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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-03567 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This clinical trial tests whether the magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) procedure is safe and effective in treating patients with low to 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) low to 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (MRI-guided TULSA) | Experimental | Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI-Guided Transurethral Ultrasound Ablation | Procedure | Undergo MRI-Guided TULSA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients free from treatment failure | 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. | At 24 months post-treatment |
| Proportion of patients who maintain both urinary continence and erectile potency | Continence is defined as 'pad-free' (0 pads/day), and potency is defined as erection firmness sufficient for penetration (Expanded Prostate Cancer Index Composite [EPIC]). Two-sided, 95% Pearson-Clopper confidence interval (CI) will be calculated for each intervention arm separately, and the difference in safety outcomes, along with exact 95% two-sided CI will be calculated. | At 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical failure | In the absence of a validated threshold for biochemical failure in the setting of ablative therapies, the Phoenix criteria will be adopted for the transurethral ultrasound ablation (TULSA) procedure (nadir + 2 ng/mL). Prostate-specific antigen (PSA) is measured at baseline/procedure, 3, 6, 9, 12, 15, 18, 21, and 24 months. It's measured using Scale Grade Group 1, 2, 3, and 4. |
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Inclusion Criteria:
Exclusion Criteria:
Inability to undergo MRI or general anaesthesia
Suspected tumour > 30 mm from the prostatic urethra or < 14 mm from the prostatic urethra
Prostate calcifications > 3 mm in maximum extent obstructing ablation of tumor on low-dose pelvic computed tomography (CT)
Unresolved urinary tract infection or prostatitis
History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
Artificial urinary sphincter, penile implant or intraprostatic implant
Less than 10 years life expectancy
Patients who are otherwise not deemed candidates for radical prostatectomy (RP)
Inability or unwillingness to provide informed consent
History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| David A Woodrum, MD, PhD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Questionnaire Administration | Other | Ancillary studies |
|
| Digital Rectal Examination | Procedure | Undergo DRE |
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| Cystoscopy | Procedure | Undergo cystoscopy |
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| Biopsy | Procedure | Undergo biopsy |
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| Bone Scan | Procedure | Undergo bone scan |
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| PSMA PET Scan | Procedure | Undergo PSMA PET |
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| Multiparametric Magnetic Resonance Imaging | Procedure | Undergo mpMRI |
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| Up to 24 months |
| Histologic failure | The proportion of patients with clinically significant disease on targeted +/- systematic biopsy at 12 months. Clinically significant disease is defined as Gleason grade group 2 or higher. It is measured using scale Grade Group 1, 2, 3, and 4. | At 12 months |
| Multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging and Reporting and Data System (PI-RADS) version 2 score for each visible lesion | These data will also be collected at 24 months post-initial treatment, for patients who receive repeat TULSA procedure. Findings from for-cause mpMRI will also be captured using Pi-Rads 1-5, 1 being most likely not cancer to 5 being very suspicious. | At 24 months post-treatment |
| Total prostate volume | These data will also be collected at 24 months post-initial treatment, for patients who receive repeat TULSA procedure. Findings from for-cause mpMRI will also be captured. | At 24 months post-treatment |
| Salvage-free survival | Will be estimated using the Kaplan-Meier method. | Up to 24 months |
| Biochemical failure-free survival | Will be estimated using the Kaplan-Meier method. | Up to 24 months |
| Histologic failure-free survival | Will be estimated using the Kaplan-Meier method. | Up to 24 months |
| Metastasis-free survival | Will be estimated using the Kaplan-Meier method. | Up to 24 months |
| Prostate cancer-specific survival | Will be estimated using the Kaplan-Meier method. | Up to 24 months |
| Overall survival | Will be estimated using the Kaplan-Meier method. | Up to 24 months |
| Change in quality of life | Change from baseline in the EPIC questions 1-7 domains and in the visual analog score will be measured at baseline, 6, 12, 18, and 24 months using Scale Grade Group 1, 2, 3, and 4. | Baseline up to 24 months |
| Change in patient-reported genitourinary function | Change from baseline in the EPIC questions 8-21 will be measured using Scale Grade Group 1, 2, 3, and 4. | Baseline up to 24 months |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D003558 | Cystoscopy |
| D001706 | Biopsy |
| D043425 | Glutamate Carboxypeptidase II |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D013048 | Specimen Handling |
| D008919 | Investigative Techniques |
| D002268 | Carboxypeptidases |
| D020689 | Exopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045727 | Metalloexopeptidases |
| D045726 | Metalloproteases |
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