NCT07468903 · Jonsson Comprehensive Cancer Center
Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate Cancer
What this study is about
This clinical trial tests the effect of focal radiation therapy, high dose rate-brachytherapy (HDR-BT), in treating patients with prostate cancer. Prostate cancer is the most diagnosed cancer in men and there are many treatments available, including surgery and radiation therapy.
View original scientific description
This clinical trial tests the effect of focal radiation therapy, high dose rate-brachytherapy (HDR-BT), in treating patients with prostate cancer. Prostate cancer is the most diagnosed cancer in men and there are many treatments available, including surgery and radiation therapy. Although surgery and radiation therapy improve survival urinary and sexual function can be significantly affected and can be long lasting. HDR-BT, a type of focal radiation therapy also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving HDR-BT may be effective in providing local control while reducing side effects in patients with prostate cancer.
Interventions
PROCEDURE
Biopsy Procedure
Undergo tumor biopsy
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
RADIATION
High-Dose Rate Brachytherapy
Undergo HDR-BT
PROCEDURE
Multiparametric Magnetic Resonance Imaging
Undergo mpMRI
PROCEDURE
PSMA PET Scan
Undergo PSMA PET
OTHER
Questionnaire Administration
Ancillary studies
Primary outcome measures
Incidence of grade 2 or greater genitourinary adverse events (AEs)
Time frame: Up to 6 years
Will be defined as the percentage of patients who encounter the AE of specific grade or worse using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be calculated to indicate the toxicity level of focal radiation therapy (RT), along with the corresponding 95% Clopper-Pearson exact confidence interval.
Incidence of grade 2 or greater gastrointestinal AEs
Time frame: Up to 6 years
Will be defined as the percentage of patients who encounter the AE of specific grade or worse using CTCAE v 5.0. Will be calculated to indicate the toxicity level of focal RT, along with the corresponding 95% Clopper-Pearson exact confidence interval.
Time to first grade 2 or greater adverse event
Time frame: Up to 6 years
Will be analyzed as a time-to-event outcome using Kaplan-Meier (KM) methods.
Local control rate
Time frame: Up to 6 years
Will be defined as lack of biopsy proven progression within target/treated region/lesion. The proportion of patients achieving local control will be estimated along with the corresponding 95% Clopper-Pearson exact confidence interval.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologically confirmed diagnosis of prostate adenocarcinoma within 90 days prior to registration via systematic biopsy
- Multiparametric MRI (mp-MRI) confirmed lesion(s)
- No distant or locally advanced disease on standard staging exams as indicated
- Bone scan and abdominopelvic computed tomography (CT)/MRI OR
- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0/1 within 60 days prior to enrollment
Exclusion criteria
- Radiographic nodal or distant metastatic disease
- Lesion(s) comprising \> 40% of total prostate volume
- Prior radiotherapy to the pelvis
- Gleason score \> 6 disease outside intended gross target volume (GTV)/target region(s)
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations