Halo Diagnostics

MRI-Guided Laser Focal Therapy for Prostate Cancer - Research Patient Informed Consent

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

We are here to support you, please contact us if you have any questions or need assistance of any kind.

You are being asked to take part in this research study at HALO Diagnostics, a private practice directed by Dr. John F. Feller. This consent video explains why this research study is being performed and what your role will be if you choose to participate. This video also describes the possible risks connected with being in this study. You should ask questions about anything that is not clear to you before you decide to participate. You are being asked to take part in this study because you have prostate cancer.

Title:            A Phase II Study to Evaluate Outpatient Magnetic Resonance Image-guided Laser Focal Therapy for Prostate Cancer, a 20-year Survival Study

 Protocol No.:           DMI-LASER-001 | WIRB® Protocol #20140945 | NCT02243033

Sponsor:                   HALO Diagnostics

Investigator:            John F. Feller, MD – HALO Diagnostics: Suite 101, 74785 Hwy 111, Indian Wells, California 92210, United States

Site(s):                      HALO Diagnostics: Suite 101, 74785 Hwy 111, Indian Wells, California 92210, United States

  • Study-related phone numbers:    
  • John F. Feller, MD – 760-776-8989, 760-275-7919 (24 Hours)
  • Bernadette M. Greenwood, BSc., PG Cert., RT(R) – 760-766-2047 (24 hours), 262-269-8764

Purpose  

The purpose of this research study is to continue to investigate the safety and effectiveness of using MR (magnetic resonance) guided focal thermal laser therapy for prostate cancer and to evaluate oncologic control over 20 years. MR uses large magnets to produce pictures of areas/organs inside the body. The laser uses light to heat a target area to try 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. However; this is the first clinical trial in which laser energy is being studied for use in the treatment of prostate cancer with a trans-rectal approach.

The MR-guided biopsies and laser applicator placement will be performed using the Invivo DynaTRIM trans-rectal biopsy guidance system. This system is cleared (approved) by the U.S. Food and Drug Administration (FDA) for such uses.

We do not know whether MR-guided thermal therapy will be as safe or as effective as standard treatment methods.

Our Phase I and interim 8 years of experience in Phase II indicate that oncologic control is achievable in over 75% of research subjects.

About 200 subjects will take part in this research study. The expected length of participation is about 20 years.

Definition  

Laser ablation of the prostate gland is a minimally invasive experimental 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 non-therapeutic “test” dose is administered to verify proper placement in the target, then turned up while the doctor observes activity “real-time” on a thermal map. Once the entire area is treated (1-2 minutes), the laser is turned off. One or more ablations may be performed depending on the size, number, or shape of the target lesion(s).

Preparation  

The procedure cannot be done if you are currently on or have recently taken any anticoagulant medication that may interfere with your ability to clot your blood (“blood thinners”). We will have reviewed all of your current medications with you during the consultation, but please tell us if anything has changed since your previous visit. We need to make sure that your medication is not a blood thinner. The most common of these medications are aspirin and all related pain reliever or anti-inflammatory compounds (whether prescription or over-the-counter).

You will need to fast for 8 hours prior to prostate focal ablation. Do not eat any food or consume any liquids during this time period. We want to avoid gas or stool in the rectum. You will be asked to take two adult fleet enemas. These should be completed 1-2 hours before you arrive for your appointment with our office.

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 to have follow-up imaging.

Procedures  

Baseline Evaluation Procedures  

Prior to laser focal therapy, the following study procedures will be performed.  

  • Medical history and quality-of-life questionnaires.  
  • Blood tests – including but not limited to PSA.  
  • Multiparametric MRI of the prostate – including MRI with contrast (gadolinium).  
  • Estimate of prostate gland volume.  
  • Biopsy (a targeted biopsy should be performed and possibly a systematic biopsy). 

Image-Guided Biopsy and Treatment Procedures

If you continue to meet inclusion criteria and one, two, or three (but not more) MR-guided biopsy positive lesions are identified, you may undergo laser treatment of some of the same target locations. The actual procedure typically takes up to 4 hours. You will have a local anesthetic and be given an IV sedative medication before and during the procedure. You will 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. The amount of time the laser is on will depend on the decision of your radiologist/interventional radiologist/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 done.

Post Procedure  

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 bowl 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 rarely seen but not impossible. You may commonly see blood in your semen (ejaculation) for 1-2 days and sometimes up to 3-4 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. Have a family member or friend drive you home following the procedure. At the discretion of your radiologist/interventional radiologist/surgeon, you may go home with a urinary catheter in place. This is temporary.

 Post-treatment Evaluation  

You will be asked to return 2 days, 6 months, and 12 months after treatment and as indicated thereafter. At each follow-up visit, you will undergo the following:

  • History including recent PSA. (Please mail in at 3 mos.)  
  • Quality-of-life questionnaire scores evaluation. (Please mail in at 3 mos.)  
  • Assessment of any side effects or problems.  
  • mp-MRI of the prostate – including MRI with contrast (gadolinium).  

Two days post-treatment you will receive a pelvic ultrasound to evaluate your bladder. Additionally, at 6 months post-treatment, you will undergo multiparametric MRI and MR- guided biopsy of the treated regions of the prostate even if your mpMRI shows no suspicious areas. Biopsy samples of the treated area will be sent for evaluation by a pathologist. At one year you will have mpMRI and surveys. We need your PSA at each follow-up interval.

After one year, you will undergo multiparametric MRI and submit surveys and questionnaires annually for 20 years to contribute to the evaluation of:

  • Rate of Biochemical Recurrence
  • Rate of Metastatic Disease
  • Date and Cause of Death

Possible Complications of the Procedure  

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:

  • Pain and/or discomfort: You may feel sensations of discomfort or heat after your procedure. Discomfort is rare and may be managed with acetaminophen. 
  • Excessive Bleeding from the Rectum/Anus: It is uncommon to require any treatment and the majority of the time bleeding stops on its own. This is far more common in patients with hemorrhoids or arterial bleeding. In the unusual circumstance that excessive bleeding occurs or a severe infection occurs this may require emergency room care and possible hospitalization. 
  • Infertility: By the time prostate cancer has been diagnosed and requires treatment, fertility status following treatment has become essentially irrelevant as reproductive issues have already been settled by most men. However, for some men who wish to consider fathering more children, fertility status following treatment for prostate cancer may be significant and relevant.  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 of sperm PRIOR to focal laser therapy.  
  • Blood Clots in the Urine: The device can enter the middle of the prostate where the urethra or the neck of the bladder are located and cause blood in the urine. If the bleeding is significant, it can cause clots that can block the urine flow. A urinary catheter will be inserted to avoid this problem.  
  •  It has been our experience that while the catheter might be uncomfortable it helps to avoid possible issues.  
  • Urinary Retention: Even in the absence of bleeding, the prostate can become swollen from the treatment or secondary to infection. 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) 
  • Urinary Tract Infection or Urosepsis: Although you will receive IV antibiotics, it is possible for you to get an infection. 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.  
  • Erectile Dysfunction (ED): Inability to achieve or maintain an erection can occur following this procedure in less than 1% of patients. This condition may be temporary or permanent. A decrease in the volume of seminal fluid is also a possibility. This may result in infertility.  
  • Urinary Incontinence: The ability to voluntarily control urination may be lost in less than 1% of men undergoing this procedure. This may be a temporary or permanent condition.  
  • Tingling/Numbness of the Penis or Scrotal Pain: Some men may feel an urge to urinate during the procedure.  Some feel tingling in their penis or scrotum due to referred pain. Similar to when you hit your funny bone, your fingers may tingle. These sensations generally stop after each 2 minute treatment, and rarely persist after the procedure. These symptoms are self-limiting. 
  • Scrotal pain has also been reported following the procedure. Our multilayered anesthetic techniques help to manage this.  
  • Rectal Fistula: Rarely an abnormal connection between the rectum and the urethra or urinary bladder may develop. This may require surgery for treatment. Our team devised a method to place safety boundaries over important structures like the rectal wall to avoid this serious problem.  
  • Residual Prostate Cancer: Several studies have shown that there is improved survival after ten years following whole-gland definitive therapy (radical prostatectomy, radiation therapy) compared with active surveillance (watchful waiting) for the treatment of prostate cancer confined to the prostate gland. Laser focal therapy has similar rates of recurrence as prostatectomy and radiation without the side effects of incontinence and impotence.  
  • Thermal injury to nearby organs: Injuries due to the heat produced by the laser have not been seen in patients to date; 
  • However, there is a possibility that heat damage could occur if the laser fiber has a crack along its length. We prevent this by visually inspecting every fiber prior to its use to ensure energy is being emitted only from the tip. 
  • Carbonization of laser applicator: This may result in a portion of the applicator being retained inside the prostate or being expelled. 

 

The gadolinium contrast agent used with MRIs has known risks. The most common are:

  • strange tastes;
  • changes in smells;
  • injection site reactions;
  • nausea;
  • generalized feeling of warmth; headache; and

 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 the office of Dr. John F. Feller immediately or go to the nearest Urgent Care or emergency room.

Benefits:

You may or may not directly benefit from participating in this study. Your participation may be beneficial to others by providing information that is useful to our understanding of the procedure and its outcomes in certain men. Each man responds differently, and individual results may vary, but our goal is to achieve durable cancer control while preserving the opportunity for all other treatment options (i.e. surgery, radiation, etc.).

 

Some men have reported improvement in urination following laser focal therapy of their prostate cancer. We believe this is a byproduct of de-bulking the gland with the treatment.

 

Other benefits that we have observed over ten years include:

  • Safer and more precise than other energy sources
  • “Sculpted” therapy with safety boundaries on important structures
  • No general anesthesia
  • Outpatient procedure
  • Minimal “down-time”
  • Low risk of urinary incontinence
  • Low risk of erectile dysfunction/impotence
  • No bowel toxicity

New information:

You will be told about any new information that might change your decision to be in this study.

Compensation for injury: 

If you are injured; the study doctor can provide information about where to obtain treatment.

 If you are injured during the study, you and your insurance company will be charged for the costs of any treatment needed. Insurance companies may not pay for injuries received from a research study. You should check with your insurance company so that you don’t have unexpected expenses.

You don’t waive any rights to seek compensation through the legal system by signing a consent form.

Costs:

The cost for the laser focal therapy treatment is $24,900 which must be paid at the time of service. We do not submit any portion of study-related costs to insurance. Retreatment is $12,450 (50% of the initial cost) for in-field recurrence. Out-of-field will be $24,900.

Payment:

You will not be paid for being in this study.

Benefits 

You may or may not directly benefit from participating in this study. Your participation may be beneficial to others by providing information that is useful to our understanding of the procedure and its outcomes in certain men. Each man responds differently, and individual results may vary, but our goal is to achieve durable cancer control while preserving the opportunity for all other treatment options (i.e. surgery, radiation, etc.).

 

Some men have reported improvement in urination following laser focal therapy of their prostate cancer. We believe this is a byproduct of de-bulking the gland with the treatment.

  • <1% risk of erectile dysfunction, risk of incontinence, and risk of infection 
  • Ambulatory outpatient procedure lasting 4 hours 
  • Rapid recovery: Most patients can return to work the next day 
  • No general anesthesia required 
  • Highly accurate (within 1 millimeter)
  • Does not limit the option to treat with radiation therapy or surgery if needed later 

Confidentiality  

Information from this study will be given to the sponsor. “Sponsor” includes any persons or companies that are contracted by the sponsor to have access to the research information during and after the study.

The 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:

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:  

  • Department of Health and Human Services (DHHS) agencies,  
  • the institution where the research is being done,   
  • the California Cancer Registry, and
  • Western Institutional Review Board® (WIRB®).

Whenever possible, your identifying information will be protected; for example, your name replaced by a study number. Absolute confidentiality cannot be guaranteed because of the need to give information that identifies you to these parties. The results of this research study may be presented at meetings or in publications. Your identity will not be disclosed in those presentations.

Whom to Contact 

For answers to questions relating to this research study, or to report a concern, complaint or research-related injury, or for information regarding study procedures you may contact the project director:

John F. Feller, M.D. 

760-776-8989

760-275-7919 (24 hours) 

Bernadette M. Greenwood, BSc., PG Cert., RT(R)(MR)(ARRT)

760-766-2047 (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.  

If you have questions about your rights as a research subject or if you have questions, concerns, input, or complaints about the research, you may contact:

Western Institutional Review Board® (WIRB®)

1019 39th Avenue SE Suite 120

Puyallup, Washington 98374-2115

Telephone: 1-800-562-4789 or 360-252-2500

E-mail: Help@wirb.com

WIRB is a group of people who perform independent review of research.

WIRB will not be able to answer some study-specific questions, such as questions about appointment times. However, you may contact WIRB if the research staff cannot be reached or if you wish to talk to someone other than the research staff.

By signing the physical Informed Consent document, I agree to participate in a Phase II study to evaluate magnetic resonance image-guided, transrectally delivered laser-induced interstitial thermal therapy for focal ablation of prostate cancer using thermometry in an outpatient setting.