RecruitingPhase 2NCT07325721

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


Sponsor

Medical University of South Carolina

Enrollment

46 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a focused form of radiation therapy for men with high-risk or locally advanced prostate cancer. The treatment delivers a concentrated "microboost" of radiation to the most active area of the tumor, aiming to kill cancer more effectively while minimizing damage to surrounding tissue. **You may be eligible if...** - You are a male aged 18 or older - You have high-risk or very high-risk prostate cancer that has not yet spread to distant sites - Your cancer has not been previously treated with radiation, surgery, or similar therapies - You have at least one visible tumor area on MRI that can be targeted - You are able to receive long-term hormone therapy (12–36 months) as part of standard care - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread beyond the pelvis - You have had previous pelvic radiation - You have had a full prostatectomy or other definitive prostate procedures - You are currently taking testosterone supplements - You have a life expectancy of less than 5 years - You have another active cancer (with exceptions for cancers cleared for 5+ years) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHypofractionated 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.


Locations(1)

Medical University of South Carolina Hollings Cancer Center

Charleston, South Carolina, United States

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NCT07325721


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