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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

No Placebo-Only Group

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.

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.

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 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.

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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.

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My prostate cancer surgery showed high-risk features.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of Crohn's disease, ulcerative colitis, or ataxia telangiectasia.

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I have had radiation therapy to my pelvic area before.

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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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Cumulative incidence of physician scored adverse events

Incidence of acute physician scored adverse events

Patient-reported gastrointestinal (GI) symptoms

+1 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446

87%

Fatigue

53%

Nausea

33%

Cough

27%

Pain

27%

Fall

27%

Dyspnea

27%

Depression

27%

Lymphocyte count decreased

27%

Platelet count decreased

27%

Anemia

20%

Chills

20%

Dizziness

20%

Chest pain

20%

Neutropenia

20%

Diarrhea

20%

Edema limbs

13%

Dysesthesia

13%

Insomnia

13%

Edema

13%

Constipation

13%

Delirium

13%

Dysgeusia

13%

Skin infection

13%

Vomiting

13%

Tinnitus

13%

Rash

13%

Myalgia

13%

Back pain

13%

Weakness (limb)

13%

Weight loss

Proteinuria

Bruising

Hearing loss

Anxiety

Oral lesions

Headaches

Acute kidney injury

Hypokalemia

Lymphocytopenia

Seizures

Weakness (facial)

Hearing impaired

Neutrophil count decreased

Death NOS

Hypertension

Headache

Creatinine increased

Fever

Pleural effusion

Gait disturbance

Nasal congestion

Tremor

Urinary urgency

Amnesia

Hypernatremia

Photophobia

Urinary frequency

Dysphagia

Low white blood count

Sneezing

Cognitive disturbance

Erythema multitforme

Lung infection

Allergy (seasonal)

Muscle weakness

Hypomagnesemia

Parathesia (tingling)

Febrile Neutropenia

Anorexia

Hypoxic respiratory failure

Sleep apnea

Encephalopathy

Hypoxia

Shingles

100%

80%

60%

40%

20%

Study treatment Arm

Maintenance Chemotherapy

Stereotactic Body Radiation Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Hormone Therapy

2018

Completed Phase 3

~550

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790