Prostate AdenocarcinomaNCT07468903
Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate Cancer
A study testing Biopsy Procedure, Biospecimen Collection and High-Dose Rate Brachytherapy in people with Prostate Adenocarcinoma and Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage II Prostate Cancer AJCC v8
- What is being tested?
- Biopsy Procedure, Biospecimen Collection and High-Dose Rate Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2026to 11 May 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Alan C. Lee, alalee@mednet.ucla.edu
Alan C. Lee
About this study
Official title: Phase II Trial of Focal Radiation Therapy in Patients With 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.
Read the detailed description
PRIMARY OBJECTIVES:
- Estimate local control. II. Estimate acute/late grade 2+ genitourinary (GU)/gastrointestinal (GI) toxicity.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Prostate Adenocarcinoma, Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage II Prostate Cancer AJCC v8
- Being tested
- Biopsy Procedure, Biospecimen Collection, High-Dose Rate Brachytherapy, Multiparametric Magnetic Resonance Imaging, PSMA PET Scan
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo tumor biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
High-Dose Rate BrachytherapyRadiation
Also called Brachytherapy, High Dose, HDR, High dose brachytherapy (procedure)
Undergo HDR-BT
Multiparametric Magnetic Resonance ImagingProcedure or surgery
Also called MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI
Undergo mpMRI
PSMA PET ScanProcedure or surgery
Also called Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography
Undergo PSMA PET
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Radiation: High-Dose Rate Brachytherapy; Procedure: Multiparametric Magnetic Resonance Imaging; Procedure: PSMA PET Scan; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 years
Secondary outcomes (7)
Prostate specific antigen (PSA) response
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.
Measured: At 3, 6, 12 and 24 months
Biochemical progression free survival
Will be obtained via KM analysis to provide an overview of efficacy for focal RT.
Measured: Up to 5 years
Clinical progression free survival
Will be obtained via KM analysis to provide an overview of efficacy for focal RT.
Measured: Up to 5 years
Distant metastasis free survival
Will be obtained via KM analysis to provide an overview of efficacy for focal RT.
Measured: Up to 5 years
Overall survival
Will be obtained via KM analysis to provide an overview of efficacy for focal RT.
Measured: Up to 6 years
Patient reported quality of life
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.
Measured: Up to 6 years
Expanded Prostate Cancer Index Composite Short Form questionnaire score
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.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start11 May 2026
- Primary completion11 May 2031 (estimated)
- Study completion11 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan C Lee, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468903
- Sponsor's protocol ID
- 25-2298
- Other IDs
- NCI-2026-01071
- Status last verified
- May 2026
- First submitted
- 9 Mar 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Focal Radiation Therapy in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT07468903
- Acronym / sponsor ID
- 25-2298
- Conditions
- Prostate Adenocarcinoma, Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage II Prostate Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- 11 May 2031 (estimated)
- Study completion
- 11 May 2032 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Estimate local control. II. Estimate acute/late grade 2+ genitourinary (GU)/gastrointestinal (GI) toxicity.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (HDR-BT) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Radiation: High-Dose Rate Brachytherapy, Procedure: Multiparametric Magnetic Resonance Imaging, Procedure: PSMA PET Scan, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0/1 within 60 days prior to enrollment
- Age ≥ 40
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy ProcedureAlso: Biopsy, BIOPSY_TYPE, BxUndergo tumor biopsy | Procedure or surgery | Treatment (HDR-BT) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (HDR-BT) |
| High-Dose Rate BrachytherapyAlso: Brachytherapy, High Dose, HDR, High dose brachytherapy (procedure)Undergo HDR-BT | Radiation | Treatment (HDR-BT) |
| Multiparametric Magnetic Resonance ImagingAlso: MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRIUndergo mpMRI | Procedure or surgery | Treatment (HDR-BT) |
| PSMA PET ScanAlso: Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomographyUndergo PSMA PET | Procedure or surgery | Treatment (HDR-BT) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (HDR-BT) |
Primary outcome
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.
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.
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.
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alan C Lee principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy Procedure, Biospecimen Collection and High-Dose Rate Brachytherapy in people with Prostate Adenocarcinoma and Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade 2 or greater genitourinary adverse events (AEs) (time frame: Up to 6 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.