SBRT Boost for Unfavorable Prostate Cancer’
Prospective Evaluation of Stereotactic Body Radiotherapy Boost for Unfavorable Localized Prostate Cancer
About This Trial
- This clinical trial is testing a precise, high-dose type of radiation to see if it safely and effectively treats prostate cancer without the use of needles or surgery.
- It is designed for men with prostate cancer that has not spread to distant parts of the body and who have not had previous prostate radiation or surgery.
- Researchers want to learn how well this focused approach controls the cancer, what side effects it may cause, and how it impacts your overall quality of life.
- Before joining, you should know that you will need recent imaging and biopsy results, and you will be asked to complete questionnaires tracking your health and well-being throughout the study.
More Information
- The purpose of this study is to find out whether giving a short course of focused radiation called an SBRT "boost" is a safe and effective way to treat prostate cancer.
- This boost delivers a high dose of radiation to the prostate in a non-invasive way, similar to what is done with high dose rate (HDR) brachytherapy but without using needles.
- The study looks at how well this treatment controls the cancer, what side effects it may cause, and how it affects patients' quality of life over time.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This clinical trial is testing a precise, high-dose type of radiation to see if it safely and effectively treats prostate cancer without the use of needles or surgery.
Study Details
- Start Date: June 2012
- Lead Sponsor: MemorialCare Health System
Full Eligibility Criteria
Inclusion
- 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 VERSION 9)
- M-stage determined by physical exam, CT, MRI, bone scan, PSMA PET/CT, or biopsy.
- Prostate volume: ≤ 100 cc (recommended not required)
- Determined using: volume = π/6 x length x height x width
- Measurement from CT, MRI or ultrasound ≤ 90 days prior to registration.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- No prior prostatectomy or cryotherapy of the prostate
- No prior radiotherapy to the prostate or lower pelvis
- No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
- Completion of patient questionnaires in section 3.7.
- Consent signed Exclusion
- No prior prostatectomy or cryotherapy of the prostate
- No prior radiotherapy to the prostate or lower pelvis
- No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
Treatments
- Radiation: Stereotactic body radiotherapy (SBRT) Boost