Recruiting

SBRT

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT07276438

Conditions

Localized Prostate Adenocarcinoma

Stage I Prostate Cancer AJCC v8

Stage II Prostate Cancer AJCC v8

Stage III Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Computed Tomography

CT-guided Stereotactic Body Radiation Therapy

Inter-fraction Adaptation of Treatment Plan

Magnetic Resonance Imaging

Study Details

Brief summary:

This clinical trial studies the side effects of image-guidance and online adaptation with stereotactic body radiation therapy (SBRT) for the treatment of patients with prostate adenocarcinoma that has not spread to other parts of the body (localized). Image-guided SBRT is a standard treatment for localized prostate cancer. This treatment uses imaging of the cancer within the body to define and localize the area to be treated with the radiation. Imaging can be obtained using either computed tomography (CT), magnetic resonance imaging (MRI), or a combination of the two. Typically, with SBRT, a radiation plan is developed based on the CT or MRI images obtained before treatment begins and adjustments are not made to the plan during treatment. However, anatomy can be different from day-to-day which may cause radiation to be delivered to the normal surrounding structures and possibly more side effects. During image-guided SBRT with online adaptation, the initial radiation plan is designed similarly; however, when the patient presents for radiation, the attending radiation oncologist, a dosimetrist, and a medical physicist "re-optimize" the radiation plan using the current anatomy of the day, meaning the changes in bladder and prostate size/shape are taken into account. The initial plan and the re-optimized plan are then compared, and the plan that has the optimal balance between delivering a tumor killing dose of radiation and minimizing radiation dose to normal surrounding structures is delivered. Image-guidance and online adaptation with SBRT may lower side effects and be a safer way to treat localized prostate adenocarcinoma.

Conditions

Localized Prostate Adenocarcinoma

Stage I Prostate Cancer AJCC v8

Stage II Prostate Cancer AJCC v8

Stage III Prostate Cancer AJCC v8

Study ID

NCT07276438

Start date

Dec 1, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2032

Anticipated

Primary completion date

Dec 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18
  • Histologically confirmed, clinically localized adenocarcinoma of the prostate
  • Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping

  • Advanced imaging studies (i.e. prostate-specific membrane antigen \[PSMA\] positron emission tomography \[PET\]/CT and fluciclovine PET/CT scan) can supplant a bone scan if performed first
  • No evidence of metastatic disease in lymph nodes above the bifurcation of the renal arteries, or in bones or visceral organs (nodal disease identified on a PSMA PET/CT scan below the bifurcation of the renal arteries are amenable)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • No indication for urgent or emergent radiation
  • Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study

Exclusion Criteria:

  • Patients with neuroendocrine or small cell carcinoma of the prostate
  • Patients with any evidence of distant metastases except that evidence of lymphadenopathy below the level of the renal arteries can be deemed locoregional per the discretion of the investigator
  • Prior cryosurgery, high-intensity focused ultrasound (HIFU), brachytherapy, or other ablative treatments of the whole prostate
  • Prior pelvic radiotherapy
  • History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data

Study Design

Enrollment

186 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm 1 (non-adaptive SBRT)

Patients undergo MRI or CT-guided SBRT without daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.

experimental: Arm 2 (adaptive SBRT)

Patients undergo MRI or CT-guided SBRT with daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.

Interventions

Biospecimen Collection

Undergo blood sample collection

Computed Tomography

Undergo CT

CT-guided Stereotactic Body Radiation Therapy

Undergo CT-guided SBRT

Inter-fraction Adaptation of Treatment Plan

Undergo daily plan adaptation

Magnetic Resonance Imaging

Undergo MRI

MRI-guided Stereotactic Body Radiation Therapy

Undergo MRI-guided SBRT

Survey Administration

Ancillary studies

Primary outcome measure

  • Acute clinically relevant decline in the urinary irritative/obstructive subdomain of the Expanded Prostate Cancer Index Composite Short Form Questionnaire (EPIC-26) [ Time Frame: From start of stereotactic body radiation therapy (SBRT) to 90 days following SBRT ]

Central Contacts and Locations

Central contacts

Carol W. Felix

310-825-9771cfelix@mednet.ucla.edu

Christy Palodichuck

+1 310-794-2971cpalodichuk@mednet.ucla.edu

Locations

UCLA / Jonsson Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Care Felix

310-825-9771cfelix@mednet.ucla.edu

CHRISTY PALODICHUK

+1 310-794-2971cpalodichuk@mednet.ucla.edu

Principal Investigator:

Amar W. Kishan, MD

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-02-05.