Trial Summary
What is the purpose of this trial?This clinical trial studies stereotactic body radiation therapy in treating patients with high-risk prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Studying quality of life in patients undergoing stereotactic body radiation therapy may help identify the long-term effects of treatment on patients with prostate cancer.
Eligibility Criteria
This trial is for men with high-risk prostate cancer that hasn't spread beyond the prostate or to lymph nodes. Participants must have a Karnofsky performance status of 70 or above, indicating they can care for themselves. They should not have had extensive hormone therapy, prior cryosurgery, HIFU, brachytherapy, pelvic radiotherapy, nor suffer from Crohn's disease or Ulcerative colitis.Inclusion Criteria
I have chosen SBRT as my main cancer treatment.
Ability to understand, and willingness to sign, the written informed consent
Risk-group classification into the D’Amico or National Comprehensive Cancer Network (NCCN) ‘high-risk’ group based on specific criteria
+3 more
Exclusion Criteria
I have been on hormonal therapy for more than 4 months.
I have had radiation therapy to my pelvic area before.
I have a history of Crohn's disease or Ulcerative colitis.
+2 more
Participant Groups
The study tests stereotactic body radiation therapy (SBRT) on patients with localized high-risk prostate cancer. SBRT delivers a concentrated dose of radiation aiming to kill more tumor cells while sparing healthy tissue. The trial also assesses how this treatment affects patients' quality of life and monitors changes through lab biomarker analysis.
1Treatment groups
Experimental Treatment
Group I: Treatment (SBRT)Experimental Treatment4 Interventions
Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 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:
🇺🇸 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
🇪🇺 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
🇨🇦 Approved in Canada as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
🇦🇺 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:
Jonsson Comprehensive Cancer CenterLos Angeles, CA
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Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer CenterLead Sponsor