NCT04725903

Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer

Extended-Field Lymph Node Proton Irradiation for High Risk Prostate Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial investigates whether proton radiation therapy directed to the prostate tumor, pelvic, and para-aortic lymph nodes, is an effective way to treat patients with high-risk or lymph node positive prostate cancer who are receiving radiation therapy, and if it will result in fewer gastrointestinal and genitourinary side effects. Proton beam therapy is a new type of radiotherapy that directs multiple beams of protons (positively charged subatomic particles) at the tumor target, where they deposit the bulk of their energy with essentially no residual radiation beyond the tumor. By reducing the exposure of the healthy tissues and organs to radiation in the treatment of prostate cancer, proton therapy has the potential to better spare healthy tissue and reduce the side effects of radiation therapy.

Detailed description

PRIMARY OBJECTIVE: I. To determine the rate of acute grade 2+ gastrointestinal toxicity compared to historical photon treatments. SECONDARY OBJECTIVES: I. To determine the rate of acute grade 2+ genitourinary toxicity compared to historical photon treatments. II. To assess the feasibility of extended-field proton irradiation of high-risk prostate. III. To demonstrate safety of proton therapy followed by high dose rate (HDR) boost. IV. To determine patient-reported outcomes (PROs) of toxicity. OUTLINE: Patients undergo conventionally fractionated proton beam therapy daily on Monday-Friday. Patients may receive a high-dose rate brachytherapy boost. After completion of study treatment, patients are followed up at 1, 3, 6, 9 and 12 months, and 1.5, 2, 2.5, and 3 years.

Conditions

• Stage III Prostate Cancer AJCC v8
• Stage IIIA Prostate Cancer AJCC v8
• Stage IIIB Prostate Cancer AJCC v8
• Stage IIIC Prostate Cancer AJCC v8

Interventions

Type	Name	Description
RADIATION	High-Dose Rate Brachytherapy	Receive high-dose rate brachytherapy boost
RADIATION	Proton Beam Radiation Therapy	Undergo proton beam therapy
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2021-02-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2021-01-27
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study