The objective of this phase I/II trial is to prospectively evaluate the toxicity and therapeutic efficacy of Stereostatic Body Radiation Therapy (SBRT) to prostate and pelvic lymph nodes in combination with high-dose-rate (HDR) brachytherapy to the prostate in patients with localized unfavorable-intermediate risk or higher disease.
Currently the practice of minimizing monetary and human costs of therapy in the field of oncology is in vogue. As such, there has been heightened interest in the ability to decrease the total number and duration of radiation therapy treatments via brachytherapy and stereotactic body radiation therapy (SBRT). With this, the use of SBRT has been increasingly utilized for elective nodal irradiation (ENI) to treat patients with intermediate-risk prostate cancer or higher to improve biochemical progression free survival (bPFS). However, there is a dearth of studies assessing the efficacy and toxicity profile of these two modalities in combination. The objective of this phase I/II trial is to prospectively evaluate the toxicity and therapeutic efficacy of SBRT to prostate and pelvic lymph nodes in combination with high-dose-rate (HDR) brachytherapy to the prostate in patients with localized unfavorable-intermediate risk or higher disease. We hypothesize that this combination therapy will have an acceptable toxicity profile and that ENI via SBRT will provide improved bPFS compared to no nodal treatment and synonymous with conventional fractionation. The sample size will be 53 patients, with biopsy confirmed unfavorable-intermediate or higher risk prostate cancer and ≥ 15% probability of nodal involvement as determined by publicly available nomograms. Eligible patients will undergo ultrasound-guided HDR brachytherapy to the whole prostate to a dose of 15 Gy in 1 fractions followed by SBRT to a dose of 25 Gy in 5 fractions given every other day. Follow-up will assess toxicity and biochemical progression-free survival and subsequent comparison to historical results.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
This technique involves transient insertion of a stronger (i.e. more active) source (Ir-192) into the prostate, with dose delivery over the course of several minutes followed by immediate removal.
ultra-hypofractionation radiation therapy.
University of Nebraska Medical Center
Omaha, Nebraska, United States
RECRUITINGNumber of Participants with Treatment-Related Adverse Events
To evaluate acute GI or GU toxicity and patient reported symptoms outcomes of SBRT and HDR brachytherapy boost as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 with a scale of Grade 1 through Grade 5 with Grade 1 being mild and Grade 5 being death. The International Prostate Symptom Score (IPSS) will also be used with a scale of 1 through 35, with 1-7 being mild, 8-19 being moderate, and 20-35 being severe. And the International Index of Erectile Function Questionnaire.
Time frame: between the start of treatment up to 6 months post-treatment.
Proportion of patients with reported symptom outcomes of SBRT and HDR brachytherapy
To be assessed with the International Prostate Symptom Score (IPSS) with a scale of 0 to 35 with 0-7 being mild, 8-19 being moderate, and 20-35 being severe, and the International Index of Erectile Function (IIEF) with a scale of 5 to 25 with 5 being poor function and 25 indicating no dysfunction.
Time frame: Between the start of treatment and 6 months post-radiation treatment
Biochemical progression free survival (bPFS)
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).
Time frame: Month 4, 10, 16, 22, and 28 post-SBRT
Proportion of patients with chronic toxicity and side-effects from HDR Brachytherapy and SBRT
To be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 with a scale of Grade 1 through Grade 5 with Grade 1 being mild and Grade 5 being death. The International Prostate Symptom Score (IPSS) will also be used with a scale of 1 through 35, with 1-7 being mild, 8-19 being moderate, and 20-35 being severe. And the International Index of Erectile Function Questionnaire.
Time frame: Between 6 months to 28 months post-treatment
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Number of patients with 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.
Time frame: Through study completion, an average of 28 months after treatment