Focal Cryoablation for Prostate Cancer

Overseen By Justin Gregg, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Gleason grade 4 or 5, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cryotherapy (freezing treatment) targeting only the cancerous part of the prostate can effectively control prostate cancer. The focus is on men with prostate cancer confined to the prostate and visible on an MRI scan. It suits English-speaking men diagnosed with prostate cancer that hasn't spread beyond the prostate and who haven't undergone previous treatments like surgery or radiation. Participants will undergo a procedure where needles freeze the cancerous area and must commit to follow-up visits. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What prior data suggests that focal cryoablation is safe for treating prostate cancer?

Research has shown that focal cryoablation, which uses extreme cold to destroy prostate cancer cells, is generally safe. Studies have found that patients usually tolerate this procedure well. Side effects are typically mild, and many patients experience few complications. Reviews of patient feedback also support the treatment's safety, with most patients reporting positive experiences. While results can vary, the treatment is considered safe for most individuals. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Focal cryoablation is unique because it targets prostate cancer by freezing and destroying cancer cells directly at the tumor site. Unlike traditional treatments such as surgery or radiation, which can affect nearby healthy tissue, focal cryoablation is minimally invasive and focuses specifically on the cancerous area. This precision means potentially fewer side effects and a quicker recovery time. Researchers are excited about this treatment because it offers a targeted approach that could maintain the effectiveness of traditional methods while improving the patient's quality of life.

What evidence suggests that focal cryoablation is effective for prostate cancer?

Research has shown that focal cryoablation, which participants in this trial may receive, is a promising method for controlling prostate cancer. Studies have found high survival rates, with 93.9% to 100% of patients not experiencing cancer spread. In some studies, 100% of patients survived without dying from prostate cancer. Overall survival rates are also strong, ranging from 96.1% to 100%. These findings suggest that focal cryoablation can effectively manage prostate cancer, especially in cases with low to intermediate risk. ^{1 2 4 6 7}

Who Is on the Research Team?

Justin Gregg, MD

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

Men with intermediate-risk prostate cancer who have a single focus of disease visible on MRI and confirmed by biopsy, without evidence of spread beyond the prostate. They must be able to undergo MRI, have not had previous treatments for prostate cancer or certain prostate surgeries, and are willing to follow study procedures.

Inclusion Criteria

Your doctor thinks that your injury can be treated with cryotherapy.

Additional performance of microultrasound guided biopsy is allowed though not required. Please note that every effort will be made to correlate microultrasound findings with MRI, in order to determine if positive results are from the same MRIvisible focus. This determination will be made by the surgeon performing the biopsy.

Physician can fully visualize the prostate on transrectal ultrasound on entry biopsy

Exclusion Criteria

You have undergone a prostate procedure in the past, such as TURP or other treatments to improve urine flow.

Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease

Unwilling to consent to laboratory investigative protocol (such as, but not limited to, 2021- 0560)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo focal cryotherapy ablation targeting the prostate cancer site

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and quality of life post-treatment

6 months

Regular visits for assessments and questionnaires

Long-term follow-up

Participants are monitored for progression and re-intervention as part of standard care

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Focal Cryoablation
• Standard of Care

Trial Overview The trial is testing focal cryotherapy, which freezes only the part of the prostate with cancer. It's compared against standard care. Participants will also complete quality-of-life questionnaires to assess how treatments affect their well-being.

How Is the Trial Designed?

Group I: Focal therapy Treatment Experimental Treatment 3 Interventions

Cryoablation is a procedure in which special needles are inserted into the tumor site.

Focal Cryoablation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Focal Cryoablation for:

• Prostate cancer

Approved in United States as Focal Cryoablation for:

• Prostate cancer
• Localized prostate cancer
• Intermediate risk prostate cancer

Approved in Canada as Focal Cryoablation for:

• Prostate cancer

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Philanthropic Sources

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

In a review of 69 cryosurgical ablation procedures for prostate cancer involving 63 patients, 59% experienced significant complications, including urinary retention and incontinence, but there were no deaths or transfusions required.

The complication rate increased over time, particularly after the discontinuation of an investigational urethral warmer, highlighting the need for careful management and patient awareness regarding the potential for serious side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of cryosurgical ablation of the prostate to treat localized adenocarcinoma of the prostate. Cox, RL., Crawford, ED.[2022]

Cryotherapy, which uses extremely cold temperatures to destroy tissue, has been recognized by the American Urological Association as an effective treatment for men with newly diagnosed or recurrent prostate cancer confined to the organ.

Recent studies suggest that cryoablation may also be beneficial for targeted treatment of specific areas within the prostate, indicating its potential for more focused cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary and salvage cryotherapy for prostate cancer. Finley, DS., Pouliot, F., Miller, DC., et al.[2010]

In a study of 31 men with unilateral prostate cancer, focal cryoablation achieved a high biochemical disease-free status of 92.8% and a negative biopsy rate of 96.0% after a mean follow-up of 70 months, indicating effective local cancer control.

The procedure also preserved sexual potency in 48.1% of patients, with an additional 40.7% maintaining potency with medication, resulting in an overall potency-preservation rate of 88.9%, and no complications were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal prostate cryoablation: initial results show cancer control and potency preservation. Bahn, DK., Silverman, P., Lee, F., et al.[2016]

A convolutional neural network model was developed to accurately predict the boundaries of frozen tissue (iceball) during cryoablation for prostate cancer, using data from 38 cases, which showed a significant improvement in prediction accuracy compared to traditional geometrical models.

The proposed model achieved a mean Dice Similarity Coefficient of 0.79, indicating high accuracy in predicting iceball boundaries in under 0.4 seconds, suggesting its potential for real-time use in clinical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AI-Based Isotherm Prediction for Focal Cryoablation of Prostate Cancer. Moreira, P., Tuncali, K., Tempany, C., et al.[2023]

Primary focal cryoablation for prostate cancer shows promising functional outcomes and a favorable safety profile, making it a viable alternative to traditional treatments that often have debilitating side effects.

While short- to medium-term oncologic outcomes appear adequate, the lack of long-term follow-up and variability in clinical endpoints makes it difficult to fully assess the effectiveness of this treatment over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal cryotherapy for prostate cancer: a contemporary literature review. Kotamarti, S., Polascik, TJ.[2023]

Focal cryotherapy for localized prostate cancer shows promising oncological outcomes, with a biochemical progression-free survival (BPFS) rate ranging from 71% to 98% and a low post-treatment positive biopsy rate of 8-25% among 1,595 men studied.

The treatment is safe, with high rates of continence (96-100%) and low rates of erectile dysfunction (0-42%) and urinary retention (0-15%), indicating good preservation of sexual and urinary function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal Cryotherapy for Localized Prostate Cancer. Tay, KJ., Polascik, TJ.[2017]

Focal cryoablation of localized prostate cancer offers better preservation of urinary continence and potency compared to traditional radical whole-gland therapy, while still providing effective cancer control in the intermediate term.

The procedure involves advanced imaging techniques like mpMRI and TRUS for precise targeting and monitoring, and is supported by 30 years of experience in cryoablation, making it a reliable option for various clinical scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal Cryoablation of Image-Localized Prostate Cancer. Arcot, R., Potts, BA., Polascik, TJ.[2021]

Focal cryoablation is emerging as a promising treatment for patients with low-volume, low- to low-moderate-risk prostate cancer, offering a balance between effective cancer control and improved quality of life compared to whole-gland treatments.

Current studies suggest that while focal cryoablation shows potential, there is still a need for better patient selection criteria and further validation through randomized, multicenter clinical trials to ensure its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary results of focal therapy for prostate cancer using cryoablation. Mouraviev, V., Johansen, TE., Polascik, TJ.[2016]

In a study of 122 patients with medium- to high-risk prostate cancer treated with focal cryotherapy, the 3-year failure-free survival rate was approximately 90%, indicating effective cancer control.

The treatment resulted in very low rates of side effects, with no patients experiencing incontinence and only 16.1% reporting erectile dysfunction, highlighting its safety and tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early-Medium-Term Outcomes of Primary Focal Cryotherapy to Treat Nonmetastatic Clinically Significant Prostate Cancer from a Prospective Multicentre Registry. Shah, TT., Peters, M., Eldred-Evans, D., et al.[2020]

Focal cryotherapy for prostate cancer shows promising short-term results and a favorable quality-of-life profile, making it a less invasive option for treating localized low-risk disease.

To increase the acceptance of focal therapy in clinical practice, there is a need for careful patient selection and robust scientific data to establish consensus on treatment strategies and follow-up protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal cryotherapy for prostate cancer. Tsivian, M., Polascik, TJ.[2021]

Percutaneous image-guided ablation (either cryoablation or radiofrequency ablation) achieved local tumor control in 83% of metastatic sites in 16 patients with oligometastatic prostate cancer, with a median follow-up of 27 months.

The procedure was well tolerated with no major complications, and it was particularly effective in delaying androgen-deprivation therapy (ADT) in 7 ADT-naïve patients, who experienced a median ADT-free survival of 29 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Review of Percutaneous Image-Guided Ablation of Oligometastatic Prostate Cancer: A Single-Institution Experience. Erie, AJ., Morris, JM., Welch, BT., et al.[2017]

Cryoablation of the prostate has become a highly effective and minimally invasive treatment option for localized prostate cancer, especially in high-risk cases or when other treatments have failed.

Recent advancements and standardization in cryoablation techniques have significantly improved clinical outcomes and reduced side effects compared to earlier methods used in the 1960s to 1990s.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cryoablation of localized prostate cancer. Current state]. Witzsch, UK., Becht, E.[2021]

Citations

1. 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.

2. 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).

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

Review article Advances in focal therapy for prostate cancer Long-term outcomes of focal cryotherapy for low- to intermediate-risk prostate cancer: results and matched pair analysis with active ...

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

Established focal therapy—HIFU, IRE, or cryotherapy— ... Functional outcomes and safety of focal therapy for prostate cancer: a systematic review on results and patient-reported outcome measures (PROMs).

5. 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 ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2287888225000406

Multimodality focal therapy for prostate cancer: outcome of ... Clinically significant recurrence (International Society of Urological Pathology grade group: ≥2) were found in 7 patients (11.1%). Subsequent ...

7. cancer.gov cancer.gov/clinicaltrials/NCI-2023-09811

Focal Ablation with Focal Cryotherapy or High Intensity ... This clinical trial evaluates the effectiveness and safety of focal therapy (focal cryotherapy or high intensity frequency ultrasound) for the treatment of ...