A phase III randomized, prospective, multi-center clinical study of High Intensity Focused Ultrasound (HIFU) for the treatment of low risk localized prostate cancer has been initiated in the United States. The objective of the study is to assess the safety and effectiveness of HIFU as compared to cryotherapy. The HIFU treatment is conducted under spinal or general anesthesia to deliver focused energy from an endorectal probe containing ultrasound treatment and imaging transducers. The cryotherapy treatment is conducted by inserting an ultrasonically guided series of needle probes through the perineum (the tissue between the rectum and the scrotum/penis) to deliver extreme cold temperatures to the tissue. Patient diagnosed with low risk localized prostate cancer are being recruited into the study. Candidates for study participation must meet study inclusion/exclusion criteria prior to study enrollment. 

The main study inclusion criteria are¹:

• Male subject 50 years or older
• Organ-confined prostate cancer (localized prostate cancer)
• No previous treatment for prostate cancer.

The main exclusion criteria are¹:

• Any previous treatment for prostate cancer
• Previous surgery or procedure of the prostate (except prostate biopsy) or urethra within the prior one year
• Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease

If you have been diagnosed with low risk, localized prostate cancer, if you meet the inclusion criteria and none of the exclusion criteria listed above, and if you are interested in participating in this study, you can find more information about this clinical study including the complete list of inclusion / exclusion criteria, list of investigational sites participating in the study and study contacts on the US National Institutes of Health web site. For a direct link to the website click here. 

You may also contact:

Devonne Pavlak 678-921-4431 Ext 436 Devonne.Pavlak@HealthTronics.com
Jagruti Vyas 202-546-1262 Ext. 263 jagruti.vyas@gmail.com