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Radiation Therapy

SBRT for Localized Prostate Cancer Post-Surgery

Phase 2

Waitlist Available

Led By Amar Kishan, MD

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

Presence of adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, presence of tertiary Gleason grade 5 disease) OR documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL

Karnofsky performance score (KPS) >= 70

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will study how well SBRT works in treating patients with prostate cancer that has not spread & have undergone surgery.

Who is the study for?

Men with localized prostate cancer treated by surgery can join this trial. They must have a history of adenocarcinoma, no distant metastases, and not received prior pelvic radiotherapy or certain other prostate treatments. A Karnofsky score of 70+ (able to care for themselves) and rising PSA levels post-surgery are required.Check my eligibility

What is being tested?

The trial is testing stereotactic body radiation therapy (SBRT), which targets the tumor with high-precision x-rays over several days, potentially sparing healthy tissue. It's for patients whose cancer hasn't spread and includes antiandrogen therapy and quality-of-life assessments.See study design

What are the potential side effects?

Potential side effects include skin irritation at the treatment site, fatigue, urinary issues like increased frequency or discomfort, bowel changes such as diarrhea or rectal bleeding, erectile dysfunction, and less commonly inflammation of surrounding organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer surgery showed high-risk features or my PSA levels are rising.

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I am able to care for myself but may not be able to do active work.

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I had surgery to remove prostate cancer.

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

Biochemical recurrence-free survival (BCRFS)

Patient-reported toxicity outcomes EPIC-26

Patient-reported toxicity outcomes IPSS

+1 more

Secondary outcome measures

Proportion of stereotactic body radiation therapy (SBRT) fractions for which on-line adaptive radiotherapy was utilized in the subset of patient treated with magnetic resonance imaging (MRI)-guided radiotherapy

Other outcome measures

Patient-reported toxicity outcomes; patients treated utilizing a linear accelerator

Patient-reported toxicity profiles patients treated utilizing the magnetic resonance imaging (MRI)-guided device

Physician-scored Toxicity profiles patients treated utilizing a linear accelerator

+1 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

Dehydration

Blurred vision

Sinusitis

Dysgeusia

Hemorrhoids

Amnesia

Confusion

Otitis externa

Creatinine increased

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (SBRT, ADT)Experimental Treatment3 Interventions

Patients undergo SBRT QOD for 14 days. Patients may also receive ADT comprised of a luteinizing hormone-releasing hormone agonist or a gonadotropin-releasing hormone antagonist, and an oral anti-androgen for 6 months at the discretion of the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Antiandrogen Therapy

2015

Completed Phase 1

~10

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

25,958 Total Patients Enrolled

39 Trials studying Prostate Cancer

4,000 Patients Enrolled for Prostate Cancer

Viewray Inc.Industry Sponsor

12 Previous Clinical Trials

997 Total Patients Enrolled

2 Trials studying Prostate Cancer

270 Patients Enrolled for Prostate Cancer

Amar Kishan, MDPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

1 Previous Clinical Trials

93 Total Patients Enrolled

Media Library

Stereotactic Body Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03541850 — Phase 2

Prostate Cancer Research Study Groups: Treatment (SBRT, ADT)

Prostate Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy Highlights & Side Effects. Trial Name: NCT03541850 — Phase 2

Stereotactic Body Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03541850 — Phase 2

Frequently Asked Questions

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

How often do patients experience negative side effects from Stereotactic Body Radiation Therapy?

"While Phase 2 trials are not as robust as Phase 3 trials in terms of safety data, our team still believes that Stereotactic Body Radiation Therapy is safe enough to warrant a score of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery

2019. "Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03541850.

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