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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor: Medical University of South Carolina
Study ID: NCT07325721
Phase: PHASE2
Status: Recruiting

Apply to this trial

Conditions

Prostate Cancer
Prostate Cancer Patients Treated by Radiotherapy

Eligibility Criteria

Sex: MALE
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Hypofractionated radiation with a microboost — RADIATION
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.

Study Details

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.