Focal Cryoablation for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Overseen byJustin Gregg, MD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Gleason grade 4 or 5, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
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
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.
12345Is 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.
56789How 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.
47101112Eligibility 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
+14 more
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)
+5 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Focal therapy TreatmentExperimental Treatment3 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MD Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
Philanthropic SourcesCollaborator
References
AI-Based Isotherm Prediction for Focal Cryoablation of Prostate Cancer. [2023]Focal therapies have emerged as minimally invasive alternatives for patients with localized low-risk prostate cancer (PCa) and those with postradiation recurrence. Among the available focal treatment methods for PCa, cryoablation offers several technical advantages, including the visibility of the boundaries of frozen tissue on the intraprocedural images, access to anterior lesions, and the proven ability to treat postradiation recurrence. However, predicting the final volume of the frozen tissue is challenging as it depends on several patient-specific factors, such as proximity to heat sources and thermal properties of the prostatic tissue.
Focal cryotherapy for prostate cancer: a contemporary literature review. [2023]To perform a comprehensive review of the contemporary literature regarding both functional and oncologic outcomes after primary focal cryotherapy for prostate cancer (PCa), providing these results as a foundation for discussing recent developments in the realm of focal therapy.
Focal Cryotherapy for Localized Prostate Cancer. [2017]To systematically review the oncological and functional outcomes of contemporary primary prostate focal cryotherapy for localized prostate cancer in the context of current developments in prostate focal therapy.
Focal prostate cryoablation: initial results show cancer control and potency preservation. [2016]Focal prostate cryoablation is the less-than-complete ablation of the gland with ice. Known tumor is ablated aggressively, whereas contralateral prostate tissue and surrounding structures are spared. This method offers targeted local cancer control aiming at sexual potency and urinary continence preservation in patients whose prostate cancer is believed to be unilateral.
Early-Medium-Term Outcomes of Primary Focal Cryotherapy to Treat Nonmetastatic Clinically Significant Prostate Cancer from a Prospective Multicentre Registry. [2020]Focal cryotherapy can be used to treat patients with clinically significant nonmetastatic prostate cancer to reduce side effects.
[Cryoablation of localized prostate cancer. Current state]. [2021]Due to continuous technical developments for more than half a century followed by better clinical results with minimal side effects, cryoablation of the prostate for localized prostate cancer has evolved as a true alternative therapeutic option in selected cases. The current version of cryoablation has almost nothing in common with those versions established in the 1960s and 1970s and further developed in the 1980s and 1990s. The present version is minimally invasive and has a high efficacy for treatment of high risk carcinomas and failure of other therapeutic modalities. Cryoablation of the prostate is indicated if there are absolute or relative contraindications for radical surgery. In salvage cases cryoablation is the therapy of choice for localized prostate cancer. Standardization of the procedure, definition of freeze-thaw cycles and structured training programs have led to this status.
Primary and salvage cryotherapy for prostate cancer. [2010]Cryotherapy is a technique to ablate tissue by local induction of extremely cold temperatures. Recently, the American Urological Association Best Practice Statement recognized cryoablation of the prostate as an established treatment option for men with newly diagnosed or radiorecurrent organ-confined prostate cancer. Emerging data suggest that, in select cases, cryoablation may have a role in focal ablation of prostate. The current state of the art of cryoablation in these applications is reviewed.
Retrospective Review of Percutaneous Image-Guided Ablation of Oligometastatic Prostate Cancer: A Single-Institution Experience. [2017]To retrospectively review and report the efficacy and safety of percutaneous image-guided ablation (cryoablation or radiofrequency ablation) in the treatment of oligometastatic prostate cancer.
Complications of cryosurgical ablation of the prostate to treat localized adenocarcinoma of the prostate. [2022]To review the complications associated with cryosurgical ablation of the prostate (CSAP) for localized adenocarcinoma of the prostate in the first 69 procedures performed at our institution.
Focal cryotherapy for prostate cancer. [2021]Focal therapy for prostate cancer has emerged an interesting concept as a less morbid option for the treatment of localized low-risk disease. Despite the growing interest in focal therapy, this approach has not yet gained sufficient popularity nor provided enough data to be discussed outside the experimental application. Herein we summarize the available data on focal cryotherapy and focus on the targets to be achieved in order to increase the applicability of focal cryotherapy to clinical practice. A cautious approach to candidate selection and generation of solid scientific data that would result in wide consensus on patient selection strategies and follow-up schemes would provide the tools necessary to take the path of focal therapy. Currently available focal cryotherapy data demonstrate excellent short-term results and a favorable quality-of-life profile. Although the future role of focal treatment is debated, a growing amount of science is generated in support of this minimally invasive approach.
Focal Cryoablation of Image-Localized Prostate Cancer. [2021]Focal cryoablation of localized prostate cancer can offer patients superior genitourinary functional outcomes in terms of preservation of urinary continence and potency compared with radical whole-gland therapy, while maintaining intermediate-term oncologic control. We present a step-by-step guide to focal cryoablation of localized prostate cancer. A patient with elevated prostate specific antigen (PSA) underwent multiparametric MRI (mpMRI) of the prostate that revealed a prostate imaging-reporting and data system (PI-RADS) four lesion. The patient subsequently had a transrectal ultrasound (TRUS)-guided MRI fusion biopsy of the target lesion as well as a systematic biopsy and was only found to have Gleason 3 + 4 prostate cancer in the 0.5 cc mpMRI target. The lesion plus a treatment margin was ablated with cryotherapy utilizing a traditional transperineal approach. Patient position, ultrasound and mpMRI image fusion, insertion of cryoablation needles, ablation of the prostate cancer lesion, and postoperative care were reviewed. Equipment used during the operation was itemized and described. This guide explores the necessary equipment, procedural steps, and tips for success when performing focal cryoablation of the prostate. The technique described represents the culmination of knowledge gathered with 30 years of experience performing cryoablation of prostate cancer. The accompanying video highlights the utilization of mpMRI and TRUS image fusion, triangulation of lethal ice around the prostate cancer lesion, and the importance of monitoring real-time ice formation with TRUS imaging. Cryoablation of prostate cancer can be applied to several clinical scenarios: partial-gland ablation, quadrant, hemiablation, focal-targeted, or whole gland in the primary or salvage settings. We present the surgical steps that are essential for effective focal ablation of image-localized prostate cancer.
Contemporary results of focal therapy for prostate cancer using cryoablation. [2016]The concept of focal therapy is rapidly evolving and gaining popularity from both physician and patient perspectives. We review the rationale, candidate selection, and results of the first clinical studies of focal cryoablation for selected patients with low volume and low- to low-moderate-risk features of prostate cancer as an alternative to whole-gland treatment. In spite of improved understanding of the tumor biology of early stage disease, we currently have limited tools to select appropriate patients with low- to low-moderate risk unifocal or unilateral prostate cancer who may be amenable to focal therapy. From a technical point, a number of ablative treatment options for focal therapy are available, with cryoablation having the most clinical experience. Recently, several reports have been published from single and multi-institutional studies that discuss focal therapy as a reasonable balance between cancer control and quality-of-life outcomes. Retrospective pathologic data from large prostatectomy series, however, do not clearly reveal valid and reproducible criteria to select appropriate candidates for focal cryoablation because of the complexity of tumorigenesis in early stage disease. At this time, a more feasible option remains hemiablation of the prostate with reasonable certainty about the absence of clinically significant cancer lesion(s) on the contralateral side of the prostate based on three-dimensional transperineal prostate biopsy mapping studies. Minimally invasive, parenchyma-preserving cryoablation can be considered as a potential feasible option in the treatment armamentarium of early stage, localized prostate cancer in appropriately selected candidates. There is a need to further test this technique in randomized, multicenter clinical trials.