RecruitingInterventional

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

NCT ID: NCT07468903Sponsor: Jonsson Comprehensive Cancer CenterLast updated: 2026-05-22

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.

Detailed description

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.

Arms & interventions

ProcedureBiopsy Procedure
Undergo tumor biopsy
ProcedureBiospecimen Collection
Undergo blood sample collection
RadiationHigh-Dose Rate Brachytherapy
Undergo HDR-BT
ProcedureMultiparametric Magnetic Resonance Imaging
Undergo mpMRI
ProcedurePSMA PET Scan
Undergo PSMA PET
OtherQuestionnaire Administration
Ancillary studies

Outcome measures

Primary

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 years

Secondary

Prostate specific antigen (PSA) response
Time frame: At 3, 6, 12 and 24 months
Biochemical progression free survival
Time frame: Up to 5 years
Clinical progression free survival
Time frame: Up to 5 years
Distant metastasis free survival
Time frame: Up to 5 years
Overall survival
Time frame: Up to 6 years
Patient reported quality of life
Time frame: Up to 6 years
Expanded Prostate Cancer Index Composite Short Form questionnaire score
Time frame: Up to 6 years

Eligibility criteria

Sex: MaleAge: 40 Years and olderHealthy volunteers: No

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 locations (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095

Recruiting

Alan C. Lee · Contact

alalee@mednet.ucla.edu

Alan C. Lee · Principal Investigator