A Study of Focal Salvage High-Dose-Rate Brachytherapy for Prostate Gland Only Recurrence

Launched by UNIVERSITY OF ROCHESTER · Nov 22, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called high-dose-rate (HDR) brachytherapy for men with prostate cancer that has come back after previous treatments. The goal is to understand how effective this method is in targeting and treating cancer that has recurred specifically in the prostate gland, as seen on a special type of imaging called an AXUMIN PET scan.

To participate in this trial, you need to be a man aged 18 or older who has been treated for localized prostate cancer at least two years ago, and your scans must show that the cancer has returned within the prostate. You should also be able to undergo the treatment safely and understand the information provided to you. If you join the trial, you can expect to receive HDR brachytherapy and be monitored closely for its effects on your cancer. It’s important to know that this trial is currently recruiting participants, so if you meet the criteria and are interested, you can discuss it with your healthcare provider for more details.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • History of histologically confirmed, clinically localized adenocarcinoma of the prostate treated with external beam radiation, brachytherapy, or combination of external beam radiation and brachytherapy, with curative intent completed at least 24 months ago F-18 fluciclovine (AXUMIN) PET scan within 90 days prior to registration demonstrating recurrent lesion within the prostate gland Biopsy confirmation of disease recurrence within the prostate gland Age ≥ 18 KPS ≥ 70% Suitable candidate for brachytherapy based on established criteria IPSS score \<16 No pelvic arch interference No Rectal fistula/fissure Fit for general or spinal anesthesia No history of urethral stricture Ability to understand, and willingness to sign the written informed consent
• Exclusion Criteria:
• • Evidence of metastatic or nodal disease outside of the prostate gland on AXUMIN PET scan within 90 days prior to enrollment Patient unable to have MRI Patients with neuroendocrine or small cell carcinoma of the prostate TURP within 6 months prior to enrollment History of Crohn's disease, ulcerative colitis, or known radiation proctitis Inability to understand spoken and written English