Prostate CancerCAPTAINNCT05027477
A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer
A study testing Radical Prostatectomy and TULSA Procedure in people with Prostate Cancer and Prostate Adenocarcinoma, run by Profound Medical Inc. at 22 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma
- What is being tested?
- Radical Prostatectomy and TULSA Procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 1 Nov 2021to 31 Aug 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- Age 40 to 80 years, with >10 years life expectancy
- NCCN (favorable and unfavourable) intermediate-risk prostate cancer on biopsy acquired within last 12 months
- Stage ≤cT2c, N0, M0
- ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy or in-bore biopsy
- PSA ≤20ng/mL within last 3 months
- Treatment-naïve
- Planned ablation volume is < 3 cm axial radius from urethra on mpMRI acquired within last 6 months
Who cannot join
- Inability to undergo MRI or general anesthesia
- Suspected tumor is > 30 mm from the prostatic urethra
- Prostate calcifications > 3 mm in maximum extent obstructing ablation of tumor
- Unresolved urinary tract infection or prostatitis
- History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
- Artificial urinary sphincter, penile implant, or intraprostatic implant
Show all 9Show fewer
- Patients who are otherwise not deemed candidates for radical prostatectomy
- Inability or unwillingness to provide informed consent
- History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
United States19 sites
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
Arizona State Urological Institute
Chandler, Arizona, 85224
Cleveland Clinic
Cleveland, Ohio, 44106
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9020
Indiana University
Indianapolis, Indiana, 46202
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Atlantic Urology Medical Group
Long Beach, California, 90806
Urology Group of Southern California
Los Angeles, California, 90017
University of California, Los Angeles
Los Angeles, California, 90024
Comprehensive Urology Medical Group
Los Angeles, California, 90048
East Valley Urological Center
Mesa, Arizona, 85206
Alarcon Urology Center
Montebello, California, 90640
Yale Cancer Center
New Haven, Connecticut, 06511
Pasadena Urological Medical Group
Pasadena, California, 91101
Mayo Clinic
Rochester, Minnesota, 55905
The Urology Place
San Antonio, Texas, 78240
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
Investigate MD
Scottsdale, Arizona, 85255
Stanford Cancer Center
Stanford, California, 94305
Canada2 sites
Lawson Health Research Institute, London Health Sciences Centre
London, Ontario, N6C 2R5
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
About this study
Official title: Customized Ablation of the Prostate With the TULSA Procedure Against Radical Prostatectomy Treatment: a Randomized Controlled Trial for Localized Prostate Cancer (CAPTAIN)
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.
Read the detailed description
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:
- Test whether the TULSA Study Procedure preserves or improves your quality of life (urinary, bowel and sexual functions) at 12 months post-study treatment compared to standard of care (radical prostatectomy).
- Test how many subjects who undergo the TULSA Study Procedure are free from treatment failure by 3 years post-study treatment compared to subjects who undergo the standard of care (radical prostatectomy). Treatment failure is defined as undergoing other additional prostate cancer treatments, spreading of cancer or death caused by cancer.
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.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Being tested
- Radical Prostatectomy, TULSA Procedure
- Keywords
- Prostate ablation, high intensity transurethral ultrasound ablation, MRI-guided, minimally invasive, real-time temperature feedback control, prostate cancer, TULSA, radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical ProstatectomyDevice
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.
TULSA ProcedureDevice
Also called TULSA-PRO
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.
| Study group | Role | What they receive |
|---|---|---|
| Radical Prostatectomy | Active comparator | Patients in this group will undergo Radical prostatectomy. There will be about 67 people in this group. Receives: Device: Radical Prostatectomy |
| TULSA Procedure | Experimental | Patients in this group will undergo TULSA Procedure. There will be about 134 people in this group. Receives: Device: TULSA Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 36 months post-treatment
Secondary outcomes (18)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: At 1 month and 12 months post-treatment
Blood loss endpoint
Compare the volume of blood lost between the two arms during treatment.
Measured: During the procedure and immediately after the procedure
Transfusion volume endpoint
Compare the volume of transfused blood between the two arms during treatment.
Measured: During the procedure and immediately after the procedure
Inpatient hospital stay endpoint
Compare the length of inpatient stay between the two arms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24, and 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Nov 2021
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Profound Medical Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027477
- Sponsor's protocol ID
- GCP-10296
- Acronym
- CAPTAIN
- Status last verified
- Jan 2025
- First submitted
- 18 Aug 2021
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized Ablation of the Prostate With the TULSA Procedure Against Radical Prostatectomy Treatment: a Randomized Controlled Trial for Localized Prostate Cancer (CAPTAIN)
- ClinicalTrials.gov ID
- NCT05027477
- Acronym / sponsor ID
- CAPTAIN / GCP-10296
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Keywords
- Prostate ablation, high intensity transurethral ultrasound ablation, MRI-guided, minimally invasive, real-time temperature feedback control, prostate cancer, TULSA, radical prostatectomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Profound Medical Inc.University, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2036 (estimated)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Test whether the TULSA Study Procedure preserves or improves your quality of life (urinary, bowel and sexual functions) at 12 months post-study treatment compared to standard of care (radical prostatectomy).
- Test how many subjects who undergo the TULSA Study Procedure are free from treatment failure by 3 years post-study treatment compared to subjects who undergo the standard of care (radical prostatectomy). Treatment failure is defined as undergoing other additional prostate cancer treatments, spreading of cancer or death caused by cancer.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radical Prostatectomy | Active comparator | Device: Radical ProstatectomyPatients in this group will undergo Radical prostatectomy. There will be about 67 people in this group. |
| TULSA Procedure | Experimental | Device: TULSA ProcedurePatients in this group will undergo TULSA Procedure. There will be about 134 people in this group. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male
- Age 40 to 80 years, with >10 years life expectancy
- NCCN (favorable and unfavourable) intermediate-risk prostate cancer on biopsy acquired within last 12 months
- Stage ≤cT2c, N0, M0
- ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy or in-bore biopsy
Key exclusion criteria (9 listed)
- Inability to undergo MRI or general anesthesia
- Suspected tumor is > 30 mm from the prostatic urethra
- Prostate calcifications > 3 mm in maximum extent obstructing ablation of tumor
- Unresolved urinary tract infection or prostatitis
- History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical ProstatectomyIf 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. | Device | Radical Prostatectomy |
| TULSA ProcedureAlso: TULSA-PROIf 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. | Device | TULSA Procedure |
Primary outcome
Safety endpoint - proportion of patients who maintain both urinary continence and erectile potency
Time frame: 12 months post-treatment
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).
Efficacy endpoint - proportion of patients free from treatment failure
Time frame: 36 months post-treatment
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.
18 secondary outcomes
Biochemical failure endpoint
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
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)
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
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
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
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
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
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
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
Time frame: At 1 month and 12 months post-treatment
Blood loss endpoint
Time frame: During the procedure and immediately after the procedure
Transfusion volume endpoint
Time frame: During the procedure and immediately after the procedure
Inpatient hospital stay endpoint
Time frame: Immediately after the procedure
IIEF-15 Endpoint
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
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
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
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
Time frame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24, and 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical Prostatectomy and TULSA Procedure in people with Prostate Cancer and Prostate Adenocarcinoma, run by Profound Medical Inc. at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety endpoint - proportion of patients who maintain both urinary continence and erectile potency (time frame: 12 months post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.