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Focal Radiation Therapy (HDR-Brachytherapy) for Prostate Cancer

This study is looking at a type of radiation therapy called High-Dose Rate Brachytherapy (HDR-BT) for men with prostate cancer. HDR-BT is a treatment where radioactive material is placed directly into or near the tumor to kill cancer cells. The goal is to see if HDR-BT can effectively control the cancer while causing fewer side effects like problems with urinary or sexual function, which can sometimes happen with other prostate cancer treatments. You might be able to join if you are a man aged 40 or older with prostate adenocarcinoma (a type of prostate cancer) that has not spread. The study will measure side effects like genitourinary (urinary and reproductive organs) and gastrointestinal (digestive system) issues for up to 6 years to see how well this treatment works.

Study design
This is an interventional study planning to enroll 45 participants. It is a single-arm study, meaning all participants will receive the same treatment.
What's involved
You would undergo HDR-BT treatment, blood sample collections, and multiparametric magnetic resonance imaging (mpMRI). You may also have PSMA PET scans and tumor biopsies as needed.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for up to 6 years to monitor for side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07468903

Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate Cancer

Recruiting
NAAges 40+InterventionalTreatment
Jonsson Comprehensive Cancer Center
~45 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionHigh-Dose Rate BrachytherapyMultiparametric Magnetic Resonance ImagingPSMA PET ScanQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of grade 2 or greater genitourinary adverse events (AEs)
Measured over Up to 6 years
+3 more outcomes measured

Conditions

Prostate Adenocarcinoma
Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8
Stage II Prostate Cancer AJCC v8

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Alan C Lee · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center

Who to contact

Alan C. Lee
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
PSMA PET
Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0/1 within 60 days prior to enrollment
Age ≥ 40

Exclusion

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)

What this trial measures

  • Incidence of grade 2 or greater genitourinary adverse events (AEs)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 AEsUp 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 eventUp to 6 years

    Will be analyzed as a time-to-event outcome using Kaplan-Meier (KM) methods.

  • Local control rateUp 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.