Exablate Prostate Treatment for Prostate Cancer

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

14 Participants Needed

Trial Summary

What is the purpose of this trial?

This extended clinical investigation is a multicenter, prospective, single arm study intended to provide continued access of the Exablate Model 2100 device (Exablate Prostate) to patients for treatment of prostate lesions and collect additional safety and effectiveness data during the 510(k) preparation and review period.

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.

How does Exablate Prostate Treatment differ from other prostate cancer treatments?

Exablate Prostate Treatment is unique because it uses focused ultrasound waves to target and destroy prostate cancer cells, offering a non-invasive alternative to traditional surgical or radiation therapies. This method may reduce recovery time and minimize side effects compared to more invasive treatments. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Possibilities in drug therapy in prostatic carcinoma]. [2008]

2. Germany pubmed.ncbi.nlm.nih.gov

Radiation treatment planning for the localized prostatic carcinoma: methods and rationale. [2004]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment of prostate cancer. [2005]

4. United States pubmed.ncbi.nlm.nih.gov

The geography of prostate cancer and its treatment in Europe. [2005]

5. United States pubmed.ncbi.nlm.nih.gov

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