Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients in this group will undergo Radical prostatectomy. There will be about 67 people in this group.

Patients in this group will undergo TULSA Procedure. There will be about 134 people in this group.

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.

Radical Prostatectomy

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.

TULSA Procedure

Gina Clarke

Arthi Rajamohan

Marchelle Mehan

Rahul Mehan, MD

Joseph Greco

Pooya Banapour, MD

Francisco Capilla

Bart Wachs, MD

Carlos Lopez

John Kowalczyk, DO

Shahzada Khurram

Kiarash Michel, MD

Yvette Zuniga

Juan Antonio Alarcon, MD

Shahin Chandrasoma, MD

Julia Gallagher-Teske

Kristine Talavera

Geoffrey Sonn, MD

Ali-Reza Sharif-Afshar

Ali-Reza Sharif-Afshar, MD

Kristin DeFrancesco

Sandeep Arora, MD

Preston Sprenkle, MD

John Applegate

Michael Koch, MD

Carolyn Chapman

Sandy Moore-Cooper

Christian Pavlovich, MD

Phillip McDuffie

Xiaosong Meng, MD

Victoria Sarwan

Naveen Kella, MD

Wendy Shoff

Brant Inman, MD

Marlene Kebabdjian

Laurence Klotz, MD

Kaisa Reunanen

Mikael Anttinen, MD PhD

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:

* 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.

A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer

Customized Ablation of the Prostate With the TULSA Procedure Against Radical Prostatectomy Treatment: a Randomized Controlled Trial for Localized Prostate Cancer (CAPTAIN)

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).

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.

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).

Compare the proportion of patients who have clinically significant disease (defined as ISUP Grade Group 2 or higher) between the two arms.

Characterize the effect of the TULSA Procedure ablation on diagnostic multi-parametric MRI, determined using PI-RADS V2 score, compared to baseline.

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.

Compare the proportion of patients who are free from metastatic disease between the 2 arms, based on imaging.

Compare the proportion of patients who die of prostate cancer between the 2 arms.

Compare the proportion of patients who die of any cause, between the 2 arms.

Compare the frequency and severity of all adverse events between the 2 arms, evaluated by attribution and reported in accordance with Clavien-Dindo classification.

Compare the proportion of patients who undergo penile rehabilitation between the 2 arms (penile rehab includes implant insertion, medication/injection, traction or pump device).

Compare the change in penile length from baseline to after treatment, between the 2 arms, as measured by the study doctor.

Compare the volume of blood lost between the two arms during treatment.

Compare the volume of transfused blood between the two arms during treatment.

Compare the length of inpatient stay between the two arms.

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.

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.

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.

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.

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.

Profound Medical Inc.

Symptoms and General Pathology

Prostatic Hyperplasia

Hyperplasia

Transurethral ultrasound ablation procedure

Kristi Maya

Jennifer O' Brien

Robert Princenthal, MD

Martin Cohen, MD

Ann Dunshee

Chandler Dora, MD

Erica Zahos

Sherrie Keller

Edward Steiner, MD

Anna Manning-Mortimer

Daniel Costa, MD

This patient registry will capture data from patients who have been or who are undergoing the transurethral ultrasound ablation (TULSA) procedure as part of their routine clinical care. The registry will shed light on real-world outcomes of safety and efficacy of the procedure and understand how a patient's quality of life is affected throughout their follow-up and lifetime.

This registry will capture data on patients undergoing customized transurethral ultrasound ablation (TULSA) as part of their routine clinical care. The aim of collecting such data is to further evaluate real-world outcomes of safety and efficacy of this treatment. The collection of this data is intended to form an evidence-base from which conclusions can be drawn on how to optimize outcomes to improve patient care and QOL, and further expand on knowledge of practice trends and treatment costs.

The primary safety objective is to estimate the rate of complications attributable to the TULSA Procedure. The primary efficacy objective is estimating the proportion of patients who are free from primary treatment failure after the TULSA Procedure.

Patients being offered TULSA Procedure will be invited to participate in the registry. Patients who have already undergone TULSA will also be allowed to join the registry. Hundreds to thousands of patients across sites in US, Canada and Europe will be followed as per routine clinical care at 3 months, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years and annually lifelong thereafter. Patients will remain active in the registry until they voluntarily withdraw or die. At each visit, patients will complete a set of questionnaires that is sent to them by email.

* Informed consent will be collected prior to enrolling the patient into the Registry.
* Initial baseline information will be collected (eg. demographics, medical history, concomitant medication, prostate MRI, prostate biopsy, PSA, and QOL Questionnaires)
* TULSA Procedure treatment assessment and complications will be collected from clinic records from treatment day. Optional financial tracking information may also be collected if patient consents to this portion of the registry.
* At follow-up visits, a set of data points will be collected (eg. PSA, complications, QoL Questionnaires, survival assessments, and optional financial tracking information)

All Registry data will be collected and stored in an electronic database capture system called Castor. Castor is validated and compliant with all applicable laws and regulations, including ICH E6 GCP, 21 CFR Part 11, EU annex II, General Data Protection Regulation (GDPR), HIPAA (US), ISO 9001 and ISO 27001. Only sites and sponsor personnel will have access to the database. On site and/or remote study monitoring will be undertaken to check source documents and accuracy of data entry. All reasonable methods will be used to try to minimize missing data, however, some missing data is expected to occur. No interpolation of missing data will occur. Standard descriptive statistics, including the mean, standard deviation, median, range, proportion and frequency, will be used throughout to summarize results. Measures will be presented, and 95% confidence intervals will be constructed for selected measures, such as efficacy and safety. As a primarily descriptive study, analyses will be performed at the p=0.05 level of significance and exact analyses will be used wherever possible.

Customized TULSA-PRO Ablation Registry

estimating the rate of complications (Clavien-Dindo grades III - IV) attributable to the TULSA Procedure

Estimating the proportion of patients who are free from primary treatment failure after the TULSA Procedure.

complications arising from TULSA-PRO treatment, categorized based on the type of corrective therapy needed using the Clavien-Dindo classification system

in men with prostate cancer, biopsy data to assess if there are changes to either cancer or clinically significant cancer in the treatment region.

Multi-parametric prostate MRI data to measure prostate volume reduction

Identify presence of any suspicious (i.e. suspected for cancer) lesions.

PSA data to identify changes in PSA from baseline.

Patient-reported qualify of life (QoL) questionnaire answers to assess changes in erectile dysfunction, ejaculatory function and erection firmness:

IIEF-5 (International Index of Erectile Function) Minimum score=5, Maximum score=25. Lower scores indicate a worse outcome.

Patient-reported qualify of life (QoL) questionnaire answers to assess changes in erectile dysfunction, ejaculatory function and erection firmness.

2 questions from IIEF-15 (International Index of Erectile Function) Low scores indicate a worse outcome.

Patient-reported qualify of life (QoL) questionnaire answers to assess changes in urinary symptoms and urinary incontinence:

IPSS (International Prostate Symptom Score) Minimum score=0, Maximum score=35. Higher scores indicate a worse outcome.

Patient-reported qualify of life (QoL) questionnaire answers to assess changes in urinary symptoms and urinary incontinence:

2 questions from EPIC-26 (Expanded Prostate Cancer Index Composite)

in men with prostate cancer, survival data will be captured to identify percentage of participants who are free from biochemical recurrence.

in men with prostate cancer, survival data will be captured to identify percentage of participants who are free from undergoing any additional salvage treatment.

in men with prostate cancer, survival data will be captured to identify percentage of participants who are free from undergoing any additional systemic therapy.

in men with prostate cancer, survival data will be captured to identify percentage of participants who are free from distant metastases.

in men with prostate cancer, survival data will be captured to identify freedom from disease-specific mortality.

in men with prostate cancer, survival data will be captured to identify freedom from overall mortality.

Financial tracking information such total cost to patient, private insurance, public insurance) associated with treatment and visit will be collected.

Additional treatments related to urinary symptoms attributed to BPH will be collected, including types of treatments.

Additional treatments related to urinary symptoms attributed to BPH will be collected, including dates of these treatments.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer	NCT05027477	Prostate Cancer Prostate Adenoc...	Radical Prostat... TULSA Procedure	40 Years - 80 Years	Profound Medical Inc.
Customized TULSA-PRO Ablation Registry	NCT05001477	Prostate Cancer Prostate Adenoc... Benign Prostati...	TULSA Procedure	18 Years -	Profound Medical Inc.

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