TRUEBEAM Stereotactic Body Radiotherapy for Localized Prostate Cancer

NCT04552509 | Recruiting DMC FDA Device

• 1 other identifier: 790-17
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of TrueBeam stereotactic body radiosurgery in patients with prostate cancer. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. The purpose of this evaluation is to see if this treatment will help patients with your condition and to evaluate the effect of this treatment on your quality of life over time. Radiosurgery is a non-invasive treatment technique used to treat tumors. Despite the word "surgery" in the name, the technology does not remove the tumor with a surgical knife. Instead, a focused, high-intensity beam of radiation targets the tumor, while minimizing dose to surrounding normal healthy tissue.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Local control

  Rate of disease recurrence locally

  5 years

Study Arms (1)

Observation

OTHER

Observational study of patient efficacy and side effects

Radiation: Stereotactic Body Radiotherapy

Interventions

Stereotactic Body Radiotherapy RADIATION

Treatment of prostate cancer with stereotactic body radiation therapy (SBRT)

Observation

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.
• ECOG performance status 0-1
• Completion of patient questionnaires in section 4.7.
• Consent signed

You may not qualify if:

• Prior prostatectomy or cryotherapy of the prostate
• Prior radiotherapy to the prostate or lower pelvis
• Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.

Sponsors & Collaborators

• Linda Chan, MD: lead

Study Sites (1)

MemorialCare Saddleback Medical Center

Laguna Hills, California, 92653, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Linda Chan, MD

  Memorial Health Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Chan, MD

CONTACT

562-933-0300; lchan@memorialcare.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 17, 2020
• Study Start: June 5, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)