Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgens

After three months of neoadjuvant ADT with Degarelix, the subject will undergo whole-prostate gland MRI-guided transurethral ultrasound ablation (TULSA) (TULSA-PRO, Profound Medical Inc., Toronto, Canada) treatment.

Degarelix is injected subcutaneously into the fatty tissue of the abdomen. A typical protocol consists of a starting dose of 240 mg with a maintenance dose of 80 mg administered every 28 days. In this study, one starting dose and two maintenance doses of Degarelix will be administered between baseline and TULSA treatment in accordance with the terms of Degarelix marketing authorizations.

Degarelix

MRI-guided transurethral ultrasound ablation (TULSA) (TULSA-PRO, Profound Medical Inc., Toronto, Canada) will be used to deliver whole-prostate gland treatment in accordance with the terms of TULSA marketing authorizations. The treating physicians will contour the entire prostate gland for a whole gland ablation.

MRI-guided transurethral ultrasound ablation (TULSA)

Mikael HJ Anttinen, MD, PhD

Kaisa Reunanen

Clinical studies have shown that magnetic resonance imaging-guided transurethral ultrasound ablation (TULSA) of the prostate is safe and effective. In the TULSA procedure, prostate tissue is killed by heating with ultrasound. This clinical trial explores if adding drug therapy with Degarelix before TULSA has the potential to improve further the effectiveness of TULSA in the treatment of localized prostate cancer, especially for patients with more aggressive diseases.

Androgen deprivation therapy (ADT) has been shown to reduce prostate and tumor size. In this study, magnetic resonance imaging (MRI) is used to investigate the effect of Degarelix ADT on the properties of prostate tissue that can affect the heating of the tissues in the TULSA procedure. The main goal is to find out if ADT can change the tissue structure in a way that improves the ability of the TULSA procedure to heat tissues and better kill the diseased tissue, reducing the chance of the disease reoccurring. ADT and the TULSA procedure can help patients with more aggressive diseases avoid the adverse effects associated with surgery or radiation therapy. Specific objectives are:

1. To measure the change in prostate and tumor size, tissue structural changes, and the blood flow within the prostate after ADT.
2. To measure the distribution of heating over the prostate after TULSA treatment.
3. To evaluate complications and genitourinary function and quality of life with patient-reported outcome measures.
4. To evaluate local cancer control and longer-term oncological outcomes after combination therapy of neoadjuvant ADT and TULSA treatment.

About 15 subjects will participate. Each will receive Degarelix for three months, followed by whole-prostate gland TULSA treatment, and be followed for five years. Throughout the study, subjects will receive MRI scans and complete questionnaires regarding functional status and quality of life to understand the side effects.

Procedure: Magnetic resonance imaging-guided transurethral ultrasound ablation of the prostate (TULSA)

Drug: Degarelix

Neoadjuvant ADT With TULSA in the Treatment of Intermediate Risk Prostate Cancer

Effect of Neoadjuvant Degarelix on MRI-guided Transurethral Ultrasound Ablation (TULSA) in Patients With Intermediate-risk Prostate Cancer: A Pilot Study

The prostate volume change will be determined by comparing the prostate volume measured on T2-weighted MRI at three, and 12 months after TULSA to that at TULSA procedure.

The change in maximum urinary flow rate (Qmax) (ml/s) will be determined by comparing Qmax values at 12 weeks of ADT and three, 12, 36, and 60 months post-TULSA to that at baseline and TULSA procedure.

The change in average urinary flow rate (ml/s) will be determined by comparing average flow rate values at 12 weeks of ADT and three, 12, 36, and 60 months post-TULSA to that at baseline and TULSA procedure.

The change in post-void residual volume (PVR) (ml) will be determined by comparing PVR values at 12 weeks of ADT and three, 12, 36, and 60 months post-TULSA to that at baseline and TULSA procedure.

The change in voided volume (ml) will be determined by comparing voided volume values at 12 weeks of ADT and three, 12, 36, and 60 months post-TULSA to that at baseline and TULSA procedure.

3T prostate multiparametric MRI three and twelve months after TULSA treatment will be assessed for residual or recurrent disease according to the Prostate Imaging for Recurrence Reporting (PI-RR) system guidelines. The proportion of subjects with a suspicious lesion on MRI, defined as lesion ≥ PI-RR 3, will be reported.

The prostate volume change will be determined by comparing the prostate volume measured on T2-weighted MRI at four, eight, and 12 weeks of ADT to that at baseline.

The prostate tumor volume change will be determined by comparing the prostate tumor volume measured on T2-weighted MRI at four, eight, and 12 weeks of ADT to that at baseline.

The frequency and severity of adverse events after neoadjuvant Degarelix and TULSA treatment will be determined by using the CTCAE v6.0 classification. Adverse events attributed to TULSA will also be graded using the Clavien Dindo classification for surgical complications.

The prostate tumor-capsule contact length change will be determined by comparing the prostate tumor-capsule contact length measured on T2-weighted MRI at four, eight, and 12 weeks of ADT to that at baseline.

The change in prostate vascular perfusion will be determined by comparing average blood flow values in the prostate measured on dynamic contrast-enhanced T1-weighted MRI at four, eight, and 12 weeks of ADT to that at baseline.

The change in prostate tumor vascular perfusion will be determined by comparing average blood flow values in the prostate tumor measured on dynamic contrast-enhanced T1-weighted MRI at four, eight, and 12 weeks of ADT to that at baseline.

The change in periprostatic, prostate and tumor tissue structures will be determined by comparing the radiomics features extracted from T2-weighted, T2 relaxation time mapping, and diffusion-weighted images at four, eight, and 12 weeks of ADT to that at baseline.

Thermal coverage of the target volume achieved by whole-prostate gland TULSA will be determined by comparing physician-defined target boundaries to MRI measurements of temperature distributions, thermal dose distributions, and acute treatment-induced perfusion defect immediately post-treatment.

The change in QoL and functional status outcomes will be determined by comparing the summary scores of urinary incontinence, urinary irritative/obstructive, bowel, sexual and hormonal domains of the Expanded Prostate Index Composite-26 (EPIC-26) questionnaire at 12 weeks of ADT to that at baseline. EPIC-26 contains 26 items with response options for each EPIC item forming a Likert Scale, and multi-item scale scores transformed linearly to a 0-100 scale, with higher scores representing better functional status/QoL.

The change in lower urinary tract symptoms will be determined by comparing the International Prostate Symptom Score (IPSS) at 12 weeks of ADT to that at baseline. The possible scores for the IPSS questionnaire range from 0 to 35, with higher scores representing worse symptoms.

The change in erectile function will be determined by comparing the International Index of Erectile Function (IIEF-5) score at 12 weeks of ADT to that at baseline. The possible scores for the IIEF-5 range from 5 to 25, with higher scores representing a better erectile function.

The change in QoL and functional status outcomes will be determined by comparing the summary scores of urinary incontinence, urinary irritative/obstructive, bowel, sexual and hormonal domains of the Expanded Prostate Index Composite (EPIC-26) questionnaire at three, six, 12, 36 and 60 months post-TULSA to that at baseline and TULSA procedure. EPIC-26 contains 26 items with response options for each EPIC item forming a Likert Scale, and multi-item scale scores transformed linearly to a 0-100 scale, with higher scores representing better functional status/QoL.

The change in lower urinary tract symptoms will be determined by comparing the International Prostate Symptom Score (IPSS) at three, six, 12, 36 and 60 months post-TULSA to that at baseline and TULSA procedure. The possible scores for the IPSS questionnaire range from 0 to 35, with higher scores representing worse symptoms.

The change in erectile function will be determined by comparing the International Index of Erectile Function (IIEF-5) score at three, six, 12, 36 and 60 months post-TULSA to that at baseline and TULSA procedure. The possible scores for the IIEF-5 range from 5 to 25, with higher scores representing a better erectile function.

The frequency and severity of adverse events after neoadjuvant Degarelix and TULSA treatment will be determined using the CTCAE v6.0 classification. Adverse events attributed to TULSA will also be graded using the Clavien Dindo classification for surgical complications.

Salvage therapy-free survival will be defined as freedom from radical salvage treatments for prostate cancer including radical prostatectomy, radiotherapy, or ablation, and reported as the proportion of subjects who have not reached those events.

Systemic therapy-free survival will be defined as freedom from additional systemic therapy including but not limited to additional ADT or chemotherapy for the treatment of prostate cancer, and reported as the proportion of subjects who have not reached those events.

Failure-free survival will be defined as freedom from salvage treatment, systemic treatment, metastases, or death from prostate cancer, and reported as the proportion of subjects who have not reached those events.

Metastasis-free, prostate cancer-specific and overall survivals will be assessed one, three, and five years after TULSA and reported as the proportion of subjects who have not reached those endpoints.

PSA at each timepoint, as well as PSA nadir, will be reported. The proportion of subjects with biochemical failure, defined as a PSA value more than 2.0 ng/ml above nadir, will be reported.

Histopathologic verification of treatment response to TULSA treatment will be confirmed at 12 months post-TULSA with targeted plus 10-12-core systematic biopsy. The proportion of subjects with a clinically-significant disease, defined as Gleason grade ≥ 3 + 4 and ISUP (International Society of Urological Pathology) grade group ≥ 2 prostate cancer, on biopsy, will be reported.

Histopathologic verification of treatment response to TULSA treatment will be confirmed at 12 months post-TULSA with targeted plus 10-12-core systematic biopsy. The number, location, grade, and percent of cancer involvement within each core will be collected. The proportion of subjects with any prostate cancer on biopsy, will be reported.

Turku University Hospital

Adenocarcinoma

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

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.

Magnetic resonance imaging-guided transurethral ultrasound ablation of whole-gland prostate tissue.

Magnetic resonance imaging-guided transurethral ultrasound ablation is a novel minimally-invasive procedure where the therapeutic endpoint is prostate ablation through thermal coagulation.

MRI-guided Transurethral Ultrasound Ablation

Scott Eggener, MD

A prospective, multi-center, single-arm study, planned in 150 patients. The primary objective of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer.

Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral ultrasound therapy system (TULSA-PRO). The technology is developed for patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue.

The treatment is conducted within a MRI suite, which enables real-time temperature images of the heated region to be acquired as the ultrasonic treatment is delivered. Using MRI thermometry during treatment, dynamic temperature feedback control over the intensity of the ultrasound beams and rotation of the Ultrasound Applicator can shape the pattern of thermal coagulation accurately and precisely in the prostate gland.

It provides advantages of a non-invasive procedure with short treatment times.

Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer

Evaluation of the TULSA-PRO MRI-Guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer: a Prospective, Single-Arm, Pivotal Clinical Study

Frequency and severity of all adverse events will be evaluated by attribution and reported in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).

Prostate ablation efficacy will be evaluated using the proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.

Rate of erectile dysfunction, determined by the change from baseline of the proportion of patients with IIEF-5 \< 17.

Rate of erection firmness sufficient for penetration, determined by the change from baseline of the proportion of patients with IIEF item 2 ≥ 2.

Rate of urinary incontinence, determined by the change from baseline of the proportion of patients with EPIC item 5 ≥ 1 (one or more pads per day).

Proportion of patients achieving PSA nadir ≤ 0.5 ng/ml.

Proportion of patients with PSA ≤ 0.5 ng/ml at the most recent follow-up visit.

Prostate volume reduction, evaluated on MRI between the treatment day and 12-month follow-up visits.

Proportion of patients with negative prostate biopsy at the 12-month follow-up visit, determined by transrectal ultrasound-guided 10-core biopsy.

Change in International Prostate Symptom Score (IPSS), between the baseline and most recent follow-up visit.

Change in the Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Satisfaction domains of the International Index of Erectile Function (IIEF-15), between the baseline and most recent follow-up visit.

Change in Urinary, Bowel, Sexual and Hormonal domains of the Expanded Prostate Cancer Index Composite (EPIC), between the baseline and most recent follow-up visit.

Conformal prostate ablation, measured quantitatively between the target prostate volume and the target temperature isotherm on MRI thermometry acquired during the TULSA-PRO procedure, and described using three measures of targeting accuracy (Dice Similarity Coefficient; Over- and under-targeted volumes; Linear targeting in mm).

Conformal prostate ablation, assessed qualitatively by visualizing the peripheral region of enhancement surrounding the non-perfused volume (NPV) on contrast-enhanced (CE)-MRI acquired immediately after treatment.

Characterize the effect of the TULSA-PRO ablation on diagnostic multi-parametric prostate MRI (mpMRI), determined using PI-RADS v2 performed at the Baseline and 12-month follow-up visits.

Ultrasound ablation of focal prostate cancer

Transurethral MR-Thermometry Guided Ultrasound Ablation of the Prostate

TULSA-PRO

Jill M Harper, Ph.D.

Peter A Pinto, M.D.

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Background:

The ability to treat early prostate cancer is still limited. Thermal ablation methods are being tested for focal prostate cancer therapy. Researchers want to improve on these methods.

Objective:

To understand if Transurethral UltraSound Ablation (TULSA) in combination with MRI guidance is useful to treat localized prostate cancer.

Eligibility:

English-speaking adults ages 18 and older with localized prostate cancer that can be seen on MRI and can be treated by thermal ablation.

Design:

Participants will be screened with the following:

* Medical history
* Physical exam
* Digital rectal exam
* Blood and urine tests
* Electrocardiogram
* Tumor biopsy
* Questionnaire to assess urinary tract symptoms
* MRI of the pelvis. The MRI scanner is a long, narrow tube. Participants will lie on a bed that moves in and out of the scanner.

Participants may also be screened with the following:

* Echocardiogram
* Chest x-ray
* Bone scan
* Urodynamic studies to see how well the bladder, sphincters, and urethra hold and release urine
* MRI of the brain
* Transrectal ultrasound
* Computer tomography (CT) scan of the chest, abdomen, and pelvis. A CT scan is a series of x-ray images taken of parts of the body.

Some screening tests will be repeated during the study.

Participants will have the TULSA procedure. They will have an MRI for guidance. A small ultrasound applicator will be placed into their urethra. It uses heat to destroy the cancer areas in the prostate. It is controlled by a robotic arm. A cooling catheter will be placed into their rectum.

Participants will use a urethral catheter for 1-7 days.

Participants will have follow-up visits at 3, 6, 12, 18, 24, and 36 months.

Background:

Prostate cancer is relatively slow growing, with doubling times for local tumors estimated at 2 to 4 years.

Some prostate cancers prove to be small, low grade, and noninvasive and they appear to pose little risk to the life or health of the host. Recent patient series suggest that 20% to 30% of men undergoing radical prostatectomy have pathologic features in the radical prostatectomy specimen consistent with an insignificant or "indolent" cancer which poses little threat to life or health.

We propose that participants with low volume and low grade disease can be best served with focal ablation of the visible prostate cancer without the side effects of urinary incontinence and erectile dysfunction associated with radiation therapy or radical surgery.

Focal Therapy for prostate cancer has gained popularity however prior studies demonstrate a failure rate as high as 50% with a laser.

Objective:

To determine the feasibility of magnetic resonance image (MRI)-guided ultrasound-induced thermal therapy of biopsy-confirmed and MRI visible, prostate tumor(s) using the TULSA Thermal Therapy System (Profound Medical)

Eligibility:

Subjects with prostate cancer, amenable for ultrasound ablation

Organ confined clinical T1c or clinical T2a prostate cancer, visible on MRI, and confirmed by prostate biopsy

Adequate organ and marrow function

Prostate-specific antigen (PSA) \< 20 ng/ml

Age \>=18 years

Design:

Study testing feasibility and tolerability of ultrasound ablation of focal prostate cancer.

It is anticipated that 15 participants will be accrued for this study.

Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer

Magnetic Resonance Image (MRI) Guided High Energy Ultrasound for Focal Prostate Cancer Ablation

.All IPD recorded in the medical record will be shared with intramural investigators upon request

To determine the feasibility of magnetic resonance image (MRI)-guided ultrasound-induced thermal therapy of biopsy-confirmed and MRI visible, prostate tumor(s) using the TULSA Thermal Therapy System (Profound Medical)

Address short- and long-term complication rates of study treatment by tabulating adverse events by grade according to CTCAE, and analyzing and reporting descriptively

Determine if focal ablation of MRI visible, biopsy-confirmed prostate cancer using the TULSA Thermal Therapy System (Profound Medical) platform can successfully ablate targeted prostate cancer lesions in \>50% of participants

Observe thermal damage on post-contrast MRI which extends into areas of the Rectum or Urethra; assess frequency of not completing the procedure

Use descriptive statistical analysis to examine serial PSA, PSA density, changes in imaging and biopsy, International Prostate Symptom Score (IPSS), and Sexual Health Inventory for Men (SHIM)

National Cancer Institute (NCI)

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant ADT With TULSA in the Treatment of Intermediate Risk Prostate Cancer	NCT05917860	Localized Prost... Castration-Naiv... Intermediate Ri... Prostate Cancer	Degarelix MRI-guided tran...	40 Years - 80 Years	Turku University Hospital
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.
Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer	NCT02766543	Prostate Cancer	MRI-guided Tran...	45 Years - 80 Years	Profound Medical Inc.
Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer	NCT04808427	Prostate Cancer	TULSA-PRO	18 Years -	National Institutes of Health Clinical Center (CC)
Customized TULSA-PRO Ablation Registry	NCT05001477	Prostate Cancer Prostate Adenoc... Benign Prostati...	TULSA Procedure	18 Years -	Profound Medical Inc.

Spots Global Cancer Trial Database for tulsa

Every month we try and update this database with for tulsa cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tulsa

Every month we try and update this database with for tulsa cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tulsa cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.