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High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Prostate Cancer

This study is looking at how well two types of radiation therapy, High Dose-Rate Brachytherapy (HDR-BT) and Stereotactic Body Radiation Therapy (SBRT), work together to treat prostate adenocarcinoma (prostate cancer). HDR-BT uses radioactive material placed directly into or near the tumor, while SBRT uses precise radiation delivery to kill tumor cells with fewer treatments. The study aims to see if this combination can stop the cancer from returning for up to 5 years and to track any side effects like urinary or bowel problems within 90 days. You may be able to join if you are an adult male (18 years or older) with intermediate- to high-risk prostate adenocarcinoma and meet other health criteria. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 52 participants. It is investigating two radiation therapies for prostate cancer.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for biochemical failure for up to 5 years, and for patient-reported symptoms at 90 days.

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

NCT04945642

High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma

Recruiting
NAAges 18+InterventionalTreatment
Jonsson Comprehensive Cancer Center
~52 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:High-Dose Rate BrachytherapyStereotactic Body Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biochemical failure
Measured over Up to 5 years
+1 more outcome measured

Conditions

Prostate Adenocarcinoma
Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8
Stage IIC Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IIIA Prostate Cancer AJCC v8
Stage IIIB Prostate Cancer AJCC v8
Stage IIIC Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Stephanie M Yoon, MD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles

Who to contact

Vince Basehart
[email protected]
310-267-8954
Email the study team

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Eligibility criteria

Inclusion

Ability to understand a written informed consent document, and the willingness to sign it
Age \>= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA \> 10, and/or Gleason score \>= 7
No evidence of disease beyond the prostate and/or seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis)
Prostate size =\< 60cc
International Prognostic Scoring System (IPSS) score =\< 15
Able to safely receive moderate sedation or general anesthesia

Exclusion

Patients with neuroendocrine or small cell carcinoma of the prostate
Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years
Regional lymph node involvement
Evidence of distant metastases
Previous radical surgery (prostatectomy) or cryosurgery or high-intensity focused ultrasound for prostate cancer
Previous pelvic irradiation or prostate brachytherapy
Previous or concurrent cytotoxic chemotherapy for prostate cancer
Patients with history of inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), high predisposition for radio-toxicity compared to general population (i.e., ataxia telangiectasia), or at risk for major bowel surgery
Transurethral resection of the prostate (TURP) procedure within 6 months of radiation treatment

What this trial measures

  • Biochemical failureUp to 5 years

    Will be based on Phoenix criteria (either a rise of 2 ng/mL or more above nadir prostate specific antigen \[PSA\], or patients not meeting this criterion but underwent salvage therapies). The biochemical progression free survival (b-PFS) will be defined from the date of completing radiotherapy to the date biochemical failure, death, or last follow-up, stratified by prostate cancer risk classification. Kaplan-Meier method will be used.

  • Patient-reported genitourinary (GU) and gastrointestinal (GI) symptomsAt 90 days

    Will be assessed on the Expanded Prostate Cancer Index-26 (EPIC-26) questionnaire.