Focal Laser Ablation: The Casit Approach
Focal laser ablation achieves oncologic control by inducing hyperthermic conditions throughout the target lesion. Successful treatment requires accurate guidance of the laser fiber to the target lesion as well as real-time monitoring. Both of these tasks can be achieved with magnetic resonance imaging, however, this method is time consuming and expensive. We are developing an alternative approach in which ultrasound and interstitial probes are used for laser fiber guidance and treatment monitoring respectively .
Figure 2: A Setup during focal laser ablation. Ultrasound is used to guide a laser fiber to a target lesion with the resulting ablation monitored via four interstitial thermal probes. B Thermal data acquired by the interstitial thermal probes for two laser activations at different locations in the prostate. Note that the probe monitoring the laser tip exceeds 60°C while safety probes outside the target treatment zone remain relatively cool. C The treated tissue appears as a dark region on post-operative MRI. The location of each probe is indicated with the probe at the laser tip lying inside the treatment zone and all safety probes positioned in untreated tissue.
This project is a multi-disciplinary effort involving urologists, radiologists, pathologists, engineers and industry collaborators. The video below outlines our journey which started with the development of targeted biopsy for prostate cancer diagnosis.
More About This Trial
For some men, radiotherapy or surgery to remove the prostate gland is not a suitable treatment, or they dont want to have the side effects that these treatments can cause. For these men, monitoring the cancer until it starts to grow may be an option. This is called active surveillance.
Another option is to treat only the area of the prostate that contains cancer. This is called focal therapy. Radiofrequency ablation is a type of focal therapy.
Doctors will use an MRI scan to see what areas of cancer they think are likely to grow and cause problems. They describe these areas of cancer as being clinically significant. In this study, doctors will only treat clinically significant areas of cancer. But they will watch the untreated areas carefully to check they are not getting worse.
The aims of this study are to
- See how well radiofrequency ablation treatment using Encage works for men with localised prostate cancer
- Learn more about the side effects of radiofrequency ablation using Encage
Drugs That Stop Androgens From Working
For most prostate cancer cells to grow, androgens have to attach to a protein in the prostate cancer cell called an androgen receptor. Anti-androgens are drugs that also connect to these receptors, keeping the androgens from causing tumor growth. Anti-androgens are also sometimes called androgen receptor antagonists.
Drugs of this type include:
They are taken daily as pills.
In the United States, anti-androgens are not often used by themselves:
- An anti-androgen may be added to treatment if orchiectomy or an LHRH agonist or antagonist is no longer working by itself.
- An anti-androgen is also sometimes given for a few weeks when an LHRH agonist is first started to prevent a tumor flare.
- An anti-androgen can also be combined with orchiectomy or an LHRH agonist as first-line hormone therapy. This is called combined androgen blockade . There is still some debate as to whether CAB is more effective in this setting than using orchiectomy or an LHRH agonist alone. If there is a benefit, it appears to be small.
- In some men, if an anti-androgen is no longer working, simply stopping the anti-androgen can cause the cancer to stop growing for a short time. This is called the anti-androgen withdrawal effect, although they are not sure why it happens.
Enzalutamide , apalutamide and darolutamide are newer types of anti-androgens.
These drugs are taken as pills each day.
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Laser Focal Therapy: What To Expect
You will receive both email and phone contact information for our medical team so that you can always reach us. In addition, we conduct a pre-operative consultation prior to the procedure, we meet the day of the procedure, and will see you frequently in follow-up.
Our team will have collected and reviewed your medical records to evaluate you for inclusion and suitability. Our surgical team will have discussed your case during Tumor Board and conducted a surgical plan based on size, number, shape and location of ablation areas. Prior to the procedure, we will review the Informed Consent Document with you to ensure you understand every aspect of the procedure. We will discuss the risk, benefits, and paperwork of the procedure.
The day of the procedure, our nurse will place an intravenous catheter in your arm so that she/he can administer IV antibiotics, pain medications and fluids . Should other medications be necessary, they will be administered through this IV as well.
You may have a urinary catheter placed so that we can provide cooled urethral saline through Continuous Bladder Irrigation protection. This catheter remains in place depending on the size, shape, and location of treatment. Our urologist will perform the insertion and removal.
Patients will return home or to their hotel room after at least two hours in the recovery room that same day. They must be accompanied by a family member or care giver as driving is not permitted.
What Can Be Expected After Treatment Using Focal Therapy
Patients treated with focal therapy still need to be actively monitored afterwards. This includes watching for disease that may have gone undetected, has returned, is spreading, or is appearing for the first time. If follow-up tests show that some of the treated cancer still remains, additional ablation, surgery, or radiation may be needed.
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This Prostate Cancer Awareness Month Help Change The Future Of Prostate Cancer
1 in 9 men will be diagnosed with prostate cancer in their lifetime. This September alone, during Prostate Cancer Awareness Month, it is estimated that more than 1,900 Canadian lives will be forever changed by the words, You have prostate cancer. But people affected by prostate cancer dont have to face their diagnosis alone. Together, we can create a world where no one fears prostate cancer by funding Canadas most promising prostate cancer research and life-changing support programs.This month, there are many ways to get involved and make a difference in the lives of those affected by the disease.
A Study Of Radiofrequency Ablation To Treat Cancer In The Prostate Gland
Please note – this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at treating prostate cancer with radiofrequency ablation using a new device called Encage. Radiofrequency is a type of electrical energy. Ablation means destroying completely. The electrical energy heats up the tumour and kills the cancer cells. You have RFA through a probe that goes through your skin into the cancer.
If prostate cancer has not spread outside the prostate gland it is called localised prostate cancer. In this situation, there are different treatments that men can have, such as surgery or radiotherapy. But treatment to the whole prostate gland often causes side effects such as problems getting an erection, urinary problems, diarrhoea and pain or bleeding from the back passage.
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Possible Side Effects Of Cryotherapy
Side effects from cryotherapy tend to be worse if it is done in men who have already had radiation therapy, compared to men who have it as the first form of treatment.
Most men have blood in their urine for a day or two after the procedure, as well as soreness in the area where the needles were placed. Swelling of the penis or scrotum is also common.
Freezing might also affect the bladder and rectum, which can lead to pain, burning sensations, and the need to empty the bladder and bowels often. Most men recover normal bowel and bladder function over time.
Freezing often damages the nerves near the prostate that control erections. Erectile dysfunction is more common after cryotherapy than after radical prostatectomy. For information on coping with erection problems and other sexuality issues, see Sexuality for the Man With Cancer.
Urinary incontinence is rare in men who have cryotherapy as their first treatment for prostate cancer, but it is more common in men who have already had radiation therapy.
After cryotherapy, less than 1% of men develop a fistula between the rectum and bladder. This rare but serious problem can allow urine to leak into the rectum and often requires surgery to repair.
Follow Your Healthcare Providers Instructions For Taking Aspirin
If you take aspirin or a medication that contains aspirin, you may need to change your dose or stop taking it 7 days before your procedure. Aspirin can cause bleeding.
Follow your healthcare providers instructions. Dont stop taking aspirin unless they tell you to. For more information, read the resource Common Medications Containing Aspirin, Other Nonsteroidal Anti-inflammatory Drugs , or Vitamin E.
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Pros And Cons Of Focal Therapy For Localised Prostate Cancer
1Section of Urology and Andrology, Department of Medical-Surgical Specialties and Public Health, Policlinico Santa Maria della Misericordia Sant’Andrea delle Fratte Perugia, University of Perugia, 06122 Perugia, Italy
In prostate cancer, an interesting and intriguing option to overcome the risks of whole-gland treatment is focal therapy, with the aim of eradicating known cancer foci and reducing collateral damages to the structures essential for maintaining normal urinary and sexual function. Ablation of all known lesions would favorably alter the natural history of the cancer without impacting health-related quality of life and allows for safe retreatment with repeated focal therapy or whole-gland approaches if necessary. Our objective is to reassess the possibilities and criticisms of such procedure: the rationale for focal therapy and the enthusiasm come from the success of conservative approaches in treating other malignancies and in the high incidence of overtreatment introduced by prostate cancer screening programs. One of the challenges in applying such an approach to the treatment of prostate cancer is the multifocal nature of the disease and current difficulties in accurate tumor mapmaking.
The new goal of future intervention in the treatment of prostate cancer is the Trifecta concept : it means being cured, continent and potent this is the mainstay of minimally invasive therapy such as focal ablation.
Hormone Therapy For Prostate Cancer
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Hormone therapy is also called androgen suppression therapy. The goal is to reduce levels of male hormones, called androgens, in the body, or to stop them from fueling prostate cancer cells.
Androgens stimulate prostate cancer cells to grow. The main androgens in the body are testosterone and dihydrotestosterone . Most androgen is made by the testicles, but the adrenal glands as well as the prostate cancer itself, can also make a fair amount. Lowering androgen levels or stopping them from getting into prostate cancer cells often makes prostate cancers shrink or grow more slowly for a time. But hormone therapy alone does not cure prostate cancer.
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Quality Of Life Is An Important Endpoint
It is important to provide realistic expectations for men considering RP. Although RP is the best curative option for localized prostate cancer, disease recurrence does occur. Epstein and colleagues reported that the 5-year probability of biochemical recurrence following RP for men with biopsy GGG 1, 2, 3, 4, and 5 is approximately 4%, 12%, 37%, 52%, and 74%, respectively. Furthermore, RP is not without risk of long-term erectile and urinary morbidity. Haglind and colleagues reported on functional outcomes 1 year following over 2000 open and robotic RP performed in Sweden. The rates of incontinence defined by using two or more pads a day was 20% and 21% following open and robotic RP, respectively. The likelihood of an International Index of Erectile Function score decreasing to < 17 was 81% and 77% following open and robotic RP, respectively. Barry and colleagues reported similar results based on pre-operative and post-operative survey of RPs performed in the US Medicare population. Donovan and colleagues recently reported on patient-reported quality-of-life measures to compare functional outcomes between AS, RP, and RT cohorts as part of the ProtecT trial. As expected, men randomized to RP had greater compromise of urinary and erectile function as compared with AS or RT at all time points but had less bowel-related morbidity than the RT cohort.
Mri/mrftb/sb Rarely Misses Significant Disease
The selection of candidates for FA should include a high-quality, multi-parametric MRI , MR-targeted biopsy of the MRI lesion confirming cancer, and contralateral SB showing GGG 1 disease. We identified 59 men who fulfilled our selection criteria for FA who underwent RP at our institution. MRI, MRFTB, and SB were performed on all candidates prior to RP. The surgical specimens were step sectioned and all cancers were identified and mapped. The presence of any Gleason pattern 4 disease outside two hypothetical ablation zones was ascertained. If these men underwent FA with a planned ablation template of MR lesion +10-mm margin or hemiablation, the likelihood of leaving any contralateral Gleason pattern 4 disease was 23% and 19%, respectively. The linear length of Gleason pattern 4 was always less than 1 mm. Therefore, only very low volume Gleason pattern 4 would have been untreated in both FA templates. Some experts have advocated AS for selected cases of Gleason pattern 4 disease., Our study demonstrates that all men undergoing FA must be followed for pre-existing and developing significant disease that may manifest outside the ablation zone.
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Who Are Good Candidates For Focal Therapy
When focal therapy for prostate cancer first began to be used in about 2007, it was only as an alternative to active surveillance in very low-risk patients. Since then, the use of focal therapy has expanded to include those with favorable intermediate risk disease . The best candidates have a prostate gland of about 40cc in size or a tumor in the lower half of a larger gland, a single visible tumor on MRI, and the absence of cancer elsewhere in the gland .
In each case, the doctor will consider the patients general health and mental outlook, the size and location of the tumors present, and their chances of spreading more. Use of tests such as MRI, ultrasound, and biopsy can help decide if a patient will benefit more from focal therapy or from traditional treatments.
We Can Deliver Ablative Energy To Predefined Targets
Oncological control following FA has not been adequately investigated and represents a significant limitation when counseling men considering this treatment. There are many energy sources investigated for FA of the prostate. Most in-field biopsies following FA show no significant cancer within a year of treatment, suggesting ablative energy is being effectively delivered to a designated target., Whether untreated disease within or beyond the ablation zone will become life threatening over time requires further investigation.
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What Are Male Sex Hormones
Androgens are required for normal growth and function of the prostate, a gland in the male reproductive system that helps make semen. Androgens are also necessary for prostate cancers to grow. Androgens promote the growth of both normal and cancerous prostate cells by binding to and activating the androgen receptor, a protein that is expressed in prostate cells . Once activated, the androgen receptor stimulates the expression of specific genes that cause prostate cells to grow .
Almost all testosterone is produced in the testicles a small amount is produced by the adrenal glands. Although prostate cells do not normally make testosterone, some prostate cancer cells acquire the ability to do so .
Selecting Candidates For Focal Ablation
There is no consensus how to optimally stratify men with localized prostate cancer to RP, RT, FA, or AS. A consensus statement recommends that all candidates for FA should undergo an MRI, MRFTB, and SB., An alternative would be to perform transperineal saturation biopsy to map the disease. We offer FA to men with a single MRI lesion without gross extracapsular extension who have high-volume GGG 1 or any volume GGG 2-3 and very select cases of GGG 4. Generally, we do not exclude cases with low-volume contralateral GGG 4 .
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Fusion Guided Focal Laser Ablation Of Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
|Recruitment Status : Enrolling by invitationFirst Posted : May 3, 2016Last Update Posted : July 14, 2021
- Study Details
Prostate cancer is the most common non-skin cancer in U.S. men. Treatments for early or less aggressive disease are limited. Researchers want to test a device that destroys cancerous tissue with laser energy. They want to see if using it with ultrasound is more comfortable than using it with magnetic resonance imaging .
To test a cooled laser applicator system to treat prostate cancer lesions. To see if ultrasound imaging is a practical and feasible treatment with laser ablation for focal prostate cancer treatment.
Men at least 18 years old with prostate cancer seen on MRI that has not spread in the body.
Participants will be screened with standard cancer care tests. These can include physical exam, lab tests, and MRI. For the MRI, they lie in a machine that takes pictures. Participants will have a prostate biopsy. Needle samples will be taken from 12 places in the prostate. This will be guided by MRI and ultrasound, which is obtained through a coil in the rectum.
The cooling catheter will be removed. A different catheter will be put in the urethra to keep the bladder emptied.