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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to treat localized prostate cancer. Cryosurgery (also known as cryotherapy or cryoablation) uses freezing to kill cancer cells, while high-intensity focused ultrasound ablation (HIFU) uses focused sound waves to heat and destroy them. Men with prostate cancer visible on MRI scans, who haven't received prior treatment and can commit to study requirements, might be suitable candidates. The researchers aim to assess the effectiveness of these treatments in targeting cancer cells. Participants will undergo either the freezing or sound wave treatment. As an unphased trial, this study offers patients the opportunity to explore innovative treatment options for localized prostate cancer.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both cryotherapy and high-intensity focused ultrasound (HIFU) are promisingly safe for treating prostate cancer. Studies on cryotherapy indicate it is generally well-tolerated, with many patients experiencing good survival rates and avoiding further aggressive treatments for years. Serious side effects rarely occur.

Similarly, HIFU is considered a safe and minimally-invasive option. It uses sound waves to target and destroy cancer cells without radiation. Studies have shown it is effective, especially for patients with lower-risk prostate cancer. Most patients do not experience major side effects or a decrease in quality of life.

These findings suggest both treatments have good safety records, making them potential options for those considering clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about cryosurgery and high-intensity focused ultrasound (HIFU) for prostate cancer because these treatments offer a minimally invasive alternative to the standard of care, which typically includes surgery, radiation, or hormone therapy. Cryosurgery works by freezing cancer cells, which can lead to fewer side effects and a quicker recovery time compared to traditional surgery. HIFU uses precise, high-frequency sound waves to heat and destroy cancer cells without damaging surrounding tissue, offering a targeted approach with the potential for less collateral damage. These methods could provide effective treatment with reduced impact on patients' quality of life.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

This trial will compare cryotherapy and high-intensity focused ultrasound (HIFU) for treating localized prostate cancer. Research has shown that both cryotherapy and HIFU are promising treatments. Studies have found that focal cryotherapy can lead to high survival rates, with 97% of men living without cancer spreading for at least five years, and 99% surviving cancer-specific causes. This means most men treated with cryotherapy live without the cancer spreading for at least five years. For HIFU, research indicates that 85% of men do not need additional treatments within five years, suggesting it effectively controls cancer with fewer repeat treatments. Additionally, HIFU is known for helping maintain quality of life, such as better recovery of bladder control. Both treatments aim to target cancer cells while preserving as much healthy tissue as possible. ^{1 2 6 7 8}

Who Is on the Research Team?

Marc Dall'Era

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

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

I am mostly active and can care for myself.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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 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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2287888225000637

Review article Advances in focal therapy for prostate cancer Focal therapy (FT) has emerged as a promising treatment option for localized prostate cancer (PCa), offering oncologic control with reduced ...

2. nature.com nature.com/articles/s41391-024-00911-2

Established focal therapy—HIFU, IRE, or cryotherapy— ... FT with cryotherapy, HIFU, and IRE is associated with good short-intermediate term oncological and functional outcomes.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12227874/

Current Status of Cryoablation in Prostate Cancer ... The data from a systematic review included 24 papers that examined oncological outcomes of the focal cryotherapy.

4. renalandurologynews.com renalandurologynews.com/reports/prostate-cancer-focal-cryotherapy-offers-good-oncologic-outcomes/

Prostate Cancer Focal Cryotherapy Offers Good Oncologic ... Metastasis-free, cancer-specific, and overall survival rates at 5 years were 97%, 99%, and 96%, respectively. Post-ablation biopsy was performed ...

5. londonprostate.co.uk londonprostate.co.uk/areas-of-interest/cryotherapy-for-prostate-cancer/

Cryotherapy for Prostate Cancer Cryotherapy (or cryosurgery / cryoablation) is a minimally-invasive effective treatment for prostate cancer with fewer side-effects than surgery or ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405456921001140

Prostate Cancer Long-term Outcomes of Focal Cryotherapy ... Ten-year radical therapy–free or ADT-free, any treatment-free, metastasis-free, and overall survival were 51%, 40.2%, 93.9%, and 97%, respectively for FC.

7. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1534739/full

Oncological effects and complications of salvage ... Conclusions: Cryotherapy demonstrates a favorable safety profile and significant RFS benefits for salvage treatment of radio-recurrent PCa.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9906190/

Focal cryotherapy for prostate cancer When reported, metastasis-free survival (MFS), cancer-specific survival (CSS), and OS ranged from 93.9–100%, 100%, and 96.1–100%, respectively (20,21,23-25).