N/A
N=101
Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions
Localized Intermediate Risk Prostate Lesions
Bottom Line
View on ClinicalTrials.gov: NCT01657942 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Number of Device and Procedure Related Adverse Events — 24 Number of Adverse Events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ExAblate MR Guided Focused Ultrasound (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- InSightec
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Device and Procedure Related Adverse Events |
24 | — |
| PRIMARY Percentage of Subjects With NO Gleason Grade Group (GGG) Tissue in the Planned Region of Treatment (ROT) at 6 Months. |
91.1 | — |
| PRIMARY Percentage of Subjects Showing a Reduction in PSA Value (Prostate Specific Antigen) From Baseline to 6-Months |
91.1 | — |
| PRIMARY Percentage of Subjects With Non-Perfused Volume (NPV) Entirely Covered Target Gleason Grade Group (GGG) Tissue at Treatment. |
87.1 | — |
| SECONDARY Prostate Specific Antigen (PSA) |
6.4; 3.3; 3.2 | — |
| SECONDARY Functional Assessment of Cancer Therapy - General (Fact-G) Total Score |
94.8; 94.5; 94.7; 95.7; 90.2; 93.3 | — |
| SECONDARY Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score |
134.2; 134.3; 134.2; 134.3; 127.8; 131.4 | — |
| SECONDARY Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) |
89.9; 90.8; 90.3; 89.1; 86.0; 87.7 | — |
| SECONDARY International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score |
1.2; 1.5; 1.3; 2.0; 2.2; 2.1 | — |
| SECONDARY International Prostate Symptom Score (IPSS Total Score) |
8.5; 8.8; 8.6; 8.1; 8.1; 8.1 | — |
| SECONDARY International Prostate Symptom Score (IPSS) - Quality of Life Score |
1.9; 1.6; 1.8; 1.2; 1.5; 1.3 | — |
| SECONDARY International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction |
7.8; 7.0; 7.4; 6.8; 6.5; 6.7 | — |
Summary
The hypothesis of this study is that focal treatment with ExAblate MRgFUS has the potential to be an effective non-invasive treatment for intermediate risk, organ-confined prostate lesions, with a low incidence of morbidity. The study hypothesis will be tested by measuring treatment-related safety and initial effectiveness parameters in the ExAblate MRgFUS treated patients, as described above.
Eligibility Criteria
Inclusion Criteria
- Biopsy proven adenocarcinoma of the prostate (using a IMAGE-guided 14+ core mapping biopsy), and targeted cores as needed obtained up to 6 months prior to scheduled treatment
- Patient with intermediate risk, early-stage organ-confined prostate cancer (T1a up to T2b, N0, M0) and voluntarily chooses ExAblate thermal ablation as the non-invasive treatment, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy.
- Patient with PSA less than or equal to 20 ng/mL
- Gleason score 7 (4 + 3 or 3 + 4), based on mapping prostate biopsy, with no more than 15mm cancer in maximal linear dimension in any single core
- Single hemilateral index Gleason 7 lesion, identified in the prostate based on biopsy mapping with supporting MRI; may have secondary Gleason 6 lesion on ipsilateral or contralateral side confirmed with biopsy and/or MRI
Exclusion Criteria
- Contraindications to MRI
- History of orchiectomy, PCa-specific chemotherapy, brachytherapy, cryotherapy, Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; any prior radiation therapy to the pelvis for prostate cancer or any other malignancy
- Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs. sonication time)
- Any rectal pathology, anomaly or previous treatment, which could change acoustic properties of rectal wall or prevent safe probe insertion (e.g., stenosis, fibrosis, inflammatory bowel disease, etc.)
- Evidence of distant prostate cancer, i.e., including lymph nodes and/or metastasis of cancer on imaging
- Bladder cancer
- Urethral stricture/bladder neck contracture
- Prostatitis NIH categories I, II and III
- Implant near (<1 cm) the prostate
Data sourced from ClinicalTrials.gov (NCT01657942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.