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The main objective of this study is to evaluate the safety and feasibility of MRI guided focal prostate cancer laser ablation in males, ages 45-80 with biopsy confirmed early clinical stage prostate cancer (T1c or T2a) and identifiable lesion on endorectal dynamic Gadolinium enhanced MRI, with a PSA of < 10ng/ml, who have not yet undergone pelvic radiation or hormonal deprivation therapy.
This is a single center, single arm, open-label study to evaluate the safety and feasibility of MRI guided focal prostate cancer laser ablation in patients with a focus of prostate cancer who has not yet received treatment for their cancer. Patients fulfilling the inclusion criteria and having none of the clinical exclusion criteria will be enrolled into the study after they (or their legal representative) have signed the informed consent form. No control group will be utilized and all patients will receive MRI guided FLA for their focal prostate cancer. As part of the screening process, patients will provide a medical history and undergo a physical examination, including a digital rectal examination (DRE). At the first visit, patients will also be given a copy of the informed consent, and a copy of quality of life and performance questionnaires to assess urinary, rectal, and erectile functions (IPPSS questionnaire for urinary, IIEF5 questionnaire for erectile function, Porpus for all). MR imaging at visit 2 will serve to determine if a single site of prostate cancer can be localized. At visit 3, 12 cores transrectal us guided prostate biopsy will confirm yet again that this is a unilateral, unifocal histologicaly proven tumour in the site recognized on the MRI. On preoperative examination (visit 4) - blood and urine samples will be taken prior to procedure. Visit 5 - the focal treatment will be performed under Spinal regional anasthesia - in the TGH research 1.5T MRI suite. MR guided FLA procedure is similar to MR guided brachytherapy, with fibers and probes inserted trans-perinealy outside the bore of the MR and then the patient is moved inside the bore to verify position before deploying the laser. The treatment is expected to last 1-2 hours, and patients expected to have no pain during the whole procedure. Laser ablation will be monitored using MR thermometry14, 15.An MRI scan will be done immediately after the ablation, as initial assessment for ensuring complete treatment of the target volume, as well as ensuring that treatment does not extend to critical structures.
The size and location of the lesion will be compared to the planned target volume and the proximity of the lesion to the urethra and rectum. If the lesion does not encompass the target volume, and is still a safe distance from either critical structure, FLA may be continued.
On day 1, 7, 30, and 120 following the procedure, patients will be assessed for clinical signs of urinary, rectal, and erectile complications and will complete validated self-assessment tools on these functions. Free/Total PSA will be monitor on visit -1 and after the treatment on day 7, 30 and 120, in order to try to understand the effect of FLA on PSA. Four months after the focal procedure, MRI will be done to assess the ablated lesion, a further 12 cores biopsy, plus 2 cores aimed to the ablated lesion will then be preformed providing MRI excludes rectal abnormalities, to verify the oncological effectiveness of the treatment.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MRI Targeted Focal Laser Thermal Therapy
Princess Margaret Hospital, University Health Network
University Health Network, Toronto
Published on BioPortfolio: 2014-08-27T03:14:57-0400
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Treatment using irradiation with LASER light of low power intensity so that the effects are not due to heat, as in LASER THERAPY. These non-thermal effects are thought to be mediated by a photochemical reaction that alters CELL MEMBRANE PERMEABILITY, leading to increased mRNA synthesis and CELL PROLIFERATION. Low-level laser therapy has been used for a wide variety of conditions, but most frequently for wound healing and pain control.
A technique utilizing a laser coupled to a catheter which is used in the dilatation of occluded blood vessels. This includes laser thermal angioplasty where the laser energy heats up a metal tip, and direct laser angioplasty where the laser energy directly ablates the occlusion. One form of the latter approach uses an EXCIMER LASER which creates microscopically precise cuts without thermal injury. When laser angioplasty is performed in combination with balloon angioplasty it is called laser-assisted balloon angioplasty (ANGIOPLASTY, BALLOON, LASER-ASSISTED).
A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.
Radiotherapy where cytotoxic radionuclides are linked to antibodies in order to deliver toxins directly to tumor targets. Therapy with targeted radiation rather than antibody-targeted toxins (IMMUNOTOXINS) has the advantage that adjacent tumor cells, which lack the appropriate antigenic determinants, can be destroyed by radiation cross-fire. Radioimmunotherapy is sometimes called targeted radiotherapy, but this latter term can also refer to radionuclides linked to non-immune molecules (see RADIOTHERAPY).
Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.
Radiology is the branch of medicine that studies imaging of the body; X-ray (basic, angiography, barium swallows), ultrasound, MRI, CT and PET. These imaging techniques can be used to diagnose, but also to treat a range of conditions, by allowing visuali...
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