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Radiation Therapy

SBRT for Prostate Cancer

N/A

Recruiting

Led By Fabio Cury, MD

Research Sponsored by Fabio Cury

Eligibility Criteria Checklist

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

Must have

Age >: 18

International Prostate Symptom Score <16 Prostate gland volume< 80cc

Must not have

Evidence of distant metastases

Previous or concurrent cytotoxic chemotherapy for prostate cancer Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the last 6 months Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. (Patients on Coumadin or other blood thinning agents are eligible for this study.) Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether it is safe to give one big dose of radiation to the prostate while keeping the rectum healthy by using a hydrogel.

Who is the study for?

Men over 18 with low to favorable intermediate-risk prostate cancer, a recent PSA under 15 ng/dL, Gleason score of 6 or 7(3+4), and good performance status. They must not have had previous radical prostate treatments, hormonal therapies, or chemotherapy for prostate cancer and should be free from distant metastases and severe health conditions.

What is being tested?

The trial is testing a one-time Stereotactic Body Radiation Therapy (SBRT) treatment in patients who've had SpaceOAR hydrogel inserted to increase space between the prostate and rectum. It's a phase I study focusing on safety for those with specific types of early-stage prostate cancer.

What are the potential side effects?

While side effects are not detailed here, SBRT may commonly cause urinary issues, bowel discomfort, fatigue, skin reactions in the treated area, erectile dysfunction and might also lead to more serious but rare complications.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 18 years.

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My prostate symptoms are mild and my prostate is small.

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My prostate cancer is confirmed, not very aggressive, and my recent PSA level is below 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to distant parts of my body.

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You have had chemotherapy for prostate cancer in the past or currently have severe health problems that could interfere with the study, such as recent heart attack or hospitalization for heart or lung issues. You also have liver disease with jaundice or coagulation problems. If you have HIV or other immune system problems, you may not be eligible for this study.

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My cancer has spread to nearby lymph nodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Bladder complications

Small bowel or rectal irritation

Secondary study objectives

PSA control

To assess late GI and GU toxicity

Side effects data

From 2018 Phase 2 trial • 35 Patients • NCT01360593

21%

Anemia

18%

Neutropenia

15%

Hypoalbuminemia

15%

White blood cell decreased ( leukopenia)

15%

Diarrhea

12%

Liver Dysfunction

Hand-Foot

Bleeding

Stroke

Abdominal Infection

Ileus

Mucositis

Edema

Dermatitis

Platelet count decreased ( Thrombocytopenia)

100%

80%

60%

40%

20%

Study treatment Arm

Gem + Xeloda + SBRT

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: Single Fraction SBRT in the treatment of prostate cancerExperimental Treatment1 Intervention

Prior to treatment, a hydrogel spacer will be inserted between the recutm and prostate. A urinary catheter will also be inserted in the bladder. A single dose of 19Gy will be delivered with an IMRT technique. The treatment should last approximately 30 minutes. After the treatment, the urinary catheter will be removed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy (SBRT)

2018

Completed Phase 2

~950

0 / 6Eligibility criteria met