Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Men with localized prostate cancer treated by surgery can join this trial. They must have a history of adenocarcinoma, no distant metastases, and not received prior pelvic radiotherapy or certain other prostate treatments. A Karnofsky score of 70+ (able to care for themselves) and rising PSA levels post-surgery are required.Inclusion Criteria
My prostate cancer surgery showed high-risk features or my PSA levels are rising.
I am able to care for myself but may not be able to do active work.
I had surgery to remove prostate cancer.
Exclusion Criteria
My prostate cancer is of the neuroendocrine or small cell type.
I have had cryosurgery, HIFU, or brachytherapy for prostate cancer.
I have had radiation therapy to my pelvic area before.
My prostate cancer has spread to nearby lymph nodes.
I have a history of Crohn's disease, ulcerative colitis, or ataxia telangiectasia.
My cancer has spread to distant parts of my body.
Treatment Details
The trial is testing stereotactic body radiation therapy (SBRT), which targets the tumor with high-precision x-rays over several days, potentially sparing healthy tissue. It's for patients whose cancer hasn't spread and includes antiandrogen therapy and quality-of-life assessments.
1Treatment groups
Experimental Treatment
Group I: Treatment (SBRT, ADT)Experimental Treatment3 Interventions
Patients undergo SBRT QOD for 14 days. Patients may also receive ADT comprised of a luteinizing hormone-releasing hormone agonist or a gonadotropin-releasing hormone antagonist, and an oral anti-androgen for 6 months at the discretion of the treating physician.
Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada, Australia for the following indications:
πΊπΈ Approved in United States as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
πͺπΊ Approved in European Union as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
π¨π¦ Approved in Canada as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
π¦πΊ Approved in Australia as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
Find a clinic near you
Research locations nearbySelect from list below to view details:
USC Norris Comprehensive Cancer Center and HospitalLos Angeles, CA
UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, CA
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Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
Viewray Inc.Industry Sponsor