This phase I/II trial tests the safety and effectiveness of high-dose rate (HDR) brachytherapy boost with stereotactic radiation body therapy (SBRT) to the prostate and pelvic lymph nodes for treating patients with unfavorable intermediate or higher risk prostate cancer. HDR brachytherapy, also known as internal radiation therapy, uses high doses of radioactive material placed directly into or near a tumor to kill tumor cells. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. HDR brachytherapy boost with SBRT may be a safe and effective approach in the treatment of patients with unfavorable intermediate or higher risk prostate cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT05754580.
Locations matching your search criteria
United States
Nebraska
Omaha
University of Nebraska Medical CenterStatus: Active
Contact: Michael J Baine
Phone: 402-552-7203
PRIMARY OBJECTIVE:
I. To evaluate acute toxicity of SBRT and HDR brachytherapy boost occurring between the start of treatment up to 6 months post-radiation treatment.
SECONDARY OBJECTIVES:
I. To evaluate patient reported symptoms outcomes of SBRT and HDR brachytherapy boost occurring between the start of treatment up to 6 months post-radiation treatment.
II. To evaluate biochemical progression free survival (bPFS) of ≥ unfavorable intermediate prostate cancer patients treated with SBRT and HDR brachytherapy boost.
III. To evaluate the chronic toxicity and patient reported symptom outcomes of SBRT and HDR brachytherapy boost occurring between 6 and 28 months post-radiation treatment.
IV. To evaluate local control (LC), locoregional control (LRC), distant metastasis (DM), and overall survival (OS).
OUTLINE:
Patients undergo HDR brachytherapy boost for 1 fraction and then within 3 weeks of HDR completion, patients undergo SBRT to the prostate, seminal vesicles, and regional lymphatics for 5 fractions every other day on study. Patients also undergo magnetic resonance imaging (MRI) and/or computed tomography (CT) and bone scan or prostate specific membrane antigen (PSMA) positron emission tomography (PET) during screening as well as a transrectal ultrasound (TRUS) on study.
Upon completion of study treatment, patients are followed up after 1 month, 4 months, and then every 6 months for up to 28 months.
Lead OrganizationUniversity of Nebraska Medical Center
Principal InvestigatorMichael J Baine