Please watch this consent video carefully and completely in order to prepare yourself, family members, and caregivers for the procedure. Do not skip ahead. It is essential that you watch it in its entirety. We want you to be as prepared as possible. This video describes the possible risks connected with performing laser focal therapy for prostate cancer. Should you have any questions or concerns, we strongly encourage you to contact our office prior to your procedure so that we may clarify any pertinent issues. “An educated patient is the best patient.”
To contact the HALO Diagnostics office and procedure location by phone, call (760) 776-8989
The purpose of this is to utilize MR (magnetic resonance) guided laser focal therapy to ablate prostate cancer lesions. MR uses large magnets and radio waves to generate images of organs in the body. The laser uses light to heat a target area to destroy cancerous cells.
The laser systems that will be used have been used for the treatment of brain, bone (spine), thyroid, and liver cancers.
The laser applicator placement will be performed using the Invivo DynaLOC software and DynaTRIM trans-rectal biopsy guidance system. This system is cleared (approved) by the U.S. Food and Drug Administration (FDA) for such uses.
Laser focal therapy of the prostate gland is a minimally invasive alternative to the standard treatment of prostate cancer. It is a targeted procedure that focuses on a single area of the tumor as opposed to whole-gland therapy. For the procedure, a laser applicator is introduced under MRI guidance via the rectum. Once in the gland, a nontherapeutic “test” dose is administered to verify proper placement in the target, then increased while “real-time” temperature change is displayed on a thermal map.
Once the entire area is treated (approximately 2 minutes), the laser is turned off. The number of treatments depends on the size, number, location, and shape of the target lesion(s).
Prior to the procedure, a medication review will be scheduled with your clinician. Any anticoagulant medications must be stopped prior to the procedure as ordered by your treating physician. The procedure cannot be scheduled if you are currently on or have recently taken any anticoagulant medications (“blood thinners”) that may interfere with your ability to clot your blood. The most common of these medications are anticoagulants such as coumadin, Xarelto, Pradaxa, and over-the-counter medications also known as nonsteroidal anti-inflammatory drugs such as Aspirin, Celebrex, Motrin, Ibuprofen, Advil, Aleve, and other pain reliever compounds (whether prescription or over the counter). Review the list of drugs you take carefully as many over-the-counter medications like Alka-Seltzer and Pepto Bismol contain Aspirin. If in doubt check with your clinician. If needed, use Tylenol (acetaminophen) instead.
Prior to the procedure, you must fast for 8 hours. Do not eat any food or consume any liquids during this time. We want to avoid gas or stool in the rectum for your procedure. Upon arrival, you will be provided an enema. Depending on the treatment location, you may also have a urinary catheter inserted prior to your procedure.
You may be given an oral antibiotic which should be taken as directed by our physicians. Most patients will simply receive intravenous antibiotics at the time of the procedure.
You must have a friend or family member come with you to your appointment to drive you home and remain with you overnight. This is extremely important since you will receive conscious sedation. Plan to remain in the area for at least two days after your procedure for observation. If you cannot bring a friend or family member there are local services that can provide you with overnight care the day of your procedure.
Prior to laser focal therapy, the following study procedures will be performed.
The actual procedure typically takes up to 4 hours. You will have a local anesthetic and be given an IV sedative medication before the procedure. You will also receive a regional anesthetic which is injected into both sides of the prostate gland. You will get a urinary catheter placed before your procedure if the tumor is down low in the apex, or afterward to preserve urine flow as the prostate can swell from inflammation. You’ll be placed lying face down on the MRI table. A laser guide will be gently placed in your rectum. Although it is slightly uncomfortable, very few patients believe it is painful. After confirming the precise position of the small laser applicator with MRI, we will then treat the target area(s). The amount of time the laser is on will depend on the decision of the surgeon, your anatomy, and possibly on whether you have had a therapy done in the past.
At the end of the laser treatment, post-treatment MR imaging will be performed.
After the procedure, you might feel a bit sore in the rectal or anal area for a few hours. Patients with hemorrhoids might have discomfort a bit longer. It is very common to see some blood from the rectum, on the stool with the next bowel movement, or on the toilet paper especially that day and rarely the next day. Again, this is more common in patients with hemorrhoids. A small amount of blood in the urine or some discoloration of the urine is also a possibility. You may commonly see blood in your semen (ejaculation) for 1-2 days and sometimes up to 6 weeks. It might be red or just discolor your semen brown.
You are restricted from driving immediately following the treatment. You have no other restrictions after the procedure other than to take it easy that day and not engage in strenuous activity for 4-6 weeks. Have a family member or friend drive you home following the procedure. This is temporary and the duration will depend on the size and location of the treatment(s).
It is recommended that you follow up approximately 5-14 days, 6 months, and 12 months after treatment and as indicated thereafter at our HALO center or any other radiology center. At each follow-up visit, you should undergo the following exams where your insurance will be charged:
At your first post-treatment follow-up visit, you should receive a pelvic ultrasound to evaluate your bladder function.
Additionally, at approximately 6 months post-treatment, you should undergo multiparametric MRI and MR- guided biopsy if indicated. Biopsy samples, if performed, will be sent for evaluation by a pathologist. At one year you should have mp-MRI and surveys. We will need your PSA at each follow-up interval. This is a very important detail.
After approximately one year, you should undergo a multiparametric MRI and submit surveys and questionnaires.
This procedure, regardless of complexity or time, may be associated with unforeseen problems. Problems may be immediate or even quite delayed in presentation. While we have discussed these and possibly others in your consultation, we would like you to have a list so that you may ask questions if you are still concerned. Aside from anesthesia complications, it is important that every patient be made aware of all possible outcomes which may include, but are not limited to:
For those patients, it is important to note that while focal laser therapy may not substantially affect fertility (i.e. prostate cancer lesions located anteriorly within the prostate) making focal laser therapy in patients who wish to preserve fertility preferable compared with other treatment options which are less precise and therefore may compromise fertility, there are, nonetheless, certain situations where prostate cancer focal laser therapy may result in the destruction of one or both ejaculatory ducts which deliver semen for ejaculation and thus significantly reduce or entirely eliminate fertility.
Additionally, focal laser therapy of a prostate cancer lesion may result in retrograde ejaculation (ejaculation into the bladder rather than into the urethra for expulsion) resulting in infertility. Therefore, for those men who may wish to father children following focal laser therapy, we recommend banking sperm PRIOR to focal laser therapy.
This is another reason why post-procedure urinary catheter placement is important. Usually, the problem resolves with time after the swelling goes down. Patients at greater risk are those who already have difficulty urinating before the procedure due to BPH (Benign Prostatic Hyperplasia).
It might be a simple bladder infection that presents with symptoms of burning urination, urinary frequency, and a strong urge to urinate. This will usually resolve in a few days with antibiotics. If the infection enters the bloodstream, you may feel very ill. This type of infection often presents with urinary symptoms and any combination of the following: fevers, shaking, chills, weakness or dizziness, nausea, and vomiting. You may need a short hospitalization for intravenous antibiotics, fluids, and observation. This is more common in diabetics, patients on long-term steroids, or patients with any disorder of the immune system. Lastly, an abscess of the prostate, while quite rare, can develop. This is an infection cavity that may respond to antibiotics alone or need surgical (needle) drainage. It can begin with urinary symptoms but also progress to the symptoms of bloodstream infection. Urinary retention is also possible with an abscess.
The gadolinium contrast agent used with MRIs has known risks. The most common are:
Rarely, serious, life-threatening allergic-type reactions can occur.
If you have symptoms of any of the above, especially those of infection, you must contact HALO Diagnostics immediately or go to the nearest Urgent Care or emergency room.
Your alternatives to this procedure include:
The doctor will discuss these alternatives with you.
Your information may also be given to the U.S. Food and Drug Administration (FDA). It may be given to similar governmental agencies in other countries.
Medical records which identify you and the consent form signed by you may also be looked at and/or copied for research or regulatory purposes by:
Although absolute confidentiality cannot be guaranteed because of the need to give information that identifies you to these parties, we make every effort to anonymize information for all of our patients.
Although currently not considered standard of care for treatment of prostate cancer, Phase II investigational studies have demonstrated treatment efficacy comparable to radical prostatectomy and possibly superior to radiation therapy regarding prostate cancer recurrence rates with superior quality of life metrics (i.e. erectile dysfunction, urinary incontinence, rectal injury) allowing Laser Focal Therapy to move from investigational to translational on the status and ultimately standard of care.
For answers to questions relating to this procedure, or to report a concern, complaint, or injury, or for information regarding laser procedures you may contact:
HALO Diagnostics office: 760-776-8989
Bernadette M. Greenwood MSc., RT(R) (MR) (ARRT):
760-776-8989 x747 (24 hours)
262-269-8764 (24 hours)
If you are experiencing any medical emergency, dial 911 or go to the emergency room or urgent care.
Once I sign the physical Informed Consent Document, I am agreeing to undergo magnetic resonance image-guided transrectally delivered laser-induced interstitial thermal therapy for laser focal therapy of prostate cancer in an outpatient setting.