TRUEBEAM Stereotactic Body Radiotherapy for Localized Prostate Cancer

Launched by LINDA CHAN, MD · Sep 11, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called TrueBeam stereotactic body radiotherapy for men with prostate cancer. This treatment uses focused, high-energy beams of radiation to target the tumor in the prostate. The goal is to deliver a strong dose of radiation directly to the cancer while protecting the nearby healthy tissues as much as possible. Unlike traditional surgery, this is a non-invasive procedure, meaning no cuts or incisions are made. The study aims to find out how well this treatment works and how it affects patients’ quality of life over time.

Men who may be eligible for this study are those diagnosed with prostate cancer confirmed by a recent biopsy, and their cancer can be at various stages but must not have spread to distant parts of the body. Participants should have a prostate size within certain limits and be in generally good health. Those who have had previous prostate surgery, certain types of radiation therapy, or implanted devices that interfere with treatment are not eligible. If you join the trial, you will receive this specialized radiation treatment and be asked to complete questionnaires to help the researchers understand how the treatment impacts your health and daily life.

Gender

MALE

Eligibility criteria

• • 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.