This is a phase II study of ultrahypofractionated whole pelvis proton therapy with brachytherapy boost for patients with high risk or unfavorable intermediate risk prostate with elevated risk of lymph node involvement.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Brachytherapy boost will be delivered and then whole pelvis proton radiation therapy in 5 fractions.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGSafety of ultrahypofractionated proton therapy with HDR brachytherapy boost
The technique will be deemed safe if \<10% of patients experience a CTCAE version 5.0 grade 3 or higher genitourinary or gastrointestinal toxicity cumulatively.
Time frame: First year of treatment
Quality of life before and after radiotherapy
To evaluate for multiple domains of quality of life before and after radiotherapy by using validated surveys including EPIC-26 in urinary continence, urinary obstruction, bowel, and sexual domains. Investigators will determine minimally important differences for each domain.
Time frame: First year of treatment
Efficacy of proton radiotherapy
To determine treatment efficacy of proton radiotherapy for all enrolled patients as evidenced by biochemical control in the months following radiation. Investigators will follow PSA to determine if there is evidence for biochemical recurrence following radiotherapy. PSA recurrence will be defined as an increase of 2 ng/ml higher than the nadir value following completion of radiotherapy.
Time frame: First year of treatment
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