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Radiation

SBRT for Prostate Cancer

Phase 2

Recruiting

Led By Michael Zelefsky, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Two or more of the following risk factors: Grade Group 2 or 3, cT2b-T2c, PSA 10 - 20 ng/mL, Able to undergo MRI for initial staging and MR based radiation planning, Sufficient biopsy tissue available for Decipher genomic testing, Prostate volume < 90cc, IPSS ≤ 20, Age ≥ 18, KPS ≥ or ECOG 0-2, Estimated life expectancy >5 years, Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)

Unfavorable intermediate risk prostate cancer by NCCN 2021 risk stratification guidelines, including Gleason Score 4+3 or ≥ 50% biopsy cores positive

Must not have

TURP or greenlight PVP within 6 months of enrollment

Prior treatment for prostate cancer including chemotherapy, surgery, or hormonal therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a treatment called SBRT is effective for treating prostate cancer in patients who have an unfavorable intermediate-risk. The researchers will also look at whether the Decipher test can help predict which patients will benefit from more extensive radiation treatment.

Who is the study for?

This trial is for adults with unfavorable intermediate-risk prostate cancer who haven't had prior treatments like chemo, surgery, or hormonal therapy. They should have a life expectancy over 5 years and be able to undergo MRI scans. People can't join if they've had pelvic radiation before, evidence of cancer spread, recent TURP procedures, active second malignancy within the last 2 years (with some exceptions), or a history of Crohn's Disease or Ulcerative Colitis.

What is being tested?

The study tests if SBRT alone is effective in treating people with certain types of prostate cancer by preventing its return or spread without using ADT. It also evaluates the use of Decipher test results to decide on more extensive radiation treatments.

What are the potential side effects?

Potential side effects from SBRT may include urinary issues such as increased frequency and urgency, bowel changes like diarrhea, fatigue during treatment period, skin reactions in treated area and erectile dysfunction.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer is at an intermediate risk level, with a high Gleason Score or many positive biopsy results.

Exclusion Criteria

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

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I have had prostate surgery within the last 6 months.

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I have had treatment for prostate cancer, including chemotherapy, surgery, or hormone therapy.

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I have had radiation therapy to my pelvic area before.

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My MRI shows a high chance of advanced prostate cancer.

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I have a history of Crohn's Disease or Ulcerative Colitis.

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My cancer has spread to distant parts of my body, confirmed by scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Rate of biochemical progression free survival

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

2Treatment groups

Experimental Treatment

Group I: Patients with low-intermediate risk Decipher scoresExperimental Treatment1 Intervention

Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions).

Group II: Patients with high risk Decipher scoresExperimental Treatment1 Intervention

Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions) with a boost of up to 45Gy to the dominant intraprostatic lesion as identified on pretreatment MRI plus hypofractionated pelvic EBRT (25Gy in 5 fractions).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy (SBRT)

2018

Completed Phase 2

~950

0 / 8Eligibility criteria met