NCT04190446

A Study to Evaluate Hypofractionated Proton Therapy or IMRT for Recurrent, Oligometastatic Prostate Cancer

A Randomized, Parallel Phase II Trial of Hypofractionated Proton Therapy or IMRT for Recurrent, Oligometastatic Prostate Cancer Involving Only Pelvic and/or Para-Aortic Lymph Nodes Following Primary Localized Treatment

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects of radiation therapy (hypofractionated proton beam therapy or IMRT) for the treatment of prostate cancer that has come back (recurrent) or that has spread to a limited number of sites (oligometastatic) following primary localized treatment. Hypofractionated proton beam radiation therapy delivers smaller doses of radiation therapy over time and may kill more tumor cells and have fewer side effects. IMRT uses high energy x-rays to kill tumor cells and shrink tumors. This trial is being done to find out if a shorter course of radiation therapy is better with fewer side effects for patients with recurrent prostate cancer.

Detailed description

PRIMARY OBJECTIVE: I. To assess late \>= grade 3 gastrointestinal (GI) and/or genitourinary (GU) toxicity of interest with the hypofractionated regimen with proton beam therapy or intensity-modulated radiation therapy (IMRT) (late defined as 3 to 24 months after protocol radiation therapy \[RT\]). SECONDARY OBJECTIVES: I. Late grade \>= 2 GI and/or GU toxicities of interest within 24 months after the protocol RT, using the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0. II. Acute grade \>= 3 GI and/or GU toxicities of interest during and within 3 months after the protocol RT, using the CTCAE v4.0. III. Compare the rates of late \>= grade 3 GI and/or GU toxicity between the 2 treatment schedules. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo proton beam radiation therapy 5 days a week over 3 weeks. Patients undergo positron emission tomography (PET) scan, computed tomography (CT) scan, magnetic resonance imaging (MRI), and blood sample collection throughout the study. ARM II: Patients undergo IMRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study. After completion of study, patients are followed up at 3-6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months.

Conditions

• Metastatic Prostate Adenocarcinoma
• Oligometastatic Prostate Carcinoma
• Prostate Adenocarcinoma
• Recurrent Prostate Carcinoma
• Stage IV Prostate Cancer AJCC v8

Interventions

Type	Name	Description
RADIATION	Intensity-Modulated Radiation Therapy	Undergo IMRT
RADIATION	Proton Beam Radiation Therapy	Undergo proton beam radiation therapy
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Computed Tomography	Undergo CT scan
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Biospecimen Collection	Undergo blood sample collection

Timeline

• Start date: 2020-01-06
• Primary completion: 2025-11-22
• Completion: 2028-11-22
• First posted: 2019-12-09
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study