Phase II Laser Focal Therapy of Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 45 - 90 |
| Updated: | 7/27/2018 |
| Start Date: | May 2016 |
| End Date: | November 2036 |
| Contact: | Bernadette M. Greenwood, BSc., PG Cert. |
| Email: | bernadette.greenwood@desertmedicalimaging.com |
| Phone: | 760-766-2047 |
A Phase II Study to Evaluate Outpatient Magnetic Resonance Image-guided Laser Focal Therapy for Prostate Cancer, a 20-year Survival Study
Target recruitment: 1000 subjects. The purpose of this research study is to continue to
investigate the safety and effectiveness of using MR (magnetic resonance) guided laser focal
therapy for prostate cancer and to evaluate oncologic control over 20 years. We hypothesize
that laser focal therapy can be used to achieve oncologic control in carefully selected
patients.
MR uses large magnets to produce pictures of areas/organs inside the body. The laser uses
light to heat a target area to try to destroy cancerous cells.
The laser system that will be used is called the Visualase® Thermal Therapy System. This
system has been used for the treatment of brain, bone (spine), thyroid, and liver cancers.
However; this study is the first time this system has been studied for use in the treatment
of prostate cancer with a trans-rectal approach.
MR-guided biopsies and laser applicator placement will be performed using the Invivo DynaTRIM
trans-rectal biopsy guidance system. This system is cleared (approved) by the U.S. Food and
Drug Administration (FDA) for such uses.
investigate the safety and effectiveness of using MR (magnetic resonance) guided laser focal
therapy for prostate cancer and to evaluate oncologic control over 20 years. We hypothesize
that laser focal therapy can be used to achieve oncologic control in carefully selected
patients.
MR uses large magnets to produce pictures of areas/organs inside the body. The laser uses
light to heat a target area to try to destroy cancerous cells.
The laser system that will be used is called the Visualase® Thermal Therapy System. This
system has been used for the treatment of brain, bone (spine), thyroid, and liver cancers.
However; this study is the first time this system has been studied for use in the treatment
of prostate cancer with a trans-rectal approach.
MR-guided biopsies and laser applicator placement will be performed using the Invivo DynaTRIM
trans-rectal biopsy guidance system. This system is cleared (approved) by the U.S. Food and
Drug Administration (FDA) for such uses.
Laser-induced interstitial thermal therapy (LITT) is a novel form of controlled, targeted
thermal ablation that may offer measurable advantages over other ablative therapies for focal
prostate therapy. Because LITT is magnetic resonance (MR) compatible, it enables an imaging
advantage over other surgical or ablation techniques that utilize transrectal ultrasound to
target and monitor treatment. MR imaging provides excellent soft-tissue contrast and
three-dimensional (3D) anatomical imaging in any arbitrary plane, which can help to improve
treatment planning and targeting. Additionally, MR-based temperature monitoring allows
real-time feedback during MRI-guided thermal therapy as both deposition of light energy and
MR signal acquisition can be performed simultaneously without degradation in the MR signal.
Also, being in the MR diagnostic environment allows use of post- treatment imaging to verify
tissue damage. Because MR images clearly depict the prostate anatomy and the surrounding
critical structures, MR imaging has been incorporated into planning for external- beam
radiotherapy, brachytherapy, and other treatments of the prostate. In addition to these basic
features, Multiparametric prostate MRI (mpMRI) may be used to identify regions of disease in
the prostate and better target therapy.
In this study, the investigators propose to evaluate the efficacy of a novel, FDA-approved
thermal therapy and feedback system (Visualase® Thermal Therapy System) for the treatment of
biopsy confirmed and MR-imageable prostate lesions. This system has been used in humans for
the treatment of brain, bone (spine), thyroid, and liver cancers. Early feasibility studies
for prostate cancer used a transperineal approach; however it is now being evaluated for the
primary treatment of prostate cancer using a transrectal approach. This system allows
delivery of laser energy while the patient is simultaneously being imaged by an MRI unit. The
system's real-time MR thermal imaging (MRTI) provides information on the thermal dose
delivered to the target, resulting in a more precise and controlled delivery which has
previously not been possible with other ablative therapies. The investigators hypothesize the
system can be integrated into a practical and feasible outpatient treatment paradigm for
focal treatment of localized prostate cancer and allow patients to avoid the complications
associated with radical whole-gland therapy.
thermal ablation that may offer measurable advantages over other ablative therapies for focal
prostate therapy. Because LITT is magnetic resonance (MR) compatible, it enables an imaging
advantage over other surgical or ablation techniques that utilize transrectal ultrasound to
target and monitor treatment. MR imaging provides excellent soft-tissue contrast and
three-dimensional (3D) anatomical imaging in any arbitrary plane, which can help to improve
treatment planning and targeting. Additionally, MR-based temperature monitoring allows
real-time feedback during MRI-guided thermal therapy as both deposition of light energy and
MR signal acquisition can be performed simultaneously without degradation in the MR signal.
Also, being in the MR diagnostic environment allows use of post- treatment imaging to verify
tissue damage. Because MR images clearly depict the prostate anatomy and the surrounding
critical structures, MR imaging has been incorporated into planning for external- beam
radiotherapy, brachytherapy, and other treatments of the prostate. In addition to these basic
features, Multiparametric prostate MRI (mpMRI) may be used to identify regions of disease in
the prostate and better target therapy.
In this study, the investigators propose to evaluate the efficacy of a novel, FDA-approved
thermal therapy and feedback system (Visualase® Thermal Therapy System) for the treatment of
biopsy confirmed and MR-imageable prostate lesions. This system has been used in humans for
the treatment of brain, bone (spine), thyroid, and liver cancers. Early feasibility studies
for prostate cancer used a transperineal approach; however it is now being evaluated for the
primary treatment of prostate cancer using a transrectal approach. This system allows
delivery of laser energy while the patient is simultaneously being imaged by an MRI unit. The
system's real-time MR thermal imaging (MRTI) provides information on the thermal dose
delivered to the target, resulting in a more precise and controlled delivery which has
previously not been possible with other ablative therapies. The investigators hypothesize the
system can be integrated into a practical and feasible outpatient treatment paradigm for
focal treatment of localized prostate cancer and allow patients to avoid the complications
associated with radical whole-gland therapy.
Inclusion Criteria:
Treatment Naïve patients:
- Male, 45 years of age or older.
- Diagnosis of prostate adenocarcinoma.
- Clinical stage T1c or T2a.
- Gleason score of 7 (3+4 or 4+3) or less.
- Three or fewer biopsy cores with prostate cancer.
- PSA density not exceeding 0.375.
- One, two, or three tumor suspicious regions identified on multiparametric MRI.
- Negative radiographic indication of extra-capsular extent.
- Karnofsky performance status of at least 70.
- Estimated survival of 5 years or greater, as determined by treating physician.
- Tolerance for anesthesia/sedation.
- Ability to give informed consent.
- At least 6 weeks since any previous prostate biopsy.
- MR-guided biopsy confirmation of one or more MRI-visible prostate lesion(s) with
Gleason score of 7 (3+4 or 4+3) or less.
Salvage candidates will be accepted upon physician referral.
Exclusion Criteria:
- Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
- Severe lower urinary tract symptoms as measured by an International Prostate Symptom
Score (IPSS) of 20 or greater
- History of other primary non-skin malignancy within previous three years.
- Diabetes
- Smoker
We found this trial at
1
site
Indian Wells, California 92210
Principal Investigator: John F. Feller, MD
Phone: 760-766-2047
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