Exablate Prostate Treatment for Prostate Cancer

Not currently recruiting at 4 trial locations

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: InSightec

Must not be taking: Androgen deprivation therapy

Disqualifiers: Metastasis, Bladder cancer, UTI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for prostate cancer using the Exablate Prostate device. The researchers aim to assess the safety and effectiveness of this treatment for men with specific types of prostate cancer. It targets those diagnosed with intermediate-risk prostate cancer that hasn't spread and are considering various treatment options. This trial may suit men with biopsy-confirmed prostate cancer and visible tumors on an MRI. Participants should not have advanced cancer or be receiving certain other prostate treatments. As an unphased trial, it offers participants the chance to contribute to groundbreaking research and potentially benefit from a novel treatment approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be undergoing androgen deprivation therapy or start any new medication that affects PSA levels.

What prior data suggests that the Exablate Model 2100 device is safe for treating prostate lesions?

Research has shown that the Exablate Prostate treatment is safe for patients. This method uses high-intensity focused ultrasound, a type of sound wave treatment, and results in fewer side effects than traditional prostate cancer treatments.

In one study, over 80% of men required no further treatment after the procedure. Another study found no major side effects, and most participants remained free of significant cancer afterward. Patients also resumed normal activities soon after the procedure.

These findings suggest that the Exablate Prostate treatment is well-tolerated and effective for treating prostate issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Exablate Prostate Treatment is unique because it uses focused ultrasound technology to target and destroy prostate cancer cells without the need for invasive surgery. Unlike the standard treatments like surgery or radiation, which can have significant side effects and lengthy recovery times, this method promises a non-invasive approach with potentially fewer side effects. Researchers are excited about this treatment because it offers a precision-targeted solution that minimizes damage to surrounding healthy tissue, which could lead to quicker recovery and improved quality of life for patients.

What evidence suggests that the Exablate Prostate device is effective for prostate cancer?

Research has shown that the Exablate Prostate Treatment, which uses high-intensity focused ultrasound (HIFU), effectively treats prostate cancer. One study found that 78 out of 89 men showed no signs of significant prostate cancer in the treated area after 24 months. Another study reported that 93% of participants remained free of serious prostate cancer after treatment. HIFU is known for fewer side effects, particularly in preserving urinary and sexual functions. Overall, these studies suggest that Exablate Prostate could be a promising option for treating prostate cancer. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for men with intermediate risk, organ-confined prostate cancer (stages T1a to T2b). It's suitable for those who choose Exablate treatment, are on watchful waiting or active surveillance without needing immediate radical therapy. Participants should have a PSA level of 20ng/mL or less and confirmed adenocarcinoma of the prostate.

Inclusion Criteria

PSA less than or equal to 20ng/mL

My prostate cancer was confirmed by a biopsy.

I have prostate cancer that has not spread beyond the prostate and am considering or on a watchful approach without needing immediate major treatment.

Exclusion Criteria

My prostate cancer has spread to lymph nodes or other parts.

I am on hormone therapy for prostate cancer or have had surgery to remove my testicles.

I have conditions or implants that could affect treatment safety.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the Exablate Prostate 2100 Type-3 System for prostate lesions

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Exablate Prostate Treatment

Trial Overview The study tests the Exablate Model 2100 device (Exablate Prostate) in treating localized prostate lesions. It's a single-arm study providing access to this treatment while collecting additional safety and effectiveness data during its regulatory review process.

How Is the Trial Designed?

Group I: Exablate Treated Arm Experimental Treatment 1 Intervention

Treatment with Exablate Prostate 2100 Type-3 System

Who Is Running the Clinical Trial?

InSightec

Lead Sponsor

Trials

92

Recruited

3,800+

Dr. Maurice R. Ferré

InSightec

Chief Executive Officer

MD

Dr. Arjun Desai

InSightec

Chief Medical Officer

MD

Published Research Related to This Trial

External-beam radiotherapy (EBRT) has been effectively used for over 30 years to treat prostate adenocarcinoma, demonstrating significant improvements in cause-specific survival and freedom from PSA progression.

Recent advancements in radiation techniques have enhanced the safety and efficacy of EBRT, making it a viable treatment option for early-stage, locally advanced, and metastatic prostate cancer, while managing side effects effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External-beam radiotherapy in the management of carcinoma of the prostate. Zlotecki, RA.[2017]

Prostate cancer is a common malignancy in men over 50, primarily presenting with urinary issues, and is mostly treated effectively with prostatectomy or irradiation when localized, leading to a good prognosis.

Hormonal manipulation is the main treatment for metastatic prostate cancer, with 70-80% of patients responding to therapies like orchiectomy and LHRH analogs for up to three years, although responses diminish significantly after relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of prostate cancer. Korman, LB.[2005]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9846805/

Magnetic resonance imaging-guided ultrasound ablation ... The ExAblate 2100 Prostate ... A multicentre study of 5-year outcomes following focal therapy in treating clinically significant nonmetastatic prostate cancer.

2. mskcc.org mskcc.org/news/high-intensity-focused-ultrasound-hifu-can-control-prostate-cancer-fewer-side-effects

HIFU for Prostate Cancer: Fewer Side Effects and No ... Learn how high-intensity focused ultrasound (HIFU) can help some men with prostate cancer avoid surgery or radiation.

3. grandroundsinurology.com grandroundsinurology.com/outcomes-of-recent-clinical-trials-for-focal-therapy/

Outcomes of Recent Clinical Trials for Focal Therapy Findings reveal that HIFU achieves non-inferior outcomes regarding salvage therapy-free survival and demonstrates better urinary and erectile function ...

4. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.2021202717

MRI-guided Focused Ultrasound Ablation for Localized ... No major treatment-related adverse events occurred. Forty-one of 44 participants (93%; 95% CI: 82, 98) were free of clinically significant ...

5. auntminnie.com auntminnie.com/clinical-news/radiation-oncology-therapy/article/15631289/insightec-highlights-exablate-prostate-system-study-results

Insightec highlights Exablate Prostate system study results At 24 months, 78 of 89 men had no evidence of grade group 2 or higher prostate cancer in the treated area. No grade 4 or grade 5 treatment-related adverse ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11614176/

High-intensity focused ultrasound strategies for treating ... The findings indicated that TULSA is a safe and effective alternative to conventional treatments for prostate tissue ablation in men with primary PCa.

7. urotoday.com urotoday.com/conference-highlights/aua-2021-program/aua-2021-oab-and-lower-urinary-tract-infections/132044-aua-2021-mri-guided-focused-ultrasound-focal-therapy-for-intermediate-risk-prostate-cancer-final-results-of-a-phase-iib-multicenter-study.html

AUA 2021: MRI-guided Focused Ultrasound Focal Therapy ... Multicenter, retrospective studies have shown focal therapy for prostate cancer is safe and reported approximately 80% of men require no further ...