Clinical Trials: TACT >TACT FAQs

Participating in a clinical trial is a big decision. We encourage you to research your options and prepare a list of questions to discuss with your doctor. We want to ensure you have all the information you need to decide with your family members, if participating in a clinical trial is right for you.

TULSA Questions

What is TULSA?

TULSA, which stands for Transurethral Ultrasound Ablation, is a unique method of ablating prostate tissue.  A minimally invasive ultrasound probe is inserted in the urethra.  This enables the heating of the prostate from the urethra towards the prostate boundary, eliminating the need to have energy travel through the rectum and other adjacent critical structures to reach the prostate.  The ultrasound heats the tissue, creates cell death and ablates the prostate.

Another important element of this procedure is that it takes place inside an MRI machine.  Real-time MRI scans provide clinicians with accurate prostate imaging and enable them to personalize the treatment plan to each prostate shape and size. Real-time MRI guidance during the prostate ablation ensures that the ultrasound thermal energy is delivered precisely to the targeted tissue.

What is localized or organ confined prostate cancer?

Localized or organ confined prostate cancer means that the cancer is within the prostate gland and hasn’t spread outside the prostate or anywhere else in the body.

Why treat the whole gland?

Prostate cancer is a multifocal disease. Multifocal means more than one tumour is present within the prostate gland. Large tumours can be located easily but small ones are not easily detected. If the whole gland can be heated accurately and precisely, then the uncertainty in finding tumour is addressed.

Will I preserve my erectile function after TULSA treatment?

It depends on the stage and location of the disease. TULSA accurately delivers heat to the prescribed treatment plan.

The prescribed treatment plan means that the treating physician will draw the boundary which needs to be heated and ablated. TULSA will precisely ablate all the tissue within that boundary with ± 1.3 mm precision.

TULSA-PRO® Phase 1 results demonstrated a favorable safety profile including erectile dysfunction. Please ask your urologist to review your diagnosis and treatment plan with you so you can make an informed decision.

What questions should I ask my doctor about TULSA?

  • How accurate is my disease stage?
  • Is my disease visible on MRI?
  • Where is my disease located within my prostate?
  • How will the TULSA procedure address my disease?
  • If the tumour is not close to my neuro vascular bundles, can I preserve my erectile function after TULSA?
  • Will my urinary function be preserved after TULSA?

TACT Trial Questions

Who can join this study?

Men between 45 and 80 years old with low to intermediate risk prostate cancer that is confined to their prostate gland.  For full trial eligibility details, visit clinicaltrials.gov  (ClinicalTrials.gov Identifier: NCT02766543)

Are there any costs for participating in the study?

The study will pay for research-related items and/or services that are provided only because you are participating in the study.

How long does the procedure take?

This is a one day procedure which means the treatment is only delivered once. The procedure is completed in a single session within a few hours. In addition to the procedure day, you will be required to see the doctor for follow-up visits.

How often will I be seen by my doctor?

Your participation in this study will last up to 5 years. Following initial evaluation (screening) phase, you will undergo treatment delivery with the TULSA-PRO® device. All treated patients will complete follow-up visits, the first between 1 to 4 weeks after treatment for catheter removal, and then at 1, 3, 6, 12, 24, 36, 48 and 60 months post-treatment.

Are there any risks?

As with all medical procedures, there are risks associated with TULSA-PRO®. Risks related to the technology are closely watched by the regulatory authorities to ensure patient risks are mitigated. Phase 1 results demonstrated a well-tolerated side effect profile with minor or no impact on urinary, erectile, and bowel function at 12 months1. Please consult with your doctor who will be able to outline all the risks associated with TULSA-PRO® .

There is also a potential risk of remaining prostate cancer after the procedure. Treatment with TULSA-PRO® does not prevent you from undergoing standard of care therapies for your prostate cancer in the future, such as radical prostatectomy (surgery) or radiation therapy.

1 Chin et al. European Urology. 2017