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Can a High-Tech radiation beam hit prostate tumors without harming healthy tissue?

NCT ID NCT04552509

Disease control Sponsor: Linda Chan, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial tests whether stereotactic body radiotherapy (SBRT) using the TrueBeam system can effectively treat localized prostate cancer. The approach delivers high-dose radiation precisely to the tumor, aiming to minimize damage to surrounding healthy tissue. Researchers will track how well the treatment controls the cancer locally and how it affects patients' quality of life over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Stereotactic body radiotherapy (SBRT) using the TrueBeam system
What this could lead to
If successful, this approach could offer a more precise, non-invasive radiation option for prostate cancer, potentially reducing side effects and improving quality of life.
What could go wrong
This is an early-stage evaluation, and results may not confirm long-term effectiveness. Radiation can still cause side effects, and the trial's findings may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 167 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Histologically proven prostate adenocarcinoma * Biopsy within 12 months of date of registration required except for patients who already meet criteria for enrollment in the high risk arm of the protocol. For these patients, repeat biopsy will be at the discretion of the treating physician. In general, repeat biopsy is recommended for these patients, but is not required if it will not affect the treating physician's management decisions in regards to the care of the patient. 2. Clinical Stage I-IV, MX-M0 (AJCC 6th Edition) * M-stage determined by physical exam, CT, MRI, or Bone Scan. Bone scan not required for Monotherapy Risk Group patients unless clinical findings suggest possible osseous metastases. Bone Scan and contrast CT of the abdomen should be done patients in the Boost Risk Group patients. 3. Prostate volume: ≤ 100 cc (recommended not required) * Determined using: volume = π/6 x length x height x width * Measurement from CT or ultrasound ≤90 days prior to registration. 4. ECOG performance status 0-1 5. Completion of patient questionnaires in section 4.7. 6. Consent signed Exclusion Criteria: 1. Prior prostatectomy or cryotherapy of the prostate 2. Prior radiotherapy to the prostate or lower pelvis 3. Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • MemorialCare Saddleback Medical Center

    Laguna Hills, California, 92653, United States

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