RECRUITING

High Intensity Focused Ultrasound in Prostate Cancer

Conditions

Prostate Cancer high intensity focused ultrasound focal therapy

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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

This study will investigate the efficacy of focal high intensity focused ultrasound (HIFU) in patients with localized radiorecurrent prostate cancer. This study will also investigate the change in participant quality of life after HIFU therapy as compared to before HIFU therapy.

Official Title

Salvage Focal Therapy Via High Intensity Focused Ultrasound (HIFU) in Radiorecurrent Localized Prostate Cancer

Quick Facts

Study Start:2025-04

Study Completion:2029-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06402357

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
* Patient has elected to undergo focal high intensity focused ultrasound therapy for radiorecurrent prostate cancer * Males who are ≥ 18 years of age * Eastern Cooperative Oncology Group Performance Status of 0-3 * A history of prostate cancer treated with radiation therapy +/- hormone therapy * MRI or prostate-specific membrane antigen (PSMA) PET region of interest (ROI) * Biopsy proven clinically significant prostate cancer (GG2 or above) recurrence within or ipsilateral to the ROI lesion (within 6 months of the MRI/PET). * Contralateral grade group 1 (GG1) prostate cancer disease to the ROI * PSMA PET negative for metastatic disease (within 6 months of the biopsy) * Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician and approved by the PI\] may be included). * Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.	* Contraindication to high intensity focused ultrasound (latex allergy, absent rectum, prior rectal fistula or significant rectal surgery making insertion of transrectal probe non-feasible or dangerous.) * Hormone therapy within 6 months of the screening period (Hormone therapy includes oral (relugolix, abiraterone, enzalutamide, apalutamide, darolutamide, casodex) injections (firmagon, Lupron)) * History of Inflammatory Bowel Disease actively treated in last 3 years * Evidence of ≥ cT3 recurrent disease on imaging * Bilateral clinically significant prostate cancer (≥GG2 bilaterally) * GG1 prostate cancer at relapse biopsy (this will not be considered clinically significant prostate cancer) * Presence of brachytherapy seeds still implanted * Presence of fiduciary markers which directly impede the successful treatment of the lesion of concern, as decided upon by the surgeon upon review of imaging * Large Calcification on CT or transrectal ultrasound which, as per the review of the surgeon, limits or hinders a quality high intensity focused ultrasound to the region of interest * Urethral stricture disease that has been active over the last 6 months or required further treatment than clean intermittent catheterization * No prior radiation therapy for prostate cancer * Subjects without a ROI on MRI or PET * Metastatic disease or locally advanced disease (defined by pelvic lymph node involvement or T4 disease) on PSMA PET * History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician. * Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Inclusion Criteria

Exclusion Criteria

* Patient has elected to undergo focal high intensity focused ultrasound therapy for radiorecurrent prostate cancer
* Males who are ≥ 18 years of age
* Eastern Cooperative Oncology Group Performance Status of 0-3
* A history of prostate cancer treated with radiation therapy +/- hormone therapy
* MRI or prostate-specific membrane antigen (PSMA) PET region of interest (ROI)
* Biopsy proven clinically significant prostate cancer (GG2 or above) recurrence within or ipsilateral to the ROI lesion (within 6 months of the MRI/PET).
* Contralateral grade group 1 (GG1) prostate cancer disease to the ROI
* PSMA PET negative for metastatic disease (within 6 months of the biopsy)
* Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician and approved by the PI\] may be included).
* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.

* Contraindication to high intensity focused ultrasound (latex allergy, absent rectum, prior rectal fistula or significant rectal surgery making insertion of transrectal probe non-feasible or dangerous.)
* Hormone therapy within 6 months of the screening period (Hormone therapy includes oral (relugolix, abiraterone, enzalutamide, apalutamide, darolutamide, casodex) injections (firmagon, Lupron))
* History of Inflammatory Bowel Disease actively treated in last 3 years
* Evidence of ≥ cT3 recurrent disease on imaging
* Bilateral clinically significant prostate cancer (≥GG2 bilaterally)
* GG1 prostate cancer at relapse biopsy (this will not be considered clinically significant prostate cancer)
* Presence of brachytherapy seeds still implanted
* Presence of fiduciary markers which directly impede the successful treatment of the lesion of concern, as decided upon by the surgeon upon review of imaging
* Large Calcification on CT or transrectal ultrasound which, as per the review of the surgeon, limits or hinders a quality high intensity focused ultrasound to the region of interest
* Urethral stricture disease that has been active over the last 6 months or required further treatment than clean intermittent catheterization
* No prior radiation therapy for prostate cancer
* Subjects without a ROI on MRI or PET
* Metastatic disease or locally advanced disease (defined by pelvic lymph node involvement or T4 disease) on PSMA PET
* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Contacts and Locations

Study Contact

Priya Gurjar

CONTACT

352-273-6772

PMO@cancer.ufl.edu

Principal Investigator

Tarik Benidir, MD

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

University of Florida

Gainesville, Florida, 32608

United States

Collaborators and Investigators

Sponsor: University of Florida

Tarik Benidir, MD, PRINCIPAL_INVESTIGATOR, University of Florida

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 Date2025-04

Study Completion Date2029-08

Study Record Updates

Study Start Date2025-04

Study Completion Date2029-08

Terms related to this study

Keywords Provided by Researchers

prostate cancer
high intensity focused ultrasound
focal therapy

Additional Relevant MeSH Terms

Prostate Cancer