High-dose rate brachytherapy boost with SBRT to prostate and pelvic nodes for the initial treatment of unfavorable intermediate or higher risk prostate cancer.
Categories (click each to see list of all clinical trials associated with that category): GU (ONC), Radiation Oncology (RADONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Baine, Michael
Eligibility: https://clinicaltrials.gov/study/NCT05754580?term=NCT05754580&rank=1
Summary
Primary
To evaluate acute toxicity and patient reported symptoms outcomes of SBRT and HDR brachytherapy boost occurring
between the start of treatment up to 6 months post-treatment. To be assessed with the Common Toxicity Criteria for
Adverse Events (CTCAE) version 5, as well as the International Prostate Symptom Score (IPSS), and the International
Index of Erectile Function.
Secondary
To evaluate 24-month biochemical progression free survival (bPFS) of ≥ unfavorable intermediate prostate cancer
patients treated with SBRT and HDR brachytherapy boost. To be assessed using serial measurements of
prostate-specific antigen and using the Phoenix definition of biochemical failure (PSA nadir + 2 ng/mL for two
separate measurements).
To evaluate the chronic toxicity and patient reported symptom outcomes of SBRT and HDR brachytherapy boost
occurring between 6 months to 2-years post-treatment. To be assessed with the Common Toxicity Criteria for
Adverse Events (CTCAE) version 5, as well as the International Prostate Symptom Score (IPSS), and the International
Index of Erectile Function.
To evaluate 24-month local control (LC), locoregional control (LRC), distant metastasis (DM), and overall survival
(OS). To be assessed with physical examinations, diagnostic imaging including CT, PET/CT, and/or MRI in the event of
biochemical recurrence.