Cyber Knife Center of Miami

CyberKnife vs HIFU

Prostate Cancer Treatments


HIFU also known as High Intensity Focused Ultrasound and CyberKnife Radiation Therapy are both used to treat prostate cancer and are alternatives to surgery or other types of radiation therapy.


What is CyberKnife Radiosurgery for Prostate Cancer?

HIFU also known as High Intensity Focused Ultrasound and CyberKnife Radiation Therapy are both used to treat prostate cancer and are alternatives to surgery or other types of radiation therapy. 

 What You Need to Know About HIFU for Prostate Cancer                                                                   


· Not FDA Approved in U.S. to Treat Prostate Cancer - ONLY FDA Approved for Prostate Tissue Ablation 

· Touted as Non-invasive, however it is Minimally Invasive

· Requires Anesthesia

· Not Covered by Most Insurance Companies

· No Long Term Studies to Determine Safety and Effectiveness

HIFU is NOT FDA approved to treat prostate cancer. The Center for Devices and Radiological Health at the FDA reports that HIFU was approved recently for prostate tissue ablation (to destroy tissue cells of the prostate), it has never been approved in the U.S. to treat prostate cancer. 

How the HIFU Procedure Works 

HIFU is considered a minimally invasive procedure for the treatment of low-risk, localized prostate cancer and for prostate cancer recurrence in the prostate gland. HIFU is an option for men who are not candidates for open surgery (prostatectomy) or don’t want to undergo surgery or radiation therapy.

HIFU uses high-intensity sound waves to heat and destroy cancer cells. It is not indicated for cancer that has spread (metastasized) beyond the prostate.  

Here’s what happens: At the start of the HIFU procedure, a catheter is inserted through the penis into the bladder to catch urine during the procedure and remains in place for 1 to 3 weeks after surgery. 

Then during the procedure an ultrasound probe is inserted into the rectum and directs heated sound waves through the walls of the rectum to destroy cancer cells. With the use of MRI or ultrasound imaging, the sound waves are aimed toward the cancer cells, heating up to temperatures as high as 90 degrees to ablate the targeted cells. 

HIFU is a 3 hour procedure performed under anesthesia with an additional 3 hours in recovery. 
Pain medication and antibiotics are prescribed after surgery and up to 1 week of downtime is required after the procedure.
Potential Side Effects of HIFU Affect Each Man Differently

Potential side effects include:

Erectile dysfunction – Occurs in nearly all cases immediately after surgery. In extreme circumstances, ED can last 18 to 24 months or longer

Urinary incontinence
 – Most men may experience some urine leakage for several weeks following surgery, but the condition typically resolves itself within a few months

Ejaculatory dysfunction - Occurs in all men

Retrograde ejaculation - Develops in 40 to 90 percent of men

Orgasmic issues - Occurs in about 50% of cases

Penis shrinkage - Frequent occurrence that can worsen over time

Nocturnal and morning erections - Men typically lose these erections immediately following surgery, although they do return over time 

Blood or tissue in urine – It is typical to see some blood in your urine while the catheter is in place. You may also see some small pieces of prostate tissue in your urine for at least six to eight weeks following the procedure 

Symptoms include:

· Urinary frequency and burning
· Rectal wall injury from probe
· Rectal incontinence, burning, and bleeding
· Prostate infection

Rectal fistula – Very rarely, HIFU can cause a hole between the rectum and the urethra (the urinary tract). Signs of a possible rectal fistula include:

  • Urine coming out of your rectum
  • Pain in your pelvis or rectum
  • Bowel contents in your urine
  • Air bubbles in your urine

 You’re more likely to get side effects if you have had more than one HIFU treatment or if you’ve had other types of prostate cancer treatments prior to HIFU. HIFU risks are increased each time the procedure is performed.

If you have an enlarged prostate you are not a candidate for this procedure.

HIFU is Often NOT Covered by Insurance 

Medicare covers the actual operational costs of an approved facility where the procedure takes place however the patient is still responsible for the following:
· The time of the physician who performs the HIFU procedure (and the time of any and all associated clinical support staff)
· The time of the anesthesiologist who administers anesthesia 
· Any and all follow-up patient care and support services post-treatment 

FDA’s Report on the Effectiveness and Safety of HIFU Concluded:

• There are “no HIFU effectiveness data relevant to clinical decision-making such as overall survival or prostate-cancer-specific survival in the US.”
• Long-term effectiveness data from outside the US are sparse and outcomes are variable.
• There are “no patient preference data on HIFU treatment in men with prostate cancer.”

When considering HIFU as a treatment strategy for prostate cancer you should seek out a qualified professional who has performed a significant number of the procedures.



 


What is HIFU Treatment for Prostate Cancer?

HIFU also known as High Intensity Focused Ultrasound and CyberKnife Radiation Therapy are both used to treat prostate cancer and are alternatives to surgery or other types of radiation therapy. 

 What You Need to Know About HIFU for Prostate Cancer       
                                                           


· Not FDA Approved in U.S. to Treat Prostate Cancer - ONLY FDA Approved for Prostate Tissue Ablation 

· Touted as Non-invasive, however it is Minimally Invasive

· Requires Anesthesia

· Not Covered by Most Insurance Companies

· No Long Term Studies to Determine Safety and Effectiveness

HIFU is NOT FDA approved to treat prostate cancer. The Center for Devices and Radiological Health at the FDA reports that HIFU was approved recently for prostate tissue ablation (to destroy tissue cells of the prostate), it has never been approved in the U.S. to treat prostate cancer. 

How the HIFU Procedure Works 

HIFU is considered a minimally invasive procedure for the treatment of low-risk, localized prostate cancer and for prostate cancer recurrence in the prostate gland. HIFU is an option for men who are not candidates for open surgery (prostatectomy) or don’t want to undergo surgery or radiation therapy.

HIFU uses high-intensity sound waves to heat and destroy cancer cells. It is not indicated for cancer that has spread (metastasized) beyond the prostate.  

Here’s what happens: At the start of the HIFU procedure, a catheter is inserted through the penis into the bladder to catch urine during the procedure and remains in place for 1 to 3 weeks after surgery. 

Then during the procedure an ultrasound probe is inserted into the rectum and directs heated sound waves through the walls of the rectum to destroy cancer cells. With the use of MRI or ultrasound imaging, the sound waves are aimed toward the cancer cells, heating up to temperatures as high as 90 degrees to ablate the targeted cells. 

HIFU is a 3 hour procedure performed under anesthesia with an additional 3 hours in recovery. 
Pain medication and antibiotics are prescribed after surgery and up to 1 week of downtime is required after the procedure.
Potential Side Effects of HIFU Affect Each Man Differently

Potential side effects include:

Erectile dysfunction – Occurs in nearly all cases immediately after surgery. In extreme circumstances, ED can last 18 to 24 months or longer

Urinary incontinence
 – Most men may experience some urine leakage for several weeks following surgery, but the condition typically resolves itself within a few months

Ejaculatory dysfunction - Occurs in all men

Retrograde ejaculation - Develops in 40 to 90 percent of men

Orgasmic issues - Occurs in about 50% of cases

Penis shrinkage - Frequent occurrence that can worsen over time

Nocturnal and morning erections - Men typically lose these erections immediately following surgery, although they do return over time 

Blood or tissue in urine – It is typical to see some blood in your urine while the catheter is in place. You may also see some small pieces of prostate tissue in your urine for at least six to eight weeks following the procedure 

Symptoms include:

· Urinary frequency and burning
· Rectal wall injury from probe
· Rectal incontinence, burning, and bleeding
· Prostate infection

Rectal fistula – Very rarely, HIFU can cause a hole between the rectum and the urethra (the urinary tract). Signs of a possible rectal fistula include:

  • Urine coming out of your rectum
  • Pain in your pelvis or rectum
  • Bowel contents in your urine
  • Air bubbles in your urine

 You’re more likely to get side effects if you have had more than one HIFU treatment or if you’ve had other types of prostate cancer treatments prior to HIFU. HIFU risks are increased each time the procedure is performed.

If you have an enlarged prostate you are not a candidate for this procedure.

HIFU is Often NOT Covered by Insurance 

Medicare covers the actual operational costs of an approved facility where the procedure takes place however the patient is still responsible for the following:
· The time of the physician who performs the HIFU procedure (and the time of any and all associated clinical support staff)
· The time of the anesthesiologist who administers anesthesia 
· Any and all follow-up patient care and support services post-treatment 

FDA’s Report on the Effectiveness and Safety of HIFU Concluded:

• There are “no HIFU effectiveness data relevant to clinical decision-making such as overall survival or prostate-cancer-specific survival in the US.”
• Long-term effectiveness data from outside the US are sparse and outcomes are variable.
• There are “no patient preference data on HIFU treatment in men with prostate cancer.”

When considering HIFU as a treatment strategy for prostate cancer you should seek out a qualified professional who has performed a significant number of the procedures.




 

 

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