This phase II trial studies how well dose-escalated proton radiation therapy with a simultaneous integrated boost (SIB) to magnetic resonance imaging (MRI)-identified tumors within the prostate (intraprostatic) works in treating patients with high-risk prostate cancer. Previous studies have shown an advantage for delivering higher (escalated) radiation doses for prostate cancer when looking at overall disease control outcomes. This trial features hypofractionation (radiation delivered with a higher daily dose) and an extra boost (SIB) of radiation to the prostate tumor seen on pretreatment imaging (MRI) as a method of delivering higher radiation doses for high-risk prostate cancers. Giving dose-escalated proton radiation therapy with SIB to MRI-identified intraprostatic tumors may be able to improve disease control for patients with high-risk prostate cancer while minimizing possible toxicity (side effects).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03624660.
PRIMARY OBJECTIVE:
I. To demonstrate that the addition of a simultaneous integrated boost to intraprostatic tumors (IPT) will improve 5 year biochemical control by 15% for patients with high-risk prostate cancer treated with proton therapy when compared to similar patients treated at University of Florida Proton Therapy Institute (UFPTI) from 2006 to 2010 who had a 55% biochemical control rate at 5 years.
SECONDARY OBJECTIVES:
I. To demonstrate an improvement in disease free survival with proton-based therapy in patients treated with the addition of a simultaneous integrated boost to IPT.
II. To evaluate morbidity outcomes including the rate of grade ≥ 3 gastrointestinal (GI) and genitourinary following treatment with proton-based therapy in patients treated with the addition of a simultaneous integrated boost to IPT.
III. To determine biologic, treatment and diagnostic related information that may impact quality of life, disease control, morbidity and/or survival outcomes with proton- based therapy in patients treated with the addition of a simultaneous integrated boost to IPT.
OUTLINE: Patients with a < 15% risk of positive pelvic lymph nodes and negative for seminal vesicle invasion are assigned to Group HR-A, while patients with ≥ 15% risk of positive pelvic lymph nodes or with seminal vesicle invasion are assigned to Group HR-B
GROUP HR-A: Patients undergo proton radiation therapy (RT) once daily (QD), 5 days a week, for up to a total of 39 treatment fractions (8-9 weeks) in the absence of disease progression or unacceptable toxicity. Patients undergo hypofractionated proton RT to the prostate and seminal vesicles, as well as SIB boost to MRI-identified IPT.
GROUP HR-B: Patients undergo proton RT QD, 5 days a week, for up to a total of 39 treatment fractions (8-9 weeks) in the absence of disease progression or unacceptable toxicity. Patients undergo hypofractionated proton RT to the prostate, seminal vesicles, and pelvic lymph nodes over 23 treatment fractions with an additional 16 treatment fractions to the prostate and seminal vesicles. Patients also undergo a SIB boost to MRI-identified IPT over 39 treatment fractions.
Patients in both groups also undergo trans-rectal ultrasound, MRI, chest X-ray, bone scan, bone X-ray, Axumin positron emission tomography/computed tomography (PET/CT) or prostate-specific membrane antigen (PSMA) PET/CT, and sodium fluoride PET bone scan during screening, as well as prostate planning/simulation CT and MRI scan during screening and on study, and may undergo prostate biopsy as clinically indicated.
After completion of study treatment, patients are followed up at 3 months and then annually up to 5 years.
Lead OrganizationUniversity of Florida Proton Therapy Institute
Principal InvestigatorCurtis M Bryant
