Localized Low-Intermediate Risk Prostate Cancer Clinical Trial
Official title:
Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study
| NCT number | NCT01226576 |
| Other study ID # | PCa004 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 2010 |
| Est. completion date | December 2018 |
| Verified date | March 2019 |
| Source | InSightec |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The hypothesis of this feasibility study is that focal treatment with ExAblate MRgFUS has the
potential to be a safe and effective non-invasive treatment for low to intermediate risk,
organ-confined prostate cancer involving 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.
Based on the result of this study, InSightec will initiate a larger study in an effort to
approve low risk, organ-confined prostate cancer as an indication for its ExAblate MRgFUS
device.
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | December 2018 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 50 Years to 75 Years |
| Eligibility |
Inclusion Criteria: 1. Patient of age between 50 to 75 years, inclusive. 2. Biopsy confirmed adenocarcinoma of the prostate, performed up to 6 months prior to scheduled treatment. 3. Patient with low-intermediate risk, early-stage organ-confined prostate cancer (cT1c and cT2a, N0, M0), diagnosed with TRUS guided transperineal biopsy (TPBx) and voluntarily chooses MRgFUS as the non-invasive treatment, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy. 4. Patient with PSA less than or equal to 10 ng/mL 5. Gleason score 6 or 7 (no 5 grades), based on TRUS guided Transperineal Mapping Biopsy, as defined in the protocol. 6. Up to two (2) cancerous lesions may be identified in the prostate; each tumor is not more than 10 mm in maximal linear dimension; each tumor should comply with the maximal 7 Gleason score requirement. 7. Positive TRUS-guided transperineal biopsy (TPBx) cores, detected in a maximum of four (4) sectors, (2 for each cancerous focus) out of 16 sectors (or out of 12 sectors in prostates with volume <20 cc) 8. Low grade tumors may or may not be visible by multi-parametric MRI. Thus, in case of MRI-visible tumor, tumor should be in capsular contact of less than 5 mm, on axial images. 9. No definite evidence of extracapsular extension or seminal invasion by MRI 10. Patient eligible for epidural anesthesia, and general anesthesia (in case of complication, requiring intervention). 11. Patient is willing and able to give consent and attend all study visits as defined in the protocol 12. Prostate gland volume should be no greater than 70 cc, volumetrically measured. Exclusion Criteria: 1. ASA status > 2 2. Contraindications to MRI 2.1. Claustrophobia 2.2. Implanted ferromagnetic materials or foreign objects 2.3. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist) 2.4. Known contraindication to utilization of MRI contrast agent 3. Severely abnormal coagulation (INR>1.5) 4. Patient with unstable cardiac status including: 4.1. Unstable angina pectoris on medication 4.2. Documented myocardial infarction within 40 days prior to enrolment 4.3. Congestive heart failure NYHA class IV 4.4. Unstable arrhythmia status, already on anti-arrhythmic drugs 5. Severe hypertension (diastolic BP > 100 on medication) 6. Severe cerebrovascular disease (multiple CVA or CVA within 6 months) 7. History of orchiectomy, PCa-specific chemotherapy, 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. 8. Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment; alpha reductase inhibitors) 9. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs.) 10. Any rectal pathology, anomaly or previous treatment, which can change acoustic properties of rectal wall or prevent safe probe insertion (e.g., fistula, stenosis, fibrosis). 11. Any spinal pathology which can prevent safe administration of epidural anesthesia 12. Identified calcification of 2 mm or more in largest diameter neighboring the rectal wall (in a distance of less than 5 mm) and interfering with the acoustic beam path. 13. Lower limb musculo-skeletal fixed deformities. 14. Prostate with multiple cystic lesions. 15. Evidence for seminal vesicle/lymph node involvement of cancer. 16. Subjects with distance of the less than 2mm margin between the tumor and the prostate capsule 17. Bladder cancer 18. Patient that had TURP procedure before 19. Urethral stricture/bladder neck contracture 20. Patient with baseline symptoms of incontinence defined as urine leak in any of the following circumstances: 20.1. Before the patient can get to the toilet 20.2. When coughing or sneezing 20.3. While being asleep 20.4. While being physically active/exercising 20.5. After finishing urinating and being dressed 20.6. Leaking for no obvious reason 21. Patient with baseline impotence scoring 17 or below in the IIEF-5 (SHIM) questionnaire 22. Active UTI 23. Prostatitis NIH categories I, II and III 24. Implant near (<1 cm) the prostate 25. Interest in future fertility 26. Current participation in another clinical investigation of a medical device or a drug or has participated in such a study within 30 days prior to study enrollment |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University Health Network | Toronto | Ontario |
| Israel | Sheba Medical Center | Tel Hashomer | |
| Italy | Sapienza University Hospital | Rome | |
| Singapore | National Cancer Center Singapore | Singapore | |
| United Kingdom | St. Mary's Hospital | London |
| Lead Sponsor | Collaborator |
|---|---|
| InSightec |
Canada, Israel, Italy, Singapore, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety and initial Effectiveness | Safety: incidence and severity of device/treatment related AEs from treatment and up to 6 months follow-up Evaluating Initial effectiveness of ExAblate MRgFUS to achieve adequate tumor control in low risk organ-confined prostate cancer patients, based on 6-mo Transperineal (TP) mapping biopsy (Bx) findings |
6 months | |
| Secondary | Safety | Incidence and severity of device/treatment related AE's from treatment and up to 24 months follow-up | 24 months | |
| Secondary | Effectiveness | Evaluating effectiveness of ExAblate MRgFUS to achieve adequate tumor control in low risk organ-confined prostate cancer patients based on periodic PSA follow-up (according to study schedule) and TPBx (Transperineal Biopsy) at two years follow-up. (TPBx will be performed between 6 and 24 months, if clinically indicated) | 24 months | |
| Secondary | Effectiveness | Assessing post-ExAblate non-perfused volume (NPV) changes from immediate post- treatment measurement to at 6 and 24 months | 24 months | |
| Secondary | QOL | Patients will complete the EPIC-SF12-AUASI questionnaire periodically during study (from baseline up to 24 months post treatment), according to study schedule, to evaluate patient function and satisfaction after prostate cancer treatment. | 24 months |