Elective Pelvic Ultra Hypofractionated Irradiation Treatment with High Dose Rate Brachytherapy Boost for the Treatment of Unfavorable and Higher Risk Prostate Cancer

PRIMARY OBJECTIVE:

I. Physician-reported acute grade ≥ 2 genitourinary (GU) toxicity following elective pelvic ultra-hypofractionated radiation treatment (ePUHRT) with high dose rate (HDR) boost.

SECONDARY OBJECTIVES:

I. Physician-reported acute grade ≥ 2 gastrointestinal (GI) toxicity following ePUHRT with HDR boost.

II. Patient-reported acute grade ≥ 2 GI and GU toxicity following ePUHRT with HDR boost.

EXPLORATORY OBJECTIVES:

I. Biochemical recurrence-free survival.

II. Disease-free survival.

III. Metastasis-free survival.

IV. Prostate cancer specific survival.

V. Overall survival.

VI. To explore disease control outcomes post ePUHRT with HDR boost.

VII. To explore the impact of treatment on patients’ quality-of-life.

OUTLINE:

Patients undergo transperineal catheter placement using real-time transrectal ultrasound guidance and receive 1 treatment of HRD brachytherapy radiation. After 2-6 weeks, patients undergo hypofractionated radiation once per day on alternate days (2-3 treatments per week) for 5 treatments in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy per standard of care, as determine by their treating physician. Patients undergo bone scan or prostate specific membrane antigen positron emission tomography (PSMA PET) scan, computed tomography (CT) scan or magnetic resonance imaging (MRI) and blood sample collection during screening and may undergo blood sample collection during follow up.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for an additional year, and then at the discretion of the treating physician, up to 5 years.