This phase 2/3 randomized trial evaluates whether dose escalation to the dominant intra-prostatic lesion (DIL) compared to whole gland dose escalation during prostate stereotactic body radiotherapy (SBRT) results in differences in genitourinary (GU) and gastrointestinal (GI) toxicities.
This is a phase 2/3 randomized clinical trial evaluating two dose escalation strategies during prostate stereotactic body radiotherapy (SBRT). A total of 186 patients with prostate adenocarcinoma will be enrolled and randomized in a 1:1 ratio to one of two treatment arms. In both arms, patients will receive 3625 cGy delivered to the planning target volume (PTV) over 5 fractions. In Arm A, patients will receive a boost to the prostate gland. In Arm B, patients will receive a boost to the dominant intra-prostatic lesion (DIL) identified on pre-treatment magnetic resonance imaging (MRI). The primary objective is to evaluate chronic genitourinary (GU) and gastrointestinal (GI) toxicities grade 2 or higher from 6 months to 2 years post-treatment using the Common Terminology Criteria for Adverse Events (CTCAE). Secondary objectives include evaluation of acute and chronic GU and GI toxicities using CTCAE, Radiation Therapy Oncology Group (RTOG), and Expanded Prostate Cancer Index Composite (EPIC) domains, as well as biochemical progression-free survival at 5 years. Participants will be followed for up to 5 years after completion of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
186
External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost
External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost to the dominant intra-prostatic lesion.
Fred & Pamela Buffet Cancer Center
Omaha, Nebraska, United States
Grade 2 or Higher Chronic Genitourinary Toxicity
Cumulative incidence of grade 2 or higher chronic genitourinary (GU) toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: From 6 months post-treatment to 2 years post-treatment
Grade 2 or Higher Chronic Gastrointestinal Toxicity
Cumulative incidence of grade 2 or higher chronic gastrointestinal (GI) toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: From 6 months post-treatment to 2 years post-treatment
Biochemical Progression-Free Survival
Time from initiation of study treatment to biochemical disease progression or death from any cause.
Time frame: From initiation of study treatment to 5 years post-treatment
Acute Gastrointestinal Toxicity
Cumulative incidence of acute gastrointestinal (GI) toxicities assessed using CTCAE, Radiation Therapy Oncology Group (RTOG), and Expanded Prostate Cancer Index Composite (EPIC) domains.
Time frame: From end of treatment to 6 months post-treatment
Acute Genitourinary Toxicity
Cumulative incidence of acute genitourinary (GU) toxicities assessed using CTCAE, RTOG, and EPIC domains.
Time frame: From end of treatment to 6 months post-treatment
Chronic Gastrointestinal Toxicity
Incidence of chronic gastrointestinal (GI) toxicities assessed using CTCAE, RTOG, and EPIC domains.
Time frame: From 6 months post-treatment to 5 years post-treatment
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Chronic Genitourinary Toxicity
Incidence of chronic genitourinary (GU) toxicities assessed using CTCAE, RTOG, and EPIC domains.
Time frame: From 6 months post-treatment to 5 years post-treatment