Prostate Carcinoma Clinical Trial
Official title:
Focal Prostate Ablation for Intermediate Grade Cancer Utilizing TULSA Profound System
This clinical trial tests whether the magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) procedure is safe and effective in treating patients with intermediate grade prostate cancer. MRI-guided TULSA ablation is a minimally invasive procedure that uses an ultrasound device guided by MRI imaging to deliver high-energy sound waves, producing very high temperature to ablate (destroy) tumor cells in a targeted manner. The MRI-guided TULSA procedure may help patients avoid surgery and help improve prostate cancer patients' quality of life.
PRIMARY OBJECTIVE: I. To perform the TULSA procedure for safety and efficacy outcomes in men aged 45 to 80 years with biopsy-confirmed, National Comprehensive Cancer Network (NCCN) intermediate-risk prostate cancer. SECONDARY OBJECTIVE: I. To assess patient-reported metrics for quality of life (QOL). II. To assess return to normal activity. III. Compare economic benefit as noted from Expanded Prostate Cancer Index Composite (EPIC) questionnaire. OUTLINE: Patients undergo MRI-guided TULSA. Patients may also undergo digital rectal exam (DRE), cystoscopy, biopsy, bone scan, prostate specific membrane antigen (PSMA) positron emission tomography (PET), and/or multiparametric MRI (mpMRI) at screening. After completion of study treatment, patients are followed at 3, 6, 9, 12, 15, 18, 21 and 24 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04457232 -
Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation
|
Phase 1 | |
| Active, not recruiting |
NCT03661437 -
Systemic Light Exposure in Preventing Frailty in Older Patients With Prostate Cancer on Hormonal Therapy
|
Early Phase 1 | |
| Completed |
NCT02337465 -
KV-CBCT and Ultrasound Imaging in Guiding Radiation Therapy in Patients With Prostate, Liver, or Pancreatic Cancer
|
N/A | |
| Completed |
NCT03013413 -
Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy
|
N/A | |
| Recruiting |
NCT06037863 -
Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial
|
N/A | |
| Active, not recruiting |
NCT03580499 -
Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy
|
N/A | |
| Completed |
NCT03326440 -
Virtual Environment Radiotherapy to Improve Patients' Compliance to Radiotherapy (RT) in Prostate Cancer
|
N/A | |
| Recruiting |
NCT04597359 -
To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring
|
Phase 2 | |
| Active, not recruiting |
NCT03263650 -
Study of Olaparib Maintenance Following Cabazitaxel-Carbo in Men With AVPC
|
Phase 2 | |
| Active, not recruiting |
NCT04600336 -
Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT05895279 -
Assessment of Research Digest Impact for Minority With Prostate Cancer, MiCAP Phase III Study
|
N/A | |
| Active, not recruiting |
NCT04299620 -
Micro-Ultrasound for the Detection and Localization of Prostate Cancer Tumors in Patients Undergoing Radical Prostatectomy
|
N/A | |
| Completed |
NCT04976257 -
Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion
|
Early Phase 1 | |
| Completed |
NCT02957981 -
The Genetic Education for Men Trial: Web-Based Education vs. Standard Care
|
N/A | |
| Withdrawn |
NCT03408561 -
Social Media Listening in Improving Clinical Trial Recruitment in Patients With Cancer
|
N/A | |
| Enrolling by invitation |
NCT06347809 -
DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine
|
||
| Enrolling by invitation |
NCT04254133 -
Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study
|
||
| Recruiting |
NCT05519878 -
Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers
|
N/A | |
| Recruiting |
NCT02994758 -
Development of Diagnostics and Treatment of Urological Cancers
|
N/A | |
| Completed |
NCT01497431 -
Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants
|
Phase 1 |