← Back to Search

Radiation

Stereotactic Body Radiation Therapy for Prostate Cancer

Phase 2

Waitlist Available

Led By Comron Hassanzadeh, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study Summary

"This trial is studying whether a type of radiation therapy called stereotactic body radiation therapy (SBRT) is safe and effective for treating advanced or high-risk prostate cancer."

Who is the study for?

This trial is for men over 18 with advanced or high-risk prostate cancer that hasn't spread to other parts of the body. They should have a certain level of physical fitness (ECOG 0-2) and a specific grade of tumor severity (Gleason Grade Group 2-5). Prior hormone treatment for prostate cancer is okay if it started less than about six months ago.Check my eligibility

What is being tested?

The PRORAD-5 study tests how safe and effective Stereotactic Body Radiation Therapy (SBRT) is in treating advanced prostate cancer. SBRT delivers precise, high-dose radiation to the tumor in fewer sessions compared to traditional therapy.See study design

What are the potential side effects?

Potential side effects from SBRT may include urinary issues like burning or increased frequency, bowel changes such as diarrhea, fatigue, skin reactions in treated areas, and erectile dysfunction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and adverse events (AEs)

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%

Anorexia

21%

Lymphocyte count decreased

21%

Chest pain

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

Throat pain

Bone marrow biopsy

Hearing impaired

Rash

Hypernatremia

Eye pain

Blurred vision

White blood cell count decreased

Tachycardia

Lung infection

Neuropathy

Hypertension

Neutropenia

Dehydration

Pneumonitis

Pleuritic pain

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: Stereotactic Body Radiation TherapyExperimental Treatment1 Intervention

Participants will then be scheduled to receive radiation therapy. Radiation will be given over 5 sessions, 2-3 times per week, for 2 weeks. Each radiation therapy session will take 15-30 minutes to complete. Within 1 day after completing radiation therapy, blood (about 2 tablespoons) will be drawn for routine tests.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,975 Previous Clinical Trials

1,789,449 Total Patients Enrolled

96 Trials studying Prostate Cancer

29,740 Patients Enrolled for Prostate Cancer

Comron Hassanzadeh, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

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

Are there ongoing efforts to actively enroll participants for this clinical trial?

"According to clinicaltrials.gov, recruitment for this trial is closed. The study was initially posted on October 31st, 2024 and last updated on April 12th, 2024. Although this specific trial is no longer accepting participants, there are currently 1293 active trials seeking candidates at present."

Answered by AI

What are the risks associated with Stereotactic Body Radiation Therapy for individuals undergoing treatment?

"Our assessment at Power Research assigns a safety score of 2 to Stereotactic Body Radiation Therapy due to the ongoing Phase 2 trial lacking efficacy data but showing some level of safety evidence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRORAD-5 PROstate RADiation in 5 Fractions: Phase Ib Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer

2024. "PRORAD-5 PROstate RADiation in 5 Fractions: Phase Ib Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06369246.

All > Advanced Prostate Cancer