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Radiation

Arm I (SBRT) for Prostate Cancer

Phase 3

Recruiting

Led By Karen E Hoffman

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or computed tomography (CT) scan

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

Study Summary

This trial is comparing two different types of radiation therapy for high-risk prostate cancer. One type, called stereotactic body radiation therapy (SBRT), involves giving higher doses of radiation over a shorter period

Who is the study for?

This trial is for men with high-risk prostate cancer confirmed by tests, a PSA level over 20 ng/mL, Gleason Score of 8-10, and certain conditions on imaging. Participants must have a prostate size under 100 cc without evidence of distant metastases. Men should be at least 18 years old with an ECOG Performance Status of 0-2 and no prior radiation in the same area.Check my eligibility

What is being tested?

The study compares two types of radiation therapy: SBRT (five treatments over two weeks) versus usual radiation (20 to 45 treatments over four to nine weeks). It aims to see if the shorter SBRT prevents cancer return as effectively as the longer usual treatment.See study design

What are the potential side effects?

Radiation therapy can cause side effects such as fatigue, skin reactions in treated areas, urinary issues like increased frequency or discomfort, bowel changes including diarrhea or pain, and potential sexual dysfunction.

Eligibility Criteria

Inclusion Criteria

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

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My prostate gland is smaller than 100 cc before starting hormone therapy.

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I can take care of myself and am up and about more than half of my waking hours.

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My prostate cancer diagnosis was confirmed through lab tests.

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My cancer has not spread beyond my pelvic nodes according to scans.

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My pelvic lymph nodes are enlarged, measuring at least 1.0 cm.

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My cancer is classified as cT3a-T3b, not cT4, based on exams or imaging.

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My prostate cancer is aggressive (Gleason Score 8-10).

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I haven't had radiation in the area where my current cancer is.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 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

Metastasis-Free Survival (MFS)

Secondary outcome measures

Bowel domain of the Expanded Prostate Cancer Index Composite (EPIC-26)

Cost

Failure-Free Survival

+6 more

Other outcome measures

Patient-reported outcomes

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

Otitis externa

Sinusitis

Dysgeusia

Hemorrhoids

Amnesia

Confusion

Dementia

Productive cough

Dysuria

White blood cell count decreased

Throat pain

Bone marrow biopsy

Hearing impaired

Rash

Hypernatremia

Eye pain

Blurred vision

Tachycardia

Lung infection

Neuropathy

Hypertension

Pleuritic pain

Neutropenia

Dehydration

Pneumonitis

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

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (SBRT)Experimental Treatment1 Intervention

Patients undergo SBRT for a total of 5 treatments over 2 weeks.

Group II: Arm II (EBRT)Active Control1 Intervention

Patients undergo EBRT for 20 to 45 treatments over 4 to 9 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,925,232 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,095 Patients Enrolled for Prostate Cancer

NRG OncologyLead Sponsor

231 Previous Clinical Trials

99,643 Total Patients Enrolled

20 Trials studying Prostate Cancer

12,301 Patients Enrolled for Prostate Cancer

Karen E HoffmanPrincipal InvestigatorNRG Oncology

Frequently Asked Questions

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

Has the Food and Drug Administration granted official approval for Arm I (SBRT) treatment?

"Arm I (SBRT) has been assigned a rating of 3 by our team at Power, indicating that there is substantial evidence supporting its safety. This rating aligns with the fact that this trial is in Phase 3 and has accumulated multiple rounds of data validating its efficacy and safety measures."

Answered by AI

Is this clinical trial currently accepting new participants?

"Indeed, according to the information available on clinicaltrials.gov, this research study is currently actively seeking eligible participants. The trial was initially posted for recruitment purposes on November 13th, 2023 and has been recently updated as of December 21st, 2023."

Answered by AI

What is the current number of individuals being admitted into this particular medical trial?

"Indeed, the information available on clinicaltrials.gov confirms that this investigation is actively seeking eligible participants. The trial was initially posted on November 13th, 2023 and recently updated on December 21st, 2023. A total of 40 sites are involved in recruiting approximately 1209 patients for this study."

Answered by AI

Are there numerous medical facilities within the state conducting this study?

"As part of this clinical trial, there are currently 40 active centers participating. These include sites such as Kaiser Permanente-Rancho Cordova Cancer Center located in Rancho Cordova, South Sacramento Cancer Center situated in Sacramento, and Kaiser Permanente-Fresno based in Fresno. Additionally, there are another 40 locations that are also involved in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer

2023. "Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05946213.

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