Prostate Cancer Clinical Trial
— TACTOfficial title:
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
Verified date | November 2023 |
Source | Profound Medical Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 150 |
Est. completion date | September 30, 2028 |
Est. primary completion date | January 29, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 45 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Male, age 45 to 80 years 2. Biopsy-confirmed adenocarcinoma of the prostate. Biopsy (minimum 10 cores) obtained = 6 weeks and = 6 months before treatment (or at the discretion of PI and approval by the Sponsor). 3. Clinical stage = T2b 4.1 Gleason score = 3 + 4 (Part I only) 4.2 Gleason score 3+4 (Part II only) *now recruiting 5. PSA = 15 ng/ml 6. Eligible for MRI [Form GCP-10131] 7. Eligible for general anesthesia (ASA category = 3) 8. Prostate volume = 90 cc, on Baseline MRI 9. Prostate size = 5.0 cm in sagittal length, and = 6.0 cm in axial diameter, on Baseline MRI 10. Life expectancy = 10 years 11. No calcifications in the planned ultrasound beam path, or at the discretion of the investigator with approval from the Sponsor. Exclusion Criteria: 1. Evidence (including Baseline MRI and bone scan) of extracapsular extension, sphincter involvement, seminal vesicle invasion, lymph node invasion or metastases 2. Suspected tumour on Baseline MRI within 3 mm of the prostatic urethra, or in the prostate apex within 3 mm from the sphincter plane 3. Prior definitive treatment of prostate cancer 4. Prior transurethral resection of the prostate (TURP) 5. Use of 5-alpha reductase inhibitors (5-ARIs) or hormone therapy within 3 months prior to the baseline visit. Baseline PSA must be established after a minimum of 3 months following 5-ARIs discontinuation. Additionally, use of 5-ARIs is not permitted following treatment during the study follow-up period. 6. Prostate calcifications > 1 cm in largest diameter, on Baseline Ultrasound 7. Cysts > 1 cm in largest diameter, on Baseline MRI 8. Bleeding disorder (INR > ULN and PTT > ULN) 9. Abnormal coagulation and current anticoagulant therapy. Patients whose anticoagulation therapy can be temporarily reversed within 7 days prior to treatment are eligible. Platelet inhibitors (ie: ASA) and heparin are not exclusion criteria. 10. Acute unresolved Urinary Tract Infection (UTI) 11. Interest in future fertility 12. History of any other malignancy other than skin cancer, or low grade bladder cancer which has been completely resected, within the previous 2 years. Patients that have had curative treatment of a previous malignancy and no recurrence of that malignancy within the past 2 years will be allowed. 13. Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome 14. Patients with diabetes who have evidence of complications from their diabetes, such as end organ sequelae of diabetes or Hemoglobin A1c > 7%. 15. History of any major rectal or pelvic surgery or radiotherapy 16. History of ulcerative colitis or other chronic inflammatory conditions affecting rectum (includes rectal fistula, anal stenosis) 17. Documented clinical prostatitis requiring therapy within 6 months prior to Treatment 18. History of urethral and bladder outlet disorders, including urethral stricture disease, urethral diverticulae, bladder neck contracture, urethral fistulae, urethral stenting, urethral sling, urethroplasty or chronic indwelling urethral catheter 19. Patients with artificial urinary sphincter or any penile implant 20. Severe neurogenic bladder 21. Untreated bladder stones 22. History of acute urinary retention within the last 12 months 23. Active untreated gross hematuria for any cause 24. Post Void Residual (PVR) bladder volume > 250 mL 25. Obstructing median lobe enlarged out of proportion to the rest of the prostate and protruding significantly into the bladder, sometimes referred to as "ball valve" median lobe, determined on Baseline MRI 26. Any prostate related investigational therapy within 6 months of Visit 1 27. History of Parkinson's disease or multiple sclerosis 28. History of drug abuse 29. Known infectious disease including HIV positivity or AIDS-related illness, HBV and HCV 30. Current unilateral or bilateral hydronephrosis 31. Allergy or contraindications to administration of the GI anti-spasmodic drug: 1. Patients in the USA: Glucagon 2. Patients in Canada and Europe: Buscopan (Hyoscine) 32. Contraindications to administration of gadolinium-based MRI contrast agent (e.g. Magnevist), such as chronic, severe kidney disease, acute kidney injury, history of Sickle Cell Disease, history of anemia, or intolerance/allergy to the contrast agent 33. Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre | London | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Germany | University Hospital of Cologne | Cologne | |
Germany | Universitätsklinikum Heidelberg (University of Heidelberg, Dept of Urology) | Heidelberg | |
Netherlands | Radboud University Medical Center | Nijmegen | |
Spain | ResoFus Alomar (Hospital Universitari De Bellvitge) | Barcelona | |
United States | Johns Hopkins Medicine | Baltimore | Maryland |
United States | University of Chicago | Chicago | Illinois |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Indiana University | Indianapolis | Indiana |
United States | University of California Los Angeles | Los Angeles | California |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Yale Cancer Centre | New Haven | Connecticut |
United States | William Beaumont Hospital | Royal Oak | Michigan |
Lead Sponsor | Collaborator |
---|---|
Profound Medical Inc. |
United States, Canada, Germany, Netherlands, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety Endpoint - Incidence of treatment-emergent adverse events | 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). | 1 year | |
Primary | Efficacy Endpoint - Proportion of patients achieving a PSA nadir = 25% of the pre-treatment baseline value. | Prostate ablation efficacy will be evaluated using the proportion of patients achieving a PSA nadir = 25% of the pre-treatment baseline value. | 1 year | |
Secondary | Erectile Dysfunction Endpoint | Rate of erectile dysfunction, determined by the change from baseline of the proportion of patients with IIEF-5 < 17. | At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years). | |
Secondary | Erection Firmness Endpoint | Rate of erection firmness sufficient for penetration, determined by the change from baseline of the proportion of patients with IIEF item 2 = 2. | At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years). | |
Secondary | Urinary Incontinence Endpoint | 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). | At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years). | |
Secondary | PSA Nadir Endpoint | Proportion of patients achieving PSA nadir = 0.5 ng/ml. | 1 year | |
Secondary | PSA Stability Endpoint | Proportion of patients with PSA = 0.5 ng/ml at the most recent follow-up visit. | At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years). | |
Secondary | Prostate Volume Endpoint | Prostate volume reduction, evaluated on MRI between the treatment day and 12-month follow-up visits. | 1 year | |
Secondary | Prostate Biopsy Endpoint | Proportion of patients with negative prostate biopsy at the 12-month follow-up visit, determined by transrectal ultrasound-guided 10-core biopsy. | 1 year | |
Secondary | IPSS Endpoint | Change in International Prostate Symptom Score (IPSS), between the baseline and most recent follow-up visit. | At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years). | |
Secondary | IIEF Endpoint | 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. | At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years). | |
Secondary | EPIC Endpoint | 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. | At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years). | |
Secondary | Targeting Accuracy Endpoint | 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). | During treatment | |
Secondary | CE-MRI Endpoint | 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. | Immediately after treatment | |
Secondary | mpMRI Endpoint | 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. | 1 year |
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