High Intensity Focused Ultrasound in Prostate Cancer

Launched by UNIVERSITY OF FLORIDA · May 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called high intensity focused ultrasound (HIFU) for men with localized prostate cancer that has returned after previous radiation therapy. The goal is to see how well this treatment works and how it affects the quality of life for participants. The trial is currently recruiting men aged 18 and older who have a specific type of prostate cancer recurrence and meet certain health criteria. To be eligible, participants must have had prior radiation treatment for prostate cancer and have a biopsy that shows significant cancer recurrence.

If you or a loved one decides to participate, you can expect to undergo the HIFU treatment and then share your experiences regarding any changes in your quality of life afterward. It’s important to note that not everyone can participate; for example, men with certain health issues or those who have had recent hormone therapy may not be eligible. Participants will need to provide informed consent and agree to follow the study's procedures. This trial aims to better understand HIFU as a potential treatment option for prostate cancer.

Gender

MALE

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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
• • 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.