Clinical trial NCT01657942: Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions
Official title: Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Localized Intermediate Risk Prostate Lesions
Keywords: MRgFUS
Prostate
Intermediate Risk Prostate Lesions
Focal Prostate treatment
InSightec
ExAblate
Non-invasive
Prostate cancer
Gleason 7
Lead sponsor: InSightec
Sponsor class: INDUSTRY
First posted: 2012-08-06
Enrollment: 101
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Objective of this pivotal trial is to assess safety and initial effectiveness of ExAblate MRgFUS in the treatment of intermediate risk, localized (organ confined) prostate lesions.

ExAblate treatment will be implemented as a focal lesion-selective therapy, directed at pre-defined volume(s)/sector(s) in the prostate, identified by mapping biopsy and multi-parametric MRI, rather than a whole gland or hemi-ablation treatment.

Safety: evaluate incidence and severity of adverse events associated with ExAblate's MRgFUS focal treatment of intermediate risk organ confined prostate lesions. The risk of ExAblate treatment-related incontinence and impotence will also be assessed in this study.

Effectiveness: determine the lesion control effect of ExAblate's MRgFUS focal treatment of intermediate risk organ-confined prostate lesions (confirmed by IMAGE-guided mapping biopsy results).

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

Primary outcomes:
measure: Number of Device and Procedure Related Adverse Events
timeFrame: 12 months Post Treatment
measure: Percentage of Subjects With NO Gleason Grade Group (GGG) Tissue in the Planned Region of Treatment (ROT) at 6 Months.
timeFrame: 6 Months Post Treatment
measure: Percentage of Subjects Showing a Reduction in PSA Value (Prostate Specific Antigen) From Baseline to 6-Months
timeFrame: 6-months Post Treatment
measure: Percentage of Subjects With Non-Perfused Volume (NPV) Entirely Covered Target Gleason Grade Group (GGG) Tissue at Treatment.
timeFrame: 6 Months Post Treatment
Secondary outcomes:
measure: Prostate Specific Antigen (PSA)
timeFrame: Baseline, 6 Months, 12 Months
measure: Functional Assessment of Cancer Therapy - General (Fact-G) Total Score
timeFrame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
measure: Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score
timeFrame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
measure: Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI)
timeFrame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
measure: International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score
timeFrame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
measure: International Prostate Symptom Score (IPSS Total Score)
timeFrame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
measure: International Prostate Symptom Score (IPSS) - Quality of Life Score
timeFrame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
measure: International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction
timeFrame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Delray Beach
country: United States
facility: Sperling Prostate Center
state: Florida
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Behfar Ehdaie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ehdaie B, Tempany CM, Holland F, Sjoberg DD, Kibel AS, Trinh QD, Durack JC, Akin O, Vickers AJ, Scardino PT, Sperling D, Wong JYC, Yuh B, Woodrum DA, Mynderse LA, Raman SS, Pantuck AJ, Schiffman MH, McClure TD, Sonn GA, Ghanouni P. MRI-guided focused ultrasound focal therapy for patients with intermediate-risk prostate cancer: a phase 2b, multicentre study. Lancet Oncol. 2022 Jul;23(7):910-918. doi: 10.1016/S1470-2045(22)00251-0. Epub 2022 Jun 14.