Focal cryotherapy for treating intermediate risk prostate cancer

An Evidence-Based Focal Cryotherapy Protocol for Focal Ablation of Intermediate Risk Prostate Cancer

This study is testing if a new treatment called focal cryotherapy can effectively target and treat localized prostate cancer in men while also looking at how it affects their quality of life.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: M.D. Anderson Cancer Center (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05454488 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of focal cryotherapy in treating localized prostate cancer by targeting only the cancerous part of the prostate. The primary objective is to measure the negative in-field recurrence rate at six months post-ablation. Secondary objectives include assessing quality of life, PSA kinetics, out-of-field recurrence rates, MRI findings, and financial toxicity associated with the treatment. The study will involve adult males with histologically confirmed adenocarcinoma of the prostate and will utilize validated questionnaires to gather comprehensive data on patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are English-speaking adult males with organ-confined prostate cancer and a visible tumor on MRI.

Not a fit: Patients with advanced prostate cancer showing extraprostatic extension or seminal vesicle invasion may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with intermediate risk prostate cancer, potentially improving their quality of life.

How similar studies have performed: Other studies have shown promise with focal cryotherapy approaches, but this specific protocol is being evaluated for its unique effectiveness.

Eligibility criteria

Inclusion criteria:

* English-speaking adult males
* Life expectancy over 10 years as assessed by treating physician
* Prior to enrollment, MRI fusion biopsy of MRI-visible lesion required (as detailed below, which includes systematic biopsy cores)
* Single focus GG2 or GG3 (additional GG1 allowed up to 6mm, noting that a single focus of disease is defined as an area seen on MRI that may be biopsied multiple times using targeted biopsies and have systematic core biopsies directly adjacent to targeted cores; all of which being considered as from the same focus)

  * Histologically confirmed adenocarcinoma of prostate
  * Organ-confined prostate cancer, clinical stage ≤T2bN0M0
  * Visible tumor on MRI
  * No clear evidence or high suspicion of extraprostatic extension or seminal vesical invasion on MRI
  * Biopsy via transperineal or transrectal approach with at least 2 cores of MRI visible lesions that are PIRADS 2 or higher and 12 core systematic biopsy template (exclusion of cores from systematic template that overlap with targeted cores allowed).
  * 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.
  * Note that GGG 1 disease at sites other than ablation zone are allowed provided these are 6mm or less in size. PSA ≤15 ng/mL, or PSAD \<0.15 if PSA \>15 ng/mL
* Physician can fully visualize the prostate on transrectal ultrasound on entry biopsy
* Lesion anatomically amenable to cryotherapy treatment based on treating physician's discretion
* Willing and able to read, understand and sign the study specific informed consent document
* Willing and agreeable to comply with study protocol requirements, including focal cryotherapy ablation and all follow up visit requirements
* Patients must consent to investigative laboratory protocol (such as, but not limited to, 2021- 0560)

Exclusion criteria:

* Gleason grade group 4 or 5 disease
* Medical history or concurrent disease, which in the opinion of the investigator, poses the patient at significant peri-operative risk of complication due to anesthesia or the procedure
* Active urinary tract infection
* Any previous treatment for prostate cancer, including radiation therapy, hormonal treatment, biologic therapy for prostate cancer, or chemotherapy
* Prior TURP or other prostate outlet procedure such as HoLEP, greenlight, microwave ablation, aquablation, UroLift, or simple prostatectomy.
* Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease
* Inability to obtain prostate MRI (ex. due to claustrophobia, pacemaker, or prohibitive implants)
* Unwilling to consent to laboratory investigative protocol (such as, but not limited to, 2021- 0560)

Where this trial is running

Houston, Texas

• MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Justin Gregg, MD — [e-mail]
• Study coordinator: Justin Gregg, MD

Conditions: Prostate Cancer