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

Trial Summary

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 data supports the effectiveness of the treatment Focal Cryoablation for Prostate Cancer?

Research shows that focal cryoablation can effectively control prostate cancer while preserving sexual function and urinary control. It is particularly beneficial for patients with localized prostate cancer, offering targeted treatment with fewer side effects. ^{1 2 3 4 5}

Is focal cryoablation for prostate cancer safe?

Focal cryoablation for prostate cancer is generally considered safe, with minimal side effects reported due to continuous technical improvements over the years. ^{5 6 7 8 9}

How does the treatment Focal Cryoablation differ from other treatments for prostate cancer?

Focal Cryoablation is unique because it targets only the cancerous part of the prostate with extreme cold, sparing the surrounding healthy tissue. This approach aims to preserve sexual function and urinary control, unlike more invasive treatments that remove or treat the entire prostate gland. ^{4 7 10 11 12}

What is the purpose of this trial?

To learn if using cryotherapy to treat only the part of the prostate known to contain cancer is effective in controlling prostate cancer

Research Team

Justin Gregg, MD

Principal Investigator

[e-mail]

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

AI-Based Isotherm Prediction for Focal Cryoablation of Prostate Cancer. [2023]

2. China pubmed.ncbi.nlm.nih.gov

Focal cryotherapy for prostate cancer: a contemporary literature review. [2023]

3. Spain pubmed.ncbi.nlm.nih.gov

Focal Cryotherapy for Localized Prostate Cancer. [2017]

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

Focal prostate cryoablation: initial results show cancer control and potency preservation. [2016]

5. Switzerland 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. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

[Cryoablation of localized prostate cancer. Current state]. [2021]

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

Primary and salvage cryotherapy for prostate cancer. [2010]

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

Retrospective Review of Percutaneous Image-Guided Ablation of Oligometastatic Prostate Cancer: A Single-Institution Experience. [2017]

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

Complications of cryosurgical ablation of the prostate to treat localized adenocarcinoma of the prostate. [2022]

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

Focal cryotherapy for prostate cancer. [2021]

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

Focal Cryoablation of Image-Localized Prostate Cancer. [2021]

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

Contemporary results of focal therapy for prostate cancer using cryoablation. [2016]