Cryotherapy or HIFU for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Marc Dall'Era, MD

Must not be taking: Hormonal therapy

Disqualifiers: Metastases, Prior prostate treatment, Cardiac disease, others

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

Compensation: Varies

Number of Visits: 8

Duration: 1 day

100 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Cryotherapy or HIFU for Prostate Cancer?

Research shows that high-intensity focused ultrasound (HIFU) has been actively used for treating localized prostate cancer since the 1990s, with a 5-year biochemical survival rate of 85%. HIFU can also be used as a follow-up treatment after other therapies, and it targets specific tumor sites to reduce side effects. ^{1 2 3 4 5}

Is cryotherapy or HIFU safe for treating prostate cancer?

High-Intensity Focused Ultrasound (HIFU) for prostate cancer is generally considered safe with low side effects, preserving quality of life and potency. However, more follow-up is needed to fully validate its safety and effectiveness. Cryotherapy safety data was not specifically mentioned in the provided research. ^{4 6 7 8 9}

How is the treatment of cryotherapy or HIFU for prostate cancer different from other treatments?

Cryotherapy and high-intensity focused ultrasound (HIFU) are unique because they are minimally invasive treatments that use extreme cold or focused sound waves to destroy cancer cells in the prostate, offering an alternative to more invasive surgeries. These treatments are particularly useful for patients with localized prostate cancer or those whose cancer has returned after radiation therapy. ^{2 4 5 10 11}

What is the purpose of this trial?

This clinical trial evaluates the effectiveness of focal ablation with either focal cryotherapy or high intensity frequency ultrasound for the treatment of men with localized prostate cancer. Focal cryotherapy kills tumor cells by freezing them. High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor cells.

Research Team

Marc Dall'Era

Principal Investigator

University of California, Davis

Eligibility Criteria

This trial is for men with localized prostate cancer. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and have a diagnosis that fits the study's requirements.

Inclusion Criteria

Ability to understand and willingness to sign an informed consent form

My prostate cancer is early stage and visible on MRI with up to 3 lesions.

I am mostly active and can care for myself.

Exclusion Criteria

Any condition that would prohibit the understanding or rendering of informed consent

Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial

I cannot have general anesthesia due to health reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo focal cryotherapy or high intensity focused ultrasound

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Follow-up visits at 7-14 days and periodically for up to 3 years

Treatment Details

Interventions

• Cryosurgery
• High-Intensity Focused Ultrasound Ablation

Trial Overview The effectiveness of two treatments for localized prostate cancer is being tested: focal cryotherapy, which freezes tumor cells, and high-intensity focused ultrasound (HIFU), which uses heat to destroy them.

Participant Groups

Group I: Treatment (cryosurgery, high intensity focused ultrasound) Experimental Treatment 3 Interventions

Patients undergo focal cryotherapy or high intensity focused ultrasound on study.

Cryosurgery is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as Cryotherapy for:

• Localized prostate cancer

Approved in United States as Cryotherapy for:

• Localized prostate cancer
• Recurrent prostate cancer after radiotherapy

Approved in United Kingdom as Cryotherapy for:

• Localized prostate cancer
• Medium-risk prostate cancer
• High-risk prostate cancer

Who Is Running the Clinical Trial?

Marc Dall'Era, MD

Lead Sponsor

Trials

2

Recruited

130+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

High-intensity focused ultrasound (HIFU) has been shown to be an effective treatment for localized prostate cancer, with a 5-year biochemical survival rate of 85% based on data from an international registry.

HIFU not only destroys tissue through thermal and mechanical effects but can also be used as a salvage therapy after other treatments, and is being researched for focal therapy to minimize side effects by targeting specific tumor sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity focused ultrasound in the management of prostate cancer. Chaussy, C., Thüroff, S.[2010]

High-intensity focused ultrasound (HIFU) shows promising progression-free survival rates of 63-87% in prostate cancer patients, but the studies reviewed had a short median follow-up of only 12-24 months and lacked controlled trials or survival data.

Cryosurgery also demonstrates variable progression-free survival rates of 36-92%, but like HIFU, it lacks sufficient data to be considered a standard treatment option, and both therapies should be reserved for patients who cannot undergo established treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of HIFU and cryotherapy in prostate cancer--a review. Aus, G.[2006]

In a study of 21 patients treated with proton therapy (PT) for recurrent prostate cancer after cryosurgery or high-intensity focused ultrasound, the 3-year biochemical progression-free survival rate was 77%, indicating PT's efficacy as a salvage treatment.

The treatment had an acceptable toxicity profile, with a 3-year grade 3 toxicity rate of 17%, although some patients had pre-existing issues. Quality of life scores showed minimal changes, suggesting that PT may not significantly worsen patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Therapy as Salvage Treatment for Local Relapse of Prostate Cancer Following Cryosurgery or High-Intensity Focused Ultrasound. Holtzman, AL., Hoppe, BS., Letter, HP., et al.[2020]

Ultra-minimally invasive treatments like cryotherapy and high-intensity focused ultrasound (HIFU) for localized prostate cancer generally result in good urinary outcomes, with urinary incontinence occurring in only 0-10% of patients, mostly as a temporary issue.

Despite the positive urinary function results, there is still a lack of consensus on the best methods to assess and report urinary outcomes, highlighting the need for standardized evaluation practices in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary outcomes of new ultra-minimally invasive treatments for prostate cancers. De Cillis, S., Osman, N., Guillot-Tantay, C., et al.[2023]

High-intensity focused ultrasound (HIFU) and cryotherapy (CRYO) are emerging as promising salvage treatments for local radio-recurrent prostate cancer, showing acceptable short-term morbidity and oncological outcomes.

While these treatments have potential benefits, they also carry a higher risk of complications compared to primary therapies, highlighting the importance of careful patient selection and informed consent regarding risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity focused ultrasound and cryotherapy as salvage treatment in local radio-recurrent prostate cancer. Autran-Gomez, AM., Scarpa, RM., Chin, J.[2012]

In a study of 65 patients undergoing high-intensity focused ultrasound (HIFU) for localized prostate cancer, the procedure was generally well tolerated with no intra- or peri-operative deaths, but it had a notable overall complication rate of 49%.

While most complications were minor, the long-term rates of urinary incontinence (20%) and erectile dysfunction (77.1%) highlight the importance of informing patients about potential risks related to continence and sexual function before treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transrectal high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer: review of technical incidents and morbidity after 5 years of use. Ripert, T., Azémar, MD., Ménard, J., et al.[2010]

High-intensity focused ultrasound (HIFU) is a promising focal therapy for localized prostate cancer, offering effective treatment with minimal side effects and preserving patients' quality of life and potency.

Three HIFU devices (Sonablate™, Ablatherm™, and FocalOne™) are currently approved for use, and while initial oncologic results are satisfactory, further follow-up is needed to confirm long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Focal Therapy with High-Intensity Focused Ultrasound in the Management of Clinically Localized Prostate Cancer. Kuru, TH., van Essen, J., Pfister, D., et al.[2015]

In a study of 29 patients with localized prostate cancer treated with high-intensity focused ultrasound (HIFU), the failure-free survival rate was 62%, indicating that a significant number of patients experienced cancer progression within two years after treatment.

Despite low adverse events, with 70% of patients maintaining erectile function and 97% retaining urinary continence, the high progression rate (37.93%) led to the decision to discontinue HIFU treatment in the department due to concerns about its oncological safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-center, prospective phase 2 trial of high-intensity focused ultrasound (HIFU) in patients with unilateral localized prostate cancer: good functional results but oncologically not as safe as expected. Duwe, G., Boehm, K., Haack, M., et al.[2023]

In a study of 98 men with localized prostate cancer treated with High Intensity Focused Ultrasound (HIFU), 35.7% experienced minor adverse events within the first 30 days, primarily urinary tract infections and urinary retention, indicating that while HIFU is generally safe, some patients may face complications.

The study found that including the urethra in the treatment area significantly increased the risk of early complications, suggesting that careful planning to avoid this area could improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective multicentre study using high intensity focused ultrasound (HIFU) for the focal treatment of prostate cancer: Safety outcomes and complications. Schmid, FA., Schindele, D., Mortezavi, A., et al.[2021]

Focal therapy for localized prostate cancer, including methods like cryotherapy and high-intensity focused ultrasound (HIFU), shows promising results in improving quality of life and preserving urinary and erectile function.

However, the interpretation of oncological outcomes is complicated by differences in patient selection and the short duration of follow-up in studies, making it difficult to draw definitive conclusions about long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ablation energies for focal treatment of prostate cancer. Lodeizen, O., de Bruin, M., Eggener, S., et al.[2020]

Whole-gland high-intensity focused ultrasound (HIFU) demonstrated effective long-term cancer control in low- and intermediate-risk prostate cancer patients, with cancer-specific survival rates of 95% for low-risk and 89% for intermediate-risk patients at 15 years.

However, high-risk patients showed significantly poorer outcomes, indicating that HIFU should not be routinely used for this group due to inferior long-term cancer control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncological Long-term Outcome After Whole-gland High-intensity Focused Ultrasound for Prostate Cancer-21-yr Follow-up. Bründl, J., Osberghaus, V., Zeman, F., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

High-intensity focused ultrasound in the management of prostate cancer. [2010]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Current status of HIFU and cryotherapy in prostate cancer--a review. [2006]

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

Proton Therapy as Salvage Treatment for Local Relapse of Prostate Cancer Following Cryosurgery or High-Intensity Focused Ultrasound. [2020]

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

Urinary outcomes of new ultra-minimally invasive treatments for prostate cancers. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

High-intensity focused ultrasound and cryotherapy as salvage treatment in local radio-recurrent prostate cancer. [2012]

6. England pubmed.ncbi.nlm.nih.gov

Transrectal high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer: review of technical incidents and morbidity after 5 years of use. [2010]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Role of Focal Therapy with High-Intensity Focused Ultrasound in the Management of Clinically Localized Prostate Cancer. [2015]

8. Germany pubmed.ncbi.nlm.nih.gov

Single-center, prospective phase 2 trial of high-intensity focused ultrasound (HIFU) in patients with unilateral localized prostate cancer: good functional results but oncologically not as safe as expected. [2023]

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

Prospective multicentre study using high intensity focused ultrasound (HIFU) for the focal treatment of prostate cancer: Safety outcomes and complications. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Ablation energies for focal treatment of prostate cancer. [2020]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Oncological Long-term Outcome After Whole-gland High-intensity Focused Ultrasound for Prostate Cancer-21-yr Follow-up. [2022]