← Back to Search

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

Q: Are there any current vacancies for this research project?

The study, which you can find more information about on clinicaltrials.gov, is still looking for participants. The post date was June 23rd 2021 and the most recent edit was on July 1st of this year.

Q: Are there any harmful after-effects of Stereotactic Body Radiation Therapy?

Although Phase 2 trials offer preliminary evidence of a treatment's safety, there is no data supporting its efficacy. For this reason, our team has given Stereotactic Body Radiation Therapy a score of 2.

Q: To date, how many individuals have taken part in this research?

The listing on clinicaltrials.gov verifies that the research team is still looking for test subjects. The study was put up on 23 June 2021 and edited most recently on 1 July 2022; they are seeking 102 individuals total at a single site.

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

Select...

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.

EXCALIBUR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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%

Dyspnea

64%

Nausea

57%

Fatigue

43%

Constipation

36%

Pain

36%

Dizziness

29%

Anemia

29%

Back pain

29%

Vomiting

21%

Chest pain

21%

Anorexia

21%

Lymphocyte count decreased

21%

Death NOS

21%

Anxiety

21%

Fall

14%

Wheezing

14%

Dysphagia

14%

Hypotension

14%

Depression

14%

Diarrhea

14%

Platelet count decreased

14%

Abdominal Pain

14%

Edema

14%

Fever

14%

Headache

14%

Insomnia

14%

Palpitations

Alopecia

Creatinine increased

Dehydration

Otitis externa

Blurred vision

Sinusitis

Dysgeusia

Hemorrhoids

Amnesia

Confusion

Dementia

Productive cough

Pneumonitis

Dysuria

White blood cell count decreased

Throat pain

Bone marrow biopsy

Hearing impaired

Rash

Hypernatremia

Eye pain

Hypertension

Tachycardia

Lung infection

Neuropathy

Pleuritic pain

Neutropenia

Hypoxia

Aspiration pneumonia

Blood bilirubin increased

Muscle weakness

Tremor

Weight loss

Thrombocytopenia

Floaters

Toothache

Esophagitis

Leukocytosis

Edema limbs

Gait disturbance

Parathesia (tingling)

Edema face

COPD

100%

80%

60%

40%

20%

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

25,930 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current vacancies for this research project?

"The study, which you can find more information about on clinicaltrials.gov, is still looking for participants. The post date was June 23rd 2021 and the most recent edit was on July 1st of this year."

Answered by AI

Are there any harmful after-effects of Stereotactic Body Radiation Therapy?

"Although Phase 2 trials offer preliminary evidence of a treatment's safety, there is no data supporting its efficacy. For this reason, our team has given Stereotactic Body Radiation Therapy a score of 2."

Answered by AI

To date, how many individuals have taken part in this research?

"The listing on clinicaltrials.gov verifies that the research team is still looking for test subjects. The study was put up on 23 June 2021 and edited most recently on 1 July 2022; they are seeking 102 individuals total at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer With Rising PSA After Radical Prostatectomy

2021. "Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer With Rising PSA After Radical Prostatectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04915508.

All > Prostate Cancer Anaheim