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Stereotactic Radiotherapy + Hormone Therapy for Prostate Cancer (EXCALIBUR Trial)

Phase 2
Recruiting
Led By Amar Kishan
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky performance status (KPS) >= 70 and/or Eastern Cooperative Oncology Group (ECOG) =< 2
History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

EXCALIBUR Trial Summary

This trial is testing a new, more precise way of doing radiation therapy that may be more effective and have fewer side effects than the current standard.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects may include skin reactions, fatigue, urinary issues such as increased frequency or discomfort, bowel changes like diarrhea or rectal bleeding, and erectile dysfunction due to the targeted area.

EXCALIBUR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but may not be able to do active work.
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I had surgery to remove prostate cancer.
Select...
My cancer has an intermediate or high risk based on the Decipher test.
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My prostate cancer was found in at least one lymph node during surgery.
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My PSA levels have been rising on two or more tests, each above 0.03 ng/mL.
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I am 18 years old or older.
Select...
My prostate cancer surgery showed high-risk features.

EXCALIBUR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of Expanded Prostate Cancer Index (EPIC) score for the gastrointestinal domain
Change of Expanded Prostate Cancer Index (EPIC) score for the genitourinary domain
Secondary outcome measures
Cumulative incidence of biochemical recurrence
Cumulative incidence of physician scored adverse events
Distant metastasis-free survival
+4 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446
79%
Cough
64%
Nausea
64%
Dyspnea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Back pain
29%
Anemia
29%
Vomiting
21%
Anorexia
21%
Lymphocyte count decreased
21%
Chest pain
21%
Death NOS
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Dysphagia
14%
Depression
14%
Hypotension
14%
Diarrhea
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Muscle weakness
7%
Alopecia
7%
Hypoxia
7%
Esophagitis
7%
Hemorrhoids
7%
Dementia
7%
Productive cough
7%
Dysuria
7%
Lung infection
7%
Throat pain
7%
Dysgeusia
7%
Hearing impaired
7%
Tachycardia
7%
Bone marrow biopsy
7%
Hypernatremia
7%
Eye pain
7%
Neuropathy
7%
Dehydration
7%
Pneumonitis
7%
Pleuritic pain
7%
Otitis externa
7%
Blood bilirubin increased
7%
Amnesia
7%
Floaters
7%
Confusion
7%
White blood cell count decreased
7%
Neutropenia
7%
Hypertension
7%
Sinusitis
7%
Leukocytosis
7%
Blurred vision
7%
Rash
7%
Creatinine increased
7%
Aspiration pneumonia
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Toothache
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy

EXCALIBUR Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Hormone Therapy
2018
Completed Phase 3
~550

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
365 Previous Clinical Trials
27,846 Total Patients Enrolled
39 Trials studying Prostate Cancer
3,982 Patients Enrolled for Prostate Cancer
Amar KishanPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
5 Previous Clinical Trials
720 Total Patients Enrolled

Media Library

Stereotactic Body Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04915508 — Phase 2
Prostate Cancer Research Study Groups: Treatment (SBRT, hormone therapy)
Prostate Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy Highlights & Side Effects. Trial Name: NCT04915508 — Phase 2
Stereotactic Body Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04915508 — Phase 2
~42 spots leftby Aug 2026