Stereotactic Radiotherapy + Hormone Therapy for Prostate Cancer
(EXCALIBUR Trial)
Trial Summary
What is the purpose of this trial?
This phase II trial investigates the effect of extremely hypofractionated intensity modulated stereotactic body radiotherapy in treating patients with prostate cancer that has rising prostate specific antigen (PSA) after radical prostatectomy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Stereotactic Radiotherapy + Hormone Therapy for Prostate Cancer?
Is Stereotactic Radiotherapy with Hormone Therapy safe for prostate cancer treatment?
Stereotactic Ablative Radiotherapy (SABR) using the CyberKnife system has been shown to be generally safe for treating prostate cancer, with very few severe side effects reported. Most patients experienced only mild to moderate side effects, and no severe long-term adverse effects were observed in the studies.15678
How is the treatment Stereotactic Body Radiation Therapy (SBRT) with CyberKnife different from other prostate cancer treatments?
Stereotactic Body Radiation Therapy (SBRT) with CyberKnife is unique because it delivers highly precise radiation to prostate cancer using hundreds of non-coplanar beams, which allows for targeting the tumor while minimizing damage to surrounding healthy tissue. This precision makes it a promising option for treating various risk levels of prostate cancer, including low-risk and oligometastatic cases.123910
Research Team
Amar Kishan
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Eligibility Criteria
Men over 18 with prostate cancer that's come back after surgery, shown by rising PSA levels. They should have had certain adverse features at the time of surgery or found cancer in lymph nodes. No prior pelvic radiotherapy, no distant metastases, and no specific other cancers or conditions like Crohn's disease.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo stereotactic body radiotherapy (SBRT) every other day or on consecutive days for up to 14 days. Hormonal therapy may be administered at the discretion of the treating physician.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits every 3 months for the first year, and then every 6 months for up to 5 years.
Treatment Details
Interventions
- Hormone Therapy
- Stereotactic Body Radiation Therapy
Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada for the following indications:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor