RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-07-25

Study Completion:2026-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05454488

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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)

Inclusion Criteria

Exclusion 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)

* 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)

Contacts and Locations

Study Contact

Justin Gregg, MD

CONTACT

713-792-3250

jrgregg@mdanderson.org

Principal Investigator

Justin Gregg, MD

PRINCIPAL_INVESTIGATOR

jrgregg@mdanderson.org

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Justin Gregg, MD, PRINCIPAL_INVESTIGATOR, jrgregg@mdanderson.org

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-25

Study Completion Date2026-01-31

Study Record Updates

Study Start Date2022-07-25

Study Completion Date2026-01-31

Terms related to this study

Additional Relevant MeSH Terms

Prostate Cancer