Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery

• Status: Active, not recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

This phase II trial studies how well stereotactic body radiation therapy works in treating patients with prostate cancer that has not spread to other parts of the body and have undergone surgery. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI); Viewray Inc.
• Treatments: Androgen Antagonists; Androgens; Ascorbic Acid; Estrogens, Conjugated (USP); Hormone Antagonists; Hormones; Methyltestosterone; Prolactin Release-Inhibiting Factors

Criteria

Inclusion Criteria:

• History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent

• Presence of adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, presence of tertiary Gleason grade 5 disease) OR documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL

• Computed tomography (CT) scan and MRI of the pelvis within 120 days prior to enrollment (note: [a] if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed [b] for patients with PSA < 1.0 ng/mL, the treatment planning CT can substitute for a diagnostic CT scan)

• Bone scan within 120 days prior to enrollment; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis, and advanced imaging (e.g., 18NaF positron emission tomography [PET]/CT) is strongly recommended

• Karnofsky performance score (KPS) >= 70

• Ability to understand, and willingness to sign, the written informed consent

Exclusion Criteria:

• Patients with any evidence of distant metastases

• Patients with pathologically-confirmed N1 prostate cancer

• Patients with neuroendocrine or small cell carcinoma of the prostate

• Prior cryosurgery, high-intensity focused ultrasound ablation (HIFU) or brachytherapy of the prostate

• Prior pelvic radiotherapy

• History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia