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Recruiting NCT07468903

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

No phase Interventional Prostate Adenocarcinoma Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8 Stage II Prostate Cancer AJCC v8

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biopsy Procedure, Biospecimen Collection, High-Dose Rate Brachytherapy, Multiparametric Magnetic Resonance Imaging.
Who it may be relevant to
Registry conditions: Prostate Adenocarcinoma, Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage II Prostate Cancer AJCC v8. Basic parameters: from 40 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Biopsy Procedure
    Undergo tumor biopsy
  • Procedure Biospecimen Collection
    Undergo blood sample collection
  • Radiation High-Dose Rate Brachytherapy
    Undergo HDR-BT
  • Procedure Multiparametric Magnetic Resonance Imaging
    Undergo mpMRI
  • Procedure PSMA PET Scan
    Undergo PSMA PET
  • Other Questionnaire Administration
    Ancillary studies

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • 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

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • UCLA / Jonsson Comprehensive Cancer Center — Los Angeles

Identifiers

NCT: NCT07468903 · 25-2298 · NCI-2026-01071

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗