Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Undergo MRI-Guided TULSA
OTHERQuestionnaire Administration
Ancillary studies
PROCEDUREDigital Rectal Examination
Undergo DRE
PROCEDURECystoscopy
Undergo cystoscopy
PROCEDUREBiopsy
Undergo biopsy
PROCEDUREBone Scan
Undergo bone scan
PROCEDUREPSMA PET Scan
Undergo PSMA PET
Undergo mpMRI
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male * Age 45-80 years, with \> 10 years life expectancy * Biopsy-confirmed, NCCN \[Gleason Grade (GG) 1, favorable GG 2 and unfavorable GG3\] intermediate-risk prostate cancer * Stage =\< T2c, N0, M0 * International Society of Urological Pathology (ISUP) grade group 1, 2, or 3 disease on transrectal ultrasonography (TRUS)-guided biopsy (minimum 8 cores, combination of systematic and MRI fusion-guided) or in-bore biopsy \[minimum 3 cores from each Prostate Imaging-Reporting and Data System (PI-RADS) version (v)2 category \>= 3 lesion\]. Biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline * Prostate specific antigen (PSA) =\< 20 ng/mL reported within 3 months of baseline * Treatment naive * Planned ablation volume \< 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline
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) * Criteria subject to additional review and approval by sponsor. Alternatively, prospective TRUS to query calcifications or susceptibility-weighted MRI if available may be used to assess calcification. Imaging for calcification screening must be dated within 1 year of baseline visit * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients free from treatment failure | At 24 months post-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. |
| Proportion of patients who maintain both urinary continence and erectile potency | At 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histologic failure | At 12 months | 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. |
| Multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging and Reporting and Data System (PI-RADS) version 2 score for each visible lesion | At 24 months post-treatment | 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. |
| Total prostate volume | At 24 months post-treatment | 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. |
| Salvage-free survival | Up to 24 months | Will be estimated using the Kaplan-Meier method. |
| Biochemical failure-free survival | Up to 24 months | Will be estimated using the Kaplan-Meier method. |
| Change in patient-reported genitourinary function | Baseline up to 24 months | Change from baseline in the EPIC questions 8-21 will be measured using Scale Grade Group 1, 2, 3, and 4. |
| Metastasis-free survival | Up to 24 months | Will be estimated using the Kaplan-Meier method. |
| Prostate cancer-specific survival | Up to 24 months | Will be estimated using the Kaplan-Meier method. |
| Overall survival | Up to 24 months | Will be estimated using the Kaplan-Meier method. |
| Change in quality of life | Baseline up to 24 months | 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. |
| Histologic failure-free survival | Up to 24 months | Will be estimated using the Kaplan-Meier method. |
| Biochemical failure | Up to 24 months | 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. |
Countries
United States
Contacts
Primary ContactClinical Trials Referral Office
Outcome results
None listed