MR Image Guided Therapy in Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01377753|
Recruitment Status : Completed
First Posted : June 21, 2011
Last Update Posted : March 24, 2021
- One way to treat prostate cancer is to use a laser to direct extreme heat to a small area of the prostate. The heat destroys tumor cells but does not affect healthy tissue. Doctors want to see if magnetic resonance imaging (MRI) can be used to improve this treatment. MRI will be used to help locate tumor cells and guide the laser during surgery. However, MRI-guided laser therapy has not been used to treat many people with prostate cancer. More studies are needed to see whether it can destroy tumor cells permanently.
- To test the safety and effectiveness of treating prostate tumors with laser therapy guided by magnetic resonance imaging.
- Men at least 18 years of age who have prostate cancer that can be seen with an MRI and has not spread to other parts of the body.
- Participants will be screened with a physical exam and medical history. They will also have blood tests and imaging studies, and will complete questionnaires about their health.
- Participants will have the MRI-guided laser treatment in the hospital. The doctor will use the MRI to control how much energy is delivered by the laser and how much tissue is destroyed. The entire procedure usually takes from 1.5 to 3 hours.
- After the treatment, participants will have a catheter put in to keep the bladder emptied. The catheter will stay in for 1 to 7 days. Drugs to prevent infection and bladder spasms will be given. Participants will leave the hospital once they are well enough to go home.
- Participants will have followup visits 3, 6, 9, 12, 18, 24, and 36 months after the therapy. They will have physical exams, and blood and urine tests. They will also answer questionnaires. Participants will have MRI scans 6, 12, 24, and 36 months after the therapy. They will have a prostate biopsy to see if there is any tumor every 12 months for the first 2 years. Another biopsy may be done in the third year.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Prostatic Neoplasms||Device: Visualase Thermal Therapy System||Phase 2|
- Pilot study is designed to evaluate the safety and feasibility of thermal laser ablation of focal prostate tumors.
- Prostate cancer is relatively slow growing, with doubling times for local tumors estimated at 2 to 4 years.
- Some prostate cancers prove to be small, low grade, and noninvasive and they appear to pose little risk to the life or health of the host. Recent patient series suggest that 20% to 30% of men undergoing radical prostatectomy have pathologic features in the radical prostatectomy specimen consistent with an insignificant or indolent cancer which poses little threat to life or health.
- We propose that patients with low volume and low grade disease can be best served with focal ablation of the visible prostate cancer without the side effects of urinary incontinence and erectile dysfunction associated with radiation therapy or radical surgery.
-To determine feasibility and safety of magnetic resonance image-guided focal laser ablation of biopsy confirmed and MR visible prostate cancer.
- Greater than 18 years of age
- Organ confined prostate cancer, observed on MR, and confirmed by Transrectal biopsy
- Preoperative workup as dictated by the NCCN.org prostate cancer guidelines
- PSA < 15 ng or PSA density < 0.15 ng/ml in patients with a PSA > 15 ng
- Pilot study, testing feasibility, safety and tolerability of thermal ablation of focal prostate cancer
- It is anticipated that 15 patients will be accrued for this study
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MR Image Guided Focal Therapy in Prostate Cancer|
|Actual Study Start Date :||August 12, 2011|
|Actual Primary Completion Date :||January 1, 2017|
|Actual Study Completion Date :||July 31, 2018|
Eligible subjects will undergo MRthermal image guided laser ablation of all biopsy proven areas of prostate cancer using one or multiple laser probes during a single procedure lasting approximately two hours in duration.
Device: Visualase Thermal Therapy System
Used for performing Laser Induced Thermal Therapy to destroy malignant or unwanted tissue by delivering laser energy sufficient to cause coagulation and necrosis of the tissue.
- To determine feasibility and safety of magnetic resonance image-guided focal laser ablation of biopsy confirmed and MR visible prostate cancer. [ Time Frame: 3 years ]Decrease of enhancement on MP MRI at various timepoints,Follow up systematic core biopsy of the prostate at 1, 2, and 3 (optional) years showing no evidence of invasive prostate cancer in the region of laser ablation.Follow up DRE and physical exam at 3, 6, 12, 18, 24 months and yearly for 3 years. This should show no palpable disease, if disease is detected then further workup with one of the above mentioned tests will be performed,PSADT
- tolerability of treatment [ Time Frame: 3 years ]evaluate tolerability of treatment
- outcome of laser ablation [ Time Frame: 3 years ]Determine outcome of laser ablation for treatment of prostate cancer using serial PSA, PSA density, changes in imaging, IPSS, and SHIM
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377753
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Peter A Pinto, M.D.||National Cancer Institute (NCI)|