NCT07325721

Hypofractionated Radiotherapy With a Focal Microboost for High-Risk and Locally Advanced Prostate Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is for adult men with previously untreated high risk, very high risk, or pelvic lymph node positive prostate cancer. The purpose of this study is to evaluate the safety and effectiveness of the combination of two emerging radiation treatment techniques (hypofractionated radiotherapy and microboost technique). Participation will include standard of care visits along with questionnaires and blood draws completed for research purposes. There is optional banking of blood and prostate biopsy tissue which will not require extra biopsies. Participation in this study is anticipated to last approximately 6 weeks with follow up every three months for two years then twice yearly for years 3-5.

Conditions

• Prostate Cancer
• Prostate Cancer Patients Treated by Radiotherapy

Interventions

Type	Name	Description
RADIATION	Hypofractionated radiation with a microboost	Patients will receive 25 fractions of external beam radiation therapy. Dose to the elective lymph nodes will be 45 Gy in 25 fractions. Dose to the prostate and portions of the seminal vesicles will be 68 Gy in 25 fractions. A microboost to up to three dominant intraprostatic nodules will be given in 25 fractions (dose range 70-83 Gy). Simultaneous integrated boost to sites of pelvic lymphadenopathy may be given. Androgen deprivation therapy will be per local standard of care.

Timeline

• Start date: 2026-02-02
• Primary completion: 2029-01-01
• Completion: 2034-01-01
• First posted: 2026-01-08
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study