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 (Protocol number: GCP-10100)
Johns Hopkins Kimmel Cancer Center in Baltimore
This is a prospective, multi-center, single-arm study, planned in 110 patients. The primary objective of the study is to further evaluate the safety and effectiveness of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO). The system is designed to destroy prostate tissue under Magnetic Resonance Imaging (MRI) guidance using ultrasound energy.The use of TULSA-PRO system in this research study is investigational. The word “investigational” means that TULSA-PRO system is not approved for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of TULSA-PRO system in this study. People diagnosed with prostate cancer that is low- to intermediate- risk and confined to the prostate gland may join.
To be eligible for this study, patients must be 45 years to 80 years old, must have biopsy-confirmed adenocarcinoma of the prostate. Biopsy (minimum 10 cores) obtained greater than or equal to 6 weeks and less than or equal to 6 months before treatment, or at the discretion of PI; clinical stage less than or equal to T2b; Gleason score less than or equal to 3 + 4; PSA less than or equal to 15 ng/ml; are eligible for MRI [Form GCP-10131]; are eligible for general anesthesia (ASA category equal to 3); have prostate volume less than or equal to 90 cc, on Baseline MRI; have prostate size less than or equal to 5.0 cm in sagittal length, and less than or equal to 6.0 cm in axial diameter, on Baseline MRI; have Life expectancy greater than or equal to 10 years. Patients must not have Evidence (including Baseline MRI and bone scan) of extracapsular extension, sphincter involvement, seminal vesicle invasion, lymph node invasion or metastases; must not have Suspected tumour on Baseline MRI within 3 mm of the prostatic urethra, or in the prostate apex within 3 mm from the sphincter plane; must not have prior definitive treatment of prostate cancer; must not have prior transurethral resection of the prostate (TURP); must not have prior 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; must not have Prostate calcifications greater than 1 cm in largest diameter, on Baseline Ultrasound; must not have Cysts greater than 1 cm in largest diameter, on Baseline MRI; must not have Bleeding disorder (INR greater than ULN and PTT greater than ULN); must not have 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; must not have acute unresolved Urinary Tract Infection (UTI); must not have interest in future fertility; must not have 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; must not have peripheral arterial disease with intermittent claudication or Leriches Syndrome; must not have diabetes who have evidence of complications from their diabetes, such as end organ sequelae of diabetes or Hemoglobin A1c greater than 7%; must not have history of any major rectal or pelvic surgery or radiotherapy; must not have history of ulcerative colitis or other chronic inflammatory conditions affecting rectum (includes rectal fistula, anal stenosis); must not have documented clinical prostatitis requiring therapy within 6 months prior to Treatment; must not have 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; must not have artificial urinary sphincter or any penile implant; must not have severe neurogenic bladder; must not have untreated bladder stones; must not have history of acute urinary retention within the last 12 months; must not have Active untreated gross hematuria for any cause; must not have Post Void Residual (PVR) bladder volume greater than 250 mL; must not have 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; must not have any prostate related investigational therapy within 6 months of Visit 1; must not have history Parkinson's disease or multiple sclerosis; must not have history of drug abuse; must not have known infectious disease including HIV positivity or AIDS-related illness, HBV and HCV; must not have current unilateral or bilateral hydronephrosis; must not have Allergy or contraindications to administration of the GI anti-spasmodic drug (Glucagon0 ; must not have 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; must not have 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.
Eligible patients will be have the TULSA Procedure at a 3T MRI location in the hospital. Following the procedure patients will have One-Month follow-up visit, Three-Month follow-up visit, Six-Month follow-up visit and Twelve-Month follow-up visit then yearly Follow-up Visits (2, 3, 4, 5 years). Additional follow-up visits may be required based on the discretion of the study doctor.
08/11/2020 05:02 AM