Lay Title: EXCALIBUR study for Prostate Cancer
Technical Title: EXtremely HypofraCtionAted Intensity ModuLated StereotactIc Body Radiotherapy for AdJUvant or Salvage Treatment for Rising PSA after Radical Prostatectomy (EXCALIBUR)
Basic Information: This study will provide external beam radiation therapy over 5 “fractions,” or separate treatments, to men who have had or are planning to have their prostates removed due to prostate cancer. This treatment regimen, known as stereotactic body radiotherapy, or “SBRT,” differs from routine regimens which may require up to as many as 45 separate treatments to receive the same total radiation dose.
Due to the lower number of treatment visits, SBRT is considered more convenient than these other regimens.. While all radiotherapy has side effects, this study is designed to explore whether SBRT will have comparable side effects as other regimens.
Research Procedures (not a complete list):
A routine consultation and initial work-up with a doctor, including a physical exam, review of your medical history and pathology records, the drawing of routine blood to measure your PSA, administration of a questionnaire which asks about your current quality of life.
Routine radiotherapy planning which will include a CT scan and/or an MRI scan.
SBRT, which provides radiation over five separate visits, each visit which takes about an hour.
Routine follow-up visits once every three months after treatment for the first two years, and then every six months thereafter for the next three years. These visits will include a brief physical exam and completion of quality of life questionnaires. On occasion, blood collected for routine medical tests, and CT scans or MRIs may take place.
Inclusion Criteria (not a complete list):
(a) Adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, OR presence of tertiary Gleason grade 5 disease)
(b) Documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL
(c) Intermediate- or high-risk Decipher genomic classifier score
(d) Identification of prostate cancer in ≥1 lymph node at the time of prostatectomy (pN+ disease)
Exclusion Criteria (not a complete list):
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