Actively Recruiting
Hypofractionated Radiotherapy With a Focal Microboost for High-Risk and Locally Advanced Prostate Cancer
Led by Medical University of South Carolina · Updated on 2026-02-05
46
Participants Needed
1
Research Sites
412 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Hypofractionated Radiotherapy With a Focal Microboost for High-Risk and Locally Advanced Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent provided.
- Willing to follow all study procedures and available for the study duration.
- Biologically male patients aged 18 years or older.
- Able to receive pelvic radiotherapy and willing to follow the study regimen.
- Previously untreated prostate cancer; prior transurethral resection of prostate allowed if done 90+ days before radiation.
- Localized or locally advanced prostate cancer meeting high risk, very high risk, or non-metastatic pelvic lymph node positive criteria.
- History and physical exam within 120 days before registration.
- ECOG performance status of 0 to 2.
- Able to undergo MRI of prostate and/or pelvis for radiation planning.
- Have at least one MRI-visible target for microboost (PI-RADS 4 or higher).
- Bone and soft tissue imaging as needed for staging within 120 days before registration.
- Use effective contraception during radiation and for six months after.
- Adequate blood and liver function within 120 days before registration.
- Agreeable and eligible to receive long-term androgen deprivation therapy (12-36 months).
You will not qualify if you...
- Concurrent use of testosterone supplements unless stopped by registration.
- Evidence of metastatic disease outside pelvic lymph nodes on imaging.
- Prior pelvic radiation therapy.
- Health status or conditions that prevent curative radiation therapy; life expectancy less than 5 years.
- Treatment with other investigational prostate cancer therapy within 12 months.
- Prior prostate surgeries or ablative treatments like prostatectomy, cryotherapy, HIFU, etc.
- Prior or current invasive pelvic or hematologic malignancies unless disease-free for 5 years.
- Conditions that would prevent study participation as judged by investigator.
- Prior pharmacologic androgen ablation started more than 90 days before registration.
- Unable to have gold fiducial markers or rectal spacer gel implanted.
- Prior or concurrent malignancy that could interfere with safety or efficacy assessments.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
H
Harriet Eldredge-Hindy Eldredge-Hindy, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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