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Radiation

SBRT for Prostate Cancer

Phase 2

Recruiting

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

No Placebo-Only Group

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.

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.

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

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

Primary study objectives

Safety and adverse events (AEs)

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%

Dizziness

20%

Chills

20%

Edema limbs

20%

Chest pain

20%

Neutropenia

20%

Diarrhea

13%

Dysesthesia

13%

Edema

13%

Insomnia

13%

Constipation

13%

Delirium

13%

Dysgeusia

13%

Myalgia

13%

Skin infection

13%

Vomiting

13%

Tinnitus

13%

Rash

13%

Back pain

13%

Weakness (limb)

13%

Weight loss

Bruising

Hearing loss

Anxiety

Headaches

Oral lesions

Weakness (facial)

Neutrophil count decreased

Acute kidney injury

Hypokalemia

Lymphocytopenia

Seizures

Hearing impaired

Hypernatremia

Creatinine increased

Headache

Death NOS

Gait disturbance

Nasal congestion

Fever

Tremor

Urinary urgency

Hypoxic respiratory failure

Amnesia

Photophobia

Pleural effusion

Urinary frequency

Dysphagia

Low white blood count

Sneezing

Cognitive disturbance

Erythema multitforme

Lung infection

Hypertension

Allergy (seasonal)

Muscle weakness

Proteinuria

Hypomagnesemia

Parathesia (tingling)

Febrile Neutropenia

Anorexia

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: 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

~790

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