TRUEBEAM Stereotactic Body Radiotherapy for Localized Prostate Cancer
Prospective Evaluation of TRUEBEAM Stereotactic Body Radiotherapy for Localized Prostate Cancer: Risk Stratified MonoTherapy Versus RADIOSURGERY Boost
About This Trial
- This study is testing a highly targeted radiation treatment designed to deliver strong doses directly to prostate tumors while protecting nearby healthy tissue.
- It is for men with prostate cancer that has not spread to other parts of the body and who have not previously had radiation or surgery on their prostate.
- Even though this technique is sometimes called radiosurgery, it is completely non-invasive and involves no cutting or physical surgery.
- Researchers are studying how well the treatment works and how it affects everyday quality of life, though this study is currently closed to new participants.
More Information
- 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.
Who Can Enroll
- Gender: Male
- Who This Trial is For: This study is testing a highly targeted radiation treatment designed to deliver strong doses directly to prostate tumors while protecting nearby healthy tissue.
Study Details
- Start Date: June 5, 2018
- Lead Sponsor: Linda Chan, MD
Full Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Treatments
- Radiation: Stereotactic Body Radiotherapy