TRUEBEAM Stereotactic Body Radiotherapy for Localized Prostate Cancer

Recruiting now · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT04552509

Run by

Linda Chan, MD

People needed

167

Starts

2018-06-05

Expected to finish

2026-12-01

Last updated by the study team

2025-07-22

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

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.

Where it is running

• MemorialCare Saddleback Medical Center — Laguna Hills, California, United States (enrolling)

Full record on ClinicalTrials.gov

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