TrueBeam targeted high-dose radiation for localized prostate cancer

Prospective Evaluation of TRUEBEAM Stereotactic Body Radiotherapy for Localized Prostate Cancer: Risk Stratified MonoTherapy Versus RADIOSURGERY Boost

This tests whether TrueBeam focused high-dose radiation can treat men with localized prostate cancer and how it affects their quality of life over time.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 167 (estimated)
• Sex: Male
• Sponsor: MemorialCare Health System (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Laguna Hills, California)
• Trial ID: NCT04552509 on ClinicalTrials.gov

What this trial studies

This interventional protocol uses the TrueBeam stereotactic body radiotherapy (SBRT) system to deliver highly focused, high-dose radiation to the prostate while minimizing dose to surrounding normal tissue. Treatment uses orthogonal X-ray guidance and implanted fiducial markers to achieve sub-millimeter targeting accuracy and a conformal three-dimensional treatment volume. Eligible patients have histologically proven prostate adenocarcinoma (clinical stage I-IV, M0) with recommended prostate volume ≤100 cc and undergo a course of SBRT delivered in a small number of high-dose fractions. Outcomes tracked include local tumor control, treatment-related side effects, and longitudinal quality-of-life measures.

Who should consider this trial

Good fit: Ideal candidates are men with localized, non-metastatic prostate adenocarcinoma who meet imaging and prostate-volume criteria and are appropriate for a hypofractionated SBRT approach.

Not a fit: Patients with known metastatic disease (M1), very large prostate volumes exceeding the recommended limit, or clinical factors that preclude SBRT are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could offer effective cancer control with fewer treatment visits and reduced radiation exposure to nearby normal tissues.

How similar studies have performed: Multiple published trials of prostate SBRT have shown promising tumor control and acceptable toxicity profiles, so this approach builds on an existing evidence base rather than being entirely untested.

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.

Where this trial is running

Laguna Hills, California

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

Study contacts

• Principal investigator: Linda Chan, MD — Memorial Health Services
• Study coordinator: Linda Chan, MD

Conditions Prostate Cancer