An interventional study of Radical Prostatectomy and TULSA Procedure in Prostate Cancer and Prostate Adenocarcinoma, sponsored by Profound Medical Inc.. Active, not recruiting at 22 sites in 3 countries. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by Profound Medical Inc. · Not applicable, Interventional, and Treatment
Men with localized, intermediate risk prostate cancer will be randomized to undergo either radical prostatectomy or the TULSA procedure, with a follow-up of 10 years in this multi-centered randomized control trial. This study will determine whether the TULSA procedure is as effective and more safe compared to radical prostatectomy.
The typical standard of care for patients with localized, intermediate risk prostate cancer is radical prostatectomy, which involves the surgical removal of the prostate. Although radical prostatectomy is effective in terms of controlling the cancer, it may leave men with significant long-term effects in urinary, sexual function like erectile dysfunction and/or incontinence (loss of bladder control), thus reducing quality of life. Preservation of continence (ability to control your bladder) and potency (ability to achieve erection and/or ejaculation) may be significant concerns for men.
Targeted ablation of localized prostate cancer using MRI-guided technology is becoming a favorable option for many men who wish to have their cancer treated but do not wish to compromise their urinary and sexual functions. The TULSA Procedure is a new, minimally-invasive technique that uses real-time MRI-guided technology to guide the delivery of high-energy ultrasound to precisely, and in a customized fashion specific to you, heat and kill the prostate cancer tissue while protecting important surrounding body parts that are important for preserving urinary and sexual function. Minimally invasive here means that the procedure is performed through natural openings in your body (the urethra) instead of creating larger openings like traditional surgery or minimally invasive surgery.
The purpose of this research study is to:
About 201 subjects will participate in this study with 67 randomly assigned to the radical prostatectomy group and 134 randomly assigned to the TULSA procedure group. Patients will have a 1 in 3 chance of being assigned to the radical prostatectomy group and a 2 in 3 chance of being assigned to the TULSA group. Following treatment, patients will be followed up for 10 years.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's planned enrollment of 201 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Profound Medical Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this group will undergo Radical prostatectomy. There will be about 67 people in this group.
Device: Radical Prostatectomy
Patients in this group will undergo TULSA Procedure. There will be about 134 people in this group.
Device: TULSA Procedure
If you are in this group, you will get the standard of care treatment used to treat this type of cancer: radical prostatectomy. You will undergo this procedure as per standard clinical practice. A radical prostatectomy is a surgical procedure that removes the prostate gland. This is done by making a surgical incision and removing the prostate gland.
If you are in this group, you will get the TULSA Procedure. The TULSA Procedure is a minimally invasive procedure that uses directional ultrasound to produce very high temperature to ablate (destroy) targeted prostate tissue. The procedure is performed in a MRI suite (the physician can see the prostate at all times throughout the procedure) and uses the TULSA-PRO system to ablate prostate tissue. The procedure combines real-time MRI with robotically-driven directional thermal ultrasound to deliver predictable, physician-prescribed ablation of the prostate. Minimally invasive here means that the procedure is performed through natural openings in your body (the urethra) instead of creating larger openings like in traditional surgery.
Also known as: TULSA-PRO
Safety endpoint - proportion of patients who maintain both urinary continence and erectile potency
Compare preservation of urinary continence and erectile potency, between the 2 arms. Urinary continence is defined as 'pad-free' (0 pads/day) (per EPIC question 5) and erectile potency is defined as erection firmness sufficient for penetration (per IIEF question 2).
Time frame: 12 months post-treatment
Efficacy endpoint - proportion of patients free from treatment failure
Compare the proportion of patients experiencing treatment failure, between the 2 arms. Treatment failure is defined as delivery of any additional intervention for prostate cancer (local or systemic, including adjuvant therapy), or metastatic disease, or prostate cancer-specific death.
Time frame: 36 months post-treatment
Biochemical failure endpoint
Compare the proportion of patients with biochemical failure between the two arms. Biochemical failure is defined as PSA≥ 0.2 ng/mL for the RP arm or PSA nadir plus 2 ng/mL for the TULSA arm (adapted from Phoenix criteria).
Time frame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
Histological failure endpoint
Compare the proportion of patients who have clinically significant disease (defined as ISUP Grade Group 2 or higher) between the two arms.
Time frame: At 12 month post treatment, and also at 24 months post treatment for patients who undergo a repeat TULSA
mpMRI endpoint (for Tulsa arm only)
Characterize the effect of the TULSA Procedure ablation on diagnostic multi-parametric MRI, determined using PI-RADS V2 score, compared to baseline.
Time frame: At 12 month post treatment, and also at 24 months post treatment for patients who undergo a repeat TULSA
Salvage-free survival endpoint
Compare the proportion of patients who are salvage free, between the two arms. Salvage-free survival is defined as freedom from any salvage treatments after the assigned treatment, for both RP arm and TULSA arm. 1 repeat TULSA does not count as Salvage.
Time frame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
Metastases-free survival endpoint
Compare the proportion of patients who are free from metastatic disease between the 2 arms, based on imaging.
Time frame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
Prostate cancer-specific survival endpoint
Compare the proportion of patients who die of prostate cancer between the 2 arms.
Time frame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
Overall survival endpoint
Compare the proportion of patients who die of any cause, between the 2 arms.
Time frame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
Surgical complications endpoint
Compare the frequency and severity of all adverse events between the 2 arms, evaluated by attribution and reported in accordance with Clavien-Dindo classification.
Time frame: At the following study visits post treatment: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5 years
Penile rehabilitation endpoint
Compare the proportion of patients who undergo penile rehabilitation between the 2 arms (penile rehab includes implant insertion, medication/injection, traction or pump device).
Time frame: At the following study visits post treatment: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5 years
Penile length endpoint
Compare the change in penile length from baseline to after treatment, between the 2 arms, as measured by the study doctor.
Time frame: At 1 month and 12 months post-treatment
Blood loss endpoint
Compare the volume of blood lost between the two arms during treatment.
Time frame: During the procedure and immediately after the procedure
Transfusion volume endpoint
Compare the volume of transfused blood between the two arms during treatment.
Time frame: During the procedure and immediately after the procedure
Inpatient hospital stay endpoint
Compare the length of inpatient stay between the two arms.
Time frame: Immediately after the procedure
IIEF-15 Endpoint
Compare International Index of Erectile Function (IIEF-15) scores (for domains of sexual function) between the two arms at follow up, referenced to baseline. Low scores indicate a worse outcome.
Time frame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
IPSS Endpoint
Compare International Prostate Symptom Score (IPSS) scores (for urinary function), between the two arms at follow up, referenced to baseline. Minimum score=0, Maximum score=35. Higher scores indicate a worse outcome.
Time frame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
EPIC Endpoint
Compare (Expanded Prostate Cancer Index Composite) EPIC scores (for domains of urinary, sexual, bowel, and hormonal function), scored from 0 (worst) to 100 (best) between the two arms at follow up, referenced to baseline.
Time frame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
NRS Endpoint
Compare Numerical Rating Scale (NRS) ratings (which measures pain intensity), between the two arms at follow up, referenced to baseline. 0 indicates no pain and 10 indicates worst possible pain.
Time frame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24, and 36 months.
EQ-5D-5L Endpoint
Compare the EQ-5D-5L scores (which measures quality of life), between the two arms at follow up, referenced to baseline. Responses are coded as single-digit numbers expressing the severity level selected in each dimension (Mobility, self-care, usual activities, pain/discomfort and anxiety expression), where level 1 indicates no problem and level 5 indicates extreme problem.
Time frame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24, and 36 months.
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Profound Medical Inc.