Observational Study of Stereotactic Body Radiotherapy for Prostate Cancer

This study is looking at men who have already had surgery for prostate cancer and are now receiving a type of radiation called stereotactic body radiotherapy (SBRT). This radiation uses advanced imaging (MRI or CT scans) to precisely target the prostate area, sometimes including nearby lymph nodes. The goal is to see how this treatment affects your urinary and digestive quality of life over 24 months. Doctors will decide if an "adaptive" treatment, which adjusts the radiation during treatment, is right for you. We are aiming to enroll 200 participants for the adaptive treatment group. The main goal is to measure your genitourinary (urinary and reproductive organs) health after 5 years.

Study design
This is an observational study, meaning researchers will watch and collect information about your treatment and health. It is a single-arm study, so everyone receives the same type of treatment. The study plans to enroll 200 participants for the adaptive treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your genitourinary health will be measured for 5 years after treatment.

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NCT07077239

Prostate Cancer Postoperative Stereotactic Body Radiotherapy With Adaptive Technology for Minimizing Toxicity

Recruiting
Not specifiedAges 18+Observational
Jonsson Comprehensive Cancer Center
~200 participants
Updated 2026-08-20 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Genitourinary Domain Score
Measured over 5 years
Prostate Cancer (CRPC)
1 sites across 1 states
California1
  • Luca Valle, MD · PRINCIPAL_INVESTIGATOR · University of California at Los Angeles

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent.
Presence of any ONE of the following:
CT scan and MRI of the pelvis within 120 days prior to enrollment \[note: (a) if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed; (b) for patients with PSA \<1.0 ng/mL, the treatment planning CT can substitute for a diagnostic CT scan; (c) a low-field, radiation planning MRI can replace the diagnostic MRI if the patient refuses or cannot obtain a high-field MRI\].
Bone scan OR advanced nuclear imaging study within 120 days prior to enrollment for patients with PSA \>1.0 ng/mL.
Age ≥ 18.
Ability to understand, and willingness to sign, the written informed consent

Exclusion

Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator.
Patients with neuroendocrine or small cell carcinoma of the prostate
Prior pelvic radiotherapy
History of Crohn's Disease, Ulcerative Colitis, or Ataxia Telangiectasia
  • Genitourinary Domain Score5 years

    To determine the rate of 2x MCID changes in any genitourinary domain score of the patient-reported EPIC-26 QOL tool at any point between the start of treatment and 24-months following CT-guided or MRI-guided adaptive stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes.