102 Participants Needed

Stereotactic Radiotherapy + Hormone Therapy for Prostate Cancer

(EXCALIBUR Trial)

BC
VB
Overseen ByVince Basehart
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that stereotactic ablative radiotherapy (SABR) using the CyberKnife system is effective and safe for treating intermediate- to very-high-risk prostate cancer, and it may improve survival and delay further metastases in patients with oligometastatic prostate cancer.12345

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 U. Kishan, MD - Radiation Oncology ...

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

I can take care of myself but may not be able to do active work.
I had surgery to remove prostate cancer.
My cancer has an intermediate or high risk based on the Decipher test.
See 7 more

Exclusion Criteria

I have a history of Crohn's disease, ulcerative colitis, or ataxia telangiectasia.
I have had radiation therapy to my pelvic area before.
My cancer has spread to distant parts of my body.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

2 weeks

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.

5 years
Every 3 months for the first year, then every 6 months

Treatment Details

Interventions

  • Hormone Therapy
  • Stereotactic Body Radiation Therapy
Trial OverviewThe trial is testing a high-precision radiation therapy called Stereotactic Body Radiation Therapy (SBRT) combined with Hormone Therapy to see if it can treat prostate cancer more effectively with fewer treatments and less damage to healthy tissue.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (SBRT, hormone therapy)Experimental Treatment2 Interventions
Patients undergo SBRT every other day or on consecutive days for up to 14 days. Patients may receive hormonal therapy at the discretion of the treating physician.

Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials
373
Recruited
35,200+

Findings from Research

CyberKnife stereotactic ablative radiotherapy (SABR) for treating intermediate- to very-high-risk prostate cancer showed a high 3-year biochemical relapse-free survival rate of 90.2%, indicating its efficacy in managing this condition.
The treatment was well-tolerated, with no patients experiencing severe toxicity (≥ grade 3), and only mild genitourinary and gastrointestinal side effects were reported, suggesting a favorable safety profile.
Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results.Fan, CY., Chao, HL., Huang, WY., et al.[2017]
In a study of 87 men with oligometastatic prostate cancer treated with stereotactic ablative radiotherapy (SABR), the median disease-free survival (DMFS) was 21.8 months for hormone-sensitive patients, indicating a significant benefit from this treatment.
Combining SABR with short-term androgen-deprivation therapy improved both biochemical progression-free survival (bPFS) and DMFS in patients with oligorecurrent hormone-sensitive prostate cancer, suggesting a potential strategy for enhancing treatment outcomes.
Survival Outcomes and Pattern of Relapse After SABR for Oligometastatic Prostate Cancer.Mercier, C., Claessens, M., De Troyer, B., et al.[2022]
A single session of stereotactic ablative body radiotherapy (SABR) for oligometastatic prostate cancer was found to be feasible and safe, with only one significant adverse event (a vertebral fracture) reported among 33 patients over a 2-year follow-up period.
The treatment resulted in high local progression-free survival rates of 97% at 1 year and 93% at 2 years, with nearly half of the patients (48%) avoiding the need for androgen deprivation therapy at the 2-year mark, indicating effective disease control and maintained quality of life.
Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial.Siva, S., Bressel, M., Murphy, DG., et al.[2022]

References

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]
Survival Outcomes and Pattern of Relapse After SABR for Oligometastatic Prostate Cancer. [2022]
Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. [2022]
Two versus five stereotactic ablative radiotherapy treatments for localized prostate cancer: A quality of life analysis of two prospective clinical trials. [2020]
Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. [2018]
Cyberknife Radioablation of Prostate Cancer – Preliminary Results for 400 Patients [2020]
Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]
Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. [2022]
Low incidence of new biochemical and clinical hypogonadism following hypofractionated stereotactic body radiation therapy (SBRT) monotherapy for low- to intermediate-risk prostate cancer. [2022]
Stereotactic body radiotherapy for prostate cancer: a preliminary report. [2022]