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NCT Number: NCT07468903

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

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.

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Key information

Conditions

Prostate Adenocarcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8 Stage II Prostate Cancer AJCC v8 Urogenital Diseases Urogenital Neoplasms

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location status: Recruiting

Location contact

Alan C. Lee

CONTACT

[email protected]

Alan C. Lee

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVES:

I. Estimate local control. II. Estimate acute/late grade 2+ genitourinary (GU)/gastrointestinal (GI) toxicity.

SECONDARY OBJECTIVES:

I. Prostate specific antigen (PSA) response at 6 weeks after radiation therapy (RT), every 3 months for 24 months, every 6 months to 60 months, then every 8-12 months until 5 years.

II. Clinical progression free survival/biochemical progression free survival at 5 years.

III. Distant metastasis free survival. IV. Development of castration-resistant disease. V. Overall survival. VI. Changes in quality of life VIa. Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire; VIb. Expanded Prostate Cancer Index Composite Short Form (EPIC-26) questionnaire.

OUTLINE:

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, multiparametric (mp) magnetic resonance imaging (MRI) and optionally prostate-specific membrane antigen (PSMA) positron emission tomography (PET) throughout the study. Additionally, patients may undergo tumor biopsy as clinically indicated throughout the study.

After completion of study treatment, patients are followed up at 6 weeks, every 3 months for the first 2 years, every 6 months for years 3 and 4, then annually thereafter.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Biopsy Procedure

Procedure

Undergo tumor biopsy

Other names: Biopsy, BIOPSY_TYPE, Bx

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

High-Dose Rate Brachytherapy

Radiation

Undergo HDR-BT

Other names: Brachytherapy, High Dose, HDR, High dose brachytherapy (procedure)

Multiparametric Magnetic Resonance Imaging

Procedure

Undergo mpMRI

Other names: MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI

PSMA PET Scan

Procedure

Undergo PSMA PET

Other names: Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Prostate specific antigen (PSA) response

    Time frame: At 3, 6, 12 and 24 months

    PSA changes over time will be assessed via repeated measures analysis of variance (ANOVA). If significant PSA changes over time are identified by repeated measures ANOVA, the individual comparisons between time points will be evaluated via Tukey's Honestly Significant Difference test as the method of accommodating multiple comparisons.

  2. Biochemical progression free survival

    Time frame: Up to 5 years

    Will be obtained via KM analysis to provide an overview of efficacy for focal RT.

  3. Clinical progression free survival

    Time frame: Up to 5 years

    Will be obtained via KM analysis to provide an overview of efficacy for focal RT.

  4. Distant metastasis free survival

    Time frame: Up to 5 years

    Will be obtained via KM analysis to provide an overview of efficacy for focal RT.

  5. Overall survival

    Time frame: Up to 6 years

    Will be obtained via KM analysis to provide an overview of efficacy for focal RT.

  6. Patient reported quality of life

    Time frame: Up to 6 years

    Will be evaluated using Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P). The FACT-P uses a 5-point Likert scale for scoring, with total scores ranging from 0 to 156. Higher scores indicate better quality of life. The change of the scores between the time of pre-focal RT and post-focal RT will be assessed via two-sided paired t-test.

  7. Expanded Prostate Cancer Index Composite Short Form questionnaire score

    Time frame: Up to 6 years

    The change of the scores between the time of pre-focal RT and post-focal RT will be assessed via two-sided paired t-test.

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Registry information

Official study title

Phase II Trial of Focal Radiation Therapy in Patients With Prostate Cancer

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Mar 13, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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