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

NCT07468903 | Recruiting DMC FDA Device

• 2 other identifiers: 25-2298NCI-2026-01071
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Incidence of grade 2 or greater genitourinary adverse events (AEs)

  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.

  Up to 6 years

• Incidence of grade 2 or greater gastrointestinal AEs

  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.

  Up to 6 years

• Time to first grade 2 or greater adverse event

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

  Up to 6 years

• Local control rate

  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.

  Up to 6 years

Secondary Outcomes (7)

• Prostate specific antigen (PSA) response

  At 3, 6, 12 and 24 months

• Biochemical progression free survival

  Up to 5 years

• Clinical progression free survival

  Up to 5 years

• Distant metastasis free survival

  Up to 5 years

• Overall survival

  Up to 6 years

Study Arms (1)

Treatment (HDR-BT)

EXPERIMENTAL

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.

Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Radiation: High-Dose Rate Brachytherapy; Procedure: Multiparametric Magnetic Resonance Imaging; Procedure: PSMA PET Scan; Other: Questionnaire Administration

Interventions

Biopsy Procedure PROCEDURE

Undergo tumor biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Treatment (HDR-BT)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (HDR-BT)

High-Dose Rate Brachytherapy RADIATION

Undergo HDR-BT

Also known as: Brachytherapy, High Dose, HDR, High dose brachytherapy (procedure)

Treatment (HDR-BT)

Multiparametric Magnetic Resonance Imaging PROCEDURE

Undergo mpMRI

Also known as: MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI

Treatment (HDR-BT)

PSMA PET Scan PROCEDURE

Undergo PSMA PET

Also known as: Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography

Treatment (HDR-BT)

Questionnaire Administration OTHER

Ancillary studies

Treatment (HDR-BT)

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Biopsy; Specimen Handling; Brachytherapy; Glutamate Carboxypeptidase II

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Radiotherapy; Therapeutics; Carboxypeptidases; Exopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloexopeptidases; Metalloproteases

Study Officials

• Alan C Lee

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): May 11, 2031
• Study Completion (Estimated): May 11, 2032
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)