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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
Must not have
History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
Prior pelvic radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but may not be able to do active work.
Select...
I had surgery to remove prostate cancer.
Select...
My cancer has an intermediate or high risk based on the Decipher test.
Select...
My prostate cancer was found in at least one lymph node during surgery.
Select...
My PSA levels have been rising on two or more tests, each above 0.03 ng/mL.
Select...
I am 18 years old or older.
Select...
My prostate cancer surgery showed high-risk features.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of Crohn's disease, ulcerative colitis, or ataxia telangiectasia.
Select...
I have had radiation therapy to my pelvic area before.
Select...
My prostate cancer is of the neuroendocrine or small cell type.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreSide effects data
From 2022 Phase 2 trial • 29 Patients • NCT0204544687%
Fatigue
53%
Nausea
33%
Cough
27%
Depression
27%
Pain
27%
Anemia
27%
Dyspnea
27%
Lymphocyte count decreased
27%
Platelet count decreased
27%
Fall
20%
Chest pain
20%
Chills
20%
Neutropenia
20%
Diarrhea
20%
Dizziness
20%
Edema limbs
13%
Dysgeusia
13%
Constipation
13%
Skin infection
13%
Back pain
13%
Dysesthesia
13%
Rash
13%
Myalgia
13%
Edema
13%
Delirium
13%
Weakness (limb)
13%
Tinnitus
13%
Vomiting
13%
Weight loss
13%
Insomnia
7%
Tremor
7%
Lung infection
7%
Urinary frequency
7%
Hypoxia
7%
Seizures
7%
Amnesia
7%
Hearing loss
7%
Hypoxic respiratory failure
7%
Allergy (seasonal)
7%
Urinary urgency
7%
Erythema multitforme
7%
Proteinuria
7%
Encephalopathy
7%
Acute kidney injury
7%
Dysphagia
7%
Lymphocytopenia
7%
Cognitive disturbance
7%
Nasal congestion
7%
Neutrophil count decreased
7%
Headaches
7%
Hearing impaired
7%
Bruising
7%
Death NOS
7%
Febrile Neutropenia
7%
Muscle weakness
7%
Sneezing
7%
Hypertension
7%
Pleural effusion
7%
Photophobia
7%
Anorexia
7%
Anxiety
7%
Creatinine increased
7%
Hypokalemia
7%
Hypomagnesemia
7%
Parathesia (tingling)
7%
Sleep apnea
7%
Shingles
7%
Fever
7%
Gait disturbance
7%
Headache
7%
Hypernatremia
7%
Oral lesions
7%
Low white blood count
7%
Weakness (facial)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Chemotherapy
Stereotactic Body Radiation Therapy
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but may not be able to do active work.I have a history of Crohn's disease, ulcerative colitis, or ataxia telangiectasia.I had surgery to remove prostate cancer.I have had radiation therapy to my pelvic area before.My cancer has an intermediate or high risk based on the Decipher test.I've had a bone scan or similar test within the last 4 months because my PSA level is over 1.0.My prostate cancer was found in at least one lymph node during surgery.My cancer has spread to distant parts of my body.My PSA levels have been rising on two or more tests, each above 0.03 ng/mL.My prostate cancer is of the neuroendocrine or small cell type.I am 18 years old or older.My prostate cancer surgery showed high-risk features.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (SBRT, hormone therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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