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Radiation Therapy

Stereotactic Body Radiation for Prostate Cancer

N/A

Waitlist Available

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

Histologically confirmed primary non-metastatic adenocarcinoma of the prostate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 5 years

Awards & highlights

Study Summary

This trial is testing if a new type of radiation therapy can better treat prostate cancer without damaging nearby tissue.

Who is the study for?

This trial is for men with high-risk prostate cancer that hasn't spread beyond the prostate or to lymph nodes. Participants must have a Karnofsky performance status of 70 or above, indicating they can care for themselves. They should not have had extensive hormone therapy, prior cryosurgery, HIFU, brachytherapy, pelvic radiotherapy, nor suffer from Crohn's disease or Ulcerative colitis.Check my eligibility

What is being tested?

The study tests stereotactic body radiation therapy (SBRT) on patients with localized high-risk prostate cancer. SBRT delivers a concentrated dose of radiation aiming to kill more tumor cells while sparing healthy tissue. The trial also assesses how this treatment affects patients' quality of life and monitors changes through lab biomarker analysis.See study design

What are the potential side effects?

Potential side effects include damage to surrounding tissues leading to urinary and bowel issues; fatigue; skin reactions in the treated area; and possible sexual dysfunction due to the proximity of treatment areas to reproductive organs.

Eligibility Criteria

Inclusion Criteria

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

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

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My prostate cancer has not spread and was confirmed by a biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 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 progression free survival

Changes in health related quality of life based on Expanded Prostate Cancer Index Composite questionnaire

Incidence of patient-reported GU and GI toxicity based on the CTCAE version 4

+1 more

Side effects data

From 2016 Phase 2 trial • 59 Patients • NCT00087438

55%

Dyspnea

38%

Fatigue

33%

Cough

24%

Hemoglobin

20%

Pulmonary/upper respiratory - Other

16%

Chest wall pain

16%

Fracture NOS

16%

Forced expiratory volume

15%

Pneumonitis NOS

15%

Chest pain

15%

Nausea

11%

Blood/bone marrow - Other

11%

Dermatitis radiation NOS

11%

Blood creatinine increased

Hypoalbuminemia

Hyperglycemia NOS

Pleural effusion

Vomiting NOS

Lymphopenia

Pulmonary function test NOS decreas

Hypocalcemia

Headache

Abdominal pain NOS

Edema: limb

Hypoxia

Blood bilirubin increased

Peripheral sensory neuropathy

Pyrexia

Rigors

Diarrhea NOS

Muscle weakness NOS

Myalgia

Musculoskeletal/soft tissue - Other

Hypokalemia

Atrial fibrillation

Hyponatremia

Pain - Other

Infection with Grade 3 or 4 neutrop

Activated partial thromboplastin ti

Blood alkaline phosphatase increase

Metabolic/laboratory - Other

Weight decreased

Renal/genitourinary - Other

Atelectasis

Anorexia

Insomnia

Dysphagia

Lymphatics - Other

Cardiac general - Other

Constipation

Pulmonary hypertension NOS

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Body Radiation Therapy (SBRT)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (SBRT)Experimental Treatment4 Interventions

Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

androgen deprivation therapy

2004

Completed Phase 3

~650

stereotactic body radiation therapy

2019

Completed Phase 2

~480

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

25,830 Total Patients Enrolled

39 Trials studying Prostate Cancer

4,000 Patients Enrolled for Prostate Cancer

Amar KishanPrincipal InvestigatorJonsson Comprehensive Cancer Center

5 Previous Clinical Trials

602 Total Patients Enrolled

Media Library

Stereotactic Body Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02296229 — N/A

Prostate Cancer Research Study Groups: Treatment (SBRT)

Prostate Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy Highlights & Side Effects. Trial Name: NCT02296229 — N/A

Stereotactic Body Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02296229 — N/A

Frequently Asked Questions

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

Is this experiment open for new participants to join?

"The clinicaltrials.gov portal has reported that this medical experiment is no longer seeking participants, with the initial posting of 1/27/2014 and last update on 4/28/2022. However, there are currently 1259 other studies actively enrolling volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Body Radiation Therapy in Treating Patients With Localized High-Risk Prostate Cancer

2014. "Stereotactic Body Radiation Therapy in Treating Patients With Localized High-Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02296229.