Recruiting

HDR-BT

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT07468903

Conditions

Prostate Adenocarcinoma

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

Stage II Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Biopsy Procedure

Biospecimen Collection

High-Dose Rate Brachytherapy

Multiparametric Magnetic Resonance Imaging

PSMA PET Scan

Study Details

Brief summary:

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.

Conditions

Prostate Adenocarcinoma

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

Stage II Prostate Cancer AJCC v8

Study ID

NCT07468903

Start date

May 11, 2026

Status verified date

May, 2026

Completion date

May 11, 2032

Anticipated

Primary completion date

May 11, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

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

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)

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (HDR-BT)

Patients undergo HDR-BT to dominant prostate lesion on day 1. Treatment repeats at least 3 weeks apart for up to 2 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, mpMRI and optionally PSMA PET throughout the study. Additionally, patients may undergo tumor biopsy as clinically indicated throughout the study.

Interventions

Biopsy Procedure

Undergo tumor biopsy

Biospecimen Collection

Undergo blood sample collection

High-Dose Rate Brachytherapy

Undergo HDR-BT

Multiparametric Magnetic Resonance Imaging

Undergo mpMRI

PSMA PET Scan

Undergo PSMA PET

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Incidence of grade 2 or greater genitourinary adverse events (AEs) [ Time Frame: Up to 6 years ]
  • Incidence of grade 2 or greater gastrointestinal AEs [ Time Frame: Up to 6 years ]
  • Time to first grade 2 or greater adverse event [ Time Frame: Up to 6 years ]
  • Local control rate [ Time Frame: Up to 6 years ]

Central Contacts and Locations

Locations

UCLA / Jonsson Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Alan C. Lee

alalee@mednet.ucla.edu

Principal Investigator:

Alan C. Lee

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-05-22.