NCT07325721 Hypofractionated Radiotherapy With a Focal Microboost for High-Risk and Locally Advanced Prostate Cancer
| NCT ID | NCT07325721 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Medical University of South Carolina |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2029-01-01 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Biologically male patients aged 18 years and older. 4. Ability to receive pelvic radiotherapy and be willing to adhere to the protocol regimen. 5. Previously untreated prostate cancer (with cytotoxic chemotherapy, cryotherapy, ablative treatment, surgical or radiation therapy). Prior transurethral resection of prostate (TURP) is permitted if 90 days or more prior to the start of radiotherapy. 6. Localized or locally advanced prostate cancer meeting NCCN criteria for high risk, very high risk or non-metastatic, pelvic lymph node positive defined as having at least one or more of the following: 1. PSA \>20 ng/mL prior to starting ADT. 2. cT3a-T4 by digital exam or imaging. 3. Gleason score of 8-10 (grade group 4 or 5). 4. Staged as N1M0 by the treating investigator (pelvic lymph node positive, below the ao
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