Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jonsson Comprehensive Cancer Center
Age
40–85
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Subjects with initial presentation of organ confined prostate cancer (clinical stage ≤ T2b)
* Negative metastatic workup with bone scan and CT abdomen/pelvis, within 6 months of study treatment, if indicated by PSA \>10
* Age 40 years to 85 years of age
* Multi-parametric MRI at UCLA within 6 months of study treatment, demonstrating a
* Region of interest (ROI) of MRI suspicion level 3 or higher
* ROI located proximal to the external sphincter by a margin of at least 2 cm
* Transrectal ultrasound-guided biopsy with ≥ 10 systematic biopsy cores and ≥ 2 MRI-ultrasound fusion targeted biopsy cores from above MRI-derived ROI
* Histologically-confirmed adenocarcinoma from targeted biopsy cores (≥ 2 cores)
* Overall Gleason score not to exceed 3+4
* Subjects desire focal therapy and declined conventional treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)
* Signed informed consent for the LITT treatment through the 12 month follow up visit
You may not be if
Any significant cancer outside of MRI target (ROI) area, defined as Gleason score \> 3+4
\< 10 years life expectancy
American Society of Anesthesiologists (ASA) criteria of IV or higher
Unfit for conscious sedation anesthesia
Active bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, INR or platelet count (as determined by institutional lab parameters) at the time of screening
Use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped for a window of at least 7 days peri-procedure
Active urinary tract infection
Prostate abscess, chronic or acute prostatitis, or neurogenic bladder
Any prior treatment for prostate cancer
* Radical prostatectomy
* Radiation therapy (external beam or brachytherapy)
* Cryotherapy
* High intensity focused ultrasound treatment
* Photodynamic therapy
* Androgen deprivation therapy
Prior prostate, bladder neck, or urethral stricture surgery
* Any prostate debulking procedure, including: transurethral resection of prostate, photovaporization, or electrovaporization
* Transurethral incision of bladder neck
* Urethral stricture dilation or reconstruction
Any current 5-alpha reductase inhibitors (history of use ≥ 6 months prior to MRI is acceptable)
Prior significant rectal surgery (hemorrhoidectomy is acceptable)
Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device
History of inflammatory bowel disease
Urinary tract or rectal fistula
Any contraindication to MRI (contrast allergy severe claustrophobia, MRI-incompatible prosthesis)
