A phase I trial to determine the safety of delivering three sequentially shorter RT schedules (20, 16, and 12 fractions) of HypoFx pelvic nodal RT in combination with a HypoFx, simultaneous integrated boost (SIB) to the prostate that have been designed to incrementally increased the biological equivalent dose (BED) to prostate cancer, while maintaining a constant BED to normal tissue toxicity.
Outcomes for patients with unfavorable intermediate-risk and high-risk prostate cancer (PC) have been historically poor and are now known to require multimodality treatment. A standard non-surgical treatment option for patients with localized, intermediate and high-risk PC is radiation therapy (RT) in combination with short- or long-term androgen deprivation therapy (ADT). The benefit of pelvic nodal RT in this setting is unclear, previous studies have been equivocal. There is a growing body of evidence to demonstrate that use of hypofractionated (HypoFx) RT may be a safe method for increasing the dose of RT, while also decreasing normal tissue toxicity.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
All patients RT will be delivered utilizing pencil beam scanning proton therapy. Radiation treatment will be delivered 4 days per week.
Maryland Proton Treatment Center
Baltimore, Maryland, United States
HypoFx RT schedule that results in <33% acute dose-limiting toxicity with accelerated, HypoFx pelvic nodal RT
The frequency of all observed acute GI, GU, hematologic, and neurologic dose limiting toxicities by CTCAE v5 grade will be tabulated. DLT is defined as treatment-related: Grade ≥3 GI (small bowel or rectal) toxicity, Grade ≥3 GU toxicity, Grade ≥3 hematologic, Grade ≥3 neurologic toxicity, or any grade 5 treatment-related adverse events.
Time frame: Within 90 days of completing RT
Frequency of acute and late GI, GU, hematologic, and neurologic toxicity for each dose cohort
The frequency of the maximum grade acute (within 90 days completing RT) and late (occurring \> 90 days from treatment) GI (small bowel and rectal), GU, hematologic, and neurologic toxicities at 3-months, 6 months, 1-year and 2 years for each dose cohort using National Cancer Institute Common Terminology Criteria v.5.0 (NCI CTCAE v5).
Time frame: Acute (within 90 days completing RT), Late (occurring > 90 days from treatment), 3-months, 6 months, 1-year and 2 years
Dose volume histogram (DVH) parameters
A dose-volume histogram is a histogram relating radiation dose to tissue volume in radiation therapy planning.
Time frame: Within 90 days of completing RT
Evaluate the duration of biochemical progression-free survival
The duration of bPFS will be measured from the end of RT until either PSA recurrence or death due to any cause and summarized for the expanded cohort of patients treated at the maximum total dose (MTD). PSA recurrence is defined by the Phoenix definition of biochemical failure (PSA nadir + 2 ng/mL).
Time frame: 2 years after completing RT
Patient Reported Outcomes (PROs) related to urinary and bowel function
Quality of life will be assessed with the validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire.
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Time frame: 1 month after completion of treatment, every 3 months for year 1, and every 6 months during Year 2
Patient Reported Outcomes (PROs) related to urinary function
The International Prostate System Score (IPSS) questionnaire will be used for urinary function.
Time frame: 1 month after completion of treatment, every 3 months for year 1, and every 6 months during Year 2
Patient Reported Outcomes (PROs) related to urinary and bowel function
The PRO-CTCAE questionnaire measures patient-reported bowel, urinary and sexual function.
Time frame: 1 month after completion of treatment, every 3 months for year 1, and every 6 months during Year 2