A phase I trial to determine the safety of delivering three sequentially shorter RT schedules (20, 16, and 12 fractions) of HypoFx pelvic nodal RT in combination with a HypoFx, simultaneous integrated boost (SIB) to the prostate that have been designed to incrementally increased the biological equivalent dose (BED) to prostate cancer, while maintaining a constant BED to normal tissue toxicity.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Patient age is ≥ 18 years
✓. Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration.
✓. Patient's with intermediate to high risk prostate cancer and must be recommended to undergo pelvic as well as prostatic irradiation.
✓. History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration.
✓. Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MR), (but not by nodal sampling, or dissection) within 120 days prior to registration.
✓. No evidence of bone metastases (M0) on bone scan within 120 days prior to registration.
✓. Baseline serum PSA value performed within 12 weeks (90 days) prior to registration.
✓. ECOG Performance Status 0-1
Exclusion criteria
✕. Evidence of distant metastases
✕. Regional lymph node involvement
✕. Previous radical surgery (prostatectomy), cryosurgery, or HIFU (High-intensity focused ultrasound) for prostate cancer
✕. Previous pelvic irradiation or prostate brachytherapy
What they're measuring
1
HypoFx RT schedule that results in <33% acute dose-limiting toxicity with accelerated, HypoFx pelvic nodal RT
✕. Previous or concurrent cytotoxic chemotherapy for prostate cancer
✕. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
✕. Patients are excluded if they have a history of autoimmune disease that, in the opinion of the treating physician would be a contraindication to pelvic radiation (e.g., active systemic lupus, progressive scleroderma)