibility, usability and safety of CLS MR-guided FLA in the treatment of
prostate cancer.
Secondary objective
To assess tumor response and functional outcomes
Study design
Single-center, interventional treatment, non-randomized, open label, single
arm, phase IIa study with a CE-labeled medical device. This phase 2 study will
be coordinated by the Radboudumc. Patients will be recruited from patients
presenting at the Radboudumc.
Intervention
MRI-guided focal laser ablation of prostate cancer
Study burden and risks
Possible complications associated with focal laser ablation are hemorrhage,
inflammation, minute risk of perforation of urethra or bladder, and fistula
formation. The use of MRI-guidance may have a burden of local heating and
noise, risks of contrast reactions against gadolinium, or serious unexpected
events and patient burden in form of time investment.
These drawbacks are outweighed by potential benefits for patients, since FLA
has a lower chance on developing impotence and incontinence when comparing it
to the standard treatment of radical prostatectomy of radiotherapy.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
• MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted
imaging); • maximum MRI visible lesion size is <= 20 mm large axis; • age 45 to
76 years old; • life expectancy at inclusion of more 10 years; • diagnosis of
prostate cancer confirmed by targeted biopsy; • criteria of low and
intermediate risk of progression and eligibility for focal therapy; o clinical
stage of maximum T2c o maximum biopsy Gleason score of 4 + 3 on targeted
biopsies o serum prostate specific antigen < 15 ng/ml • patient accepting to be
included in an active surveillance protocol at the end of the study, in
accordance with the recommendations of good practice.
Exclusion criteria
• History of prostate surgery; • history of radiation therapy or pelvic trauma;
history of proved acute or chronic prostatitis; • history of tumor in the
preceding 5 years (excluded: non-metastatic basal cell skin cancer); • severe
urinary symptoms associated with benign hyperplasia of the prostate, and
defined by an IPSS score > 18; • tumor with extra-capsular extension or
invasion of the seminal vesicles; • patients with >2 lesions; • impossibility
to obtain a valid informed consent; • patients unable to undergo MR imaging,
including those with contra-indications; • contra-indications to MR guided
focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal
resection); • metallic hip implant or any other metallic implant or device that
distorts local magnetic field and compromises the quality of MR imaging; •
patients with evidence for nodal or metastatic disease; • patients with an
estimated Glomerular Filtration Ratio (eGFR) < 40 mL/min/1.73 m2.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78437.091.21 |