Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Prostate Cancer+1 More
Stereotactic Body Radiation Therapy (SBRT) - Radiation
Eligibility
18+
Male
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 2 years

2 years
Rate of biochemical progression free survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Gem + Xeloda + SBRT
21%Anemia
18%Neutropenia
15%Hypoalbuminemia
15%White blood cell decreased ( leukopenia)
15%Diarrhea
12%Liver Dysfunction
9%Hand-Foot
3%Bleeding
3%Stroke
3%Abdominal Infection
3%Ileus
3%Mucositis
3%Edema
3%Dermatitis
3%Platelet count decreased ( Thrombocytopenia)
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT01360593) in the Gem + Xeloda + SBRT ARM group. Side effects include: Anemia with 21%, Neutropenia with 18%, Hypoalbuminemia with 15%, White blood cell decreased ( leukopenia) with 15%, Diarrhea with 15%.

Trial Design

2 Treatment Groups

Patients with high risk Decipher scores
1 of 2
Patients with low-intermediate risk Decipher scores
1 of 2
Experimental Treatment

145 Total Participants · 2 Treatment Groups

Primary Treatment: Stereotactic Body Radiation Therapy (SBRT) · No Placebo Group · Phase 2

Patients with high risk Decipher scores
Radiation
Experimental Group · 1 Intervention: Stereotactic Body Radiation Therapy (SBRT) · Intervention Types: Radiation
Patients with low-intermediate risk Decipher scores
Radiation
Experimental Group · 1 Intervention: Stereotactic Body Radiation Therapy (SBRT) · Intervention Types: Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy (SBRT)
2014
Completed Phase 2
~630

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,821 Previous Clinical Trials
584,202 Total Patients Enrolled
127 Trials studying Prostate Cancer
65,281 Patients Enrolled for Prostate Cancer
Michael Zelefsky, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
11 Previous Clinical Trials
827 Total Patients Enrolled
8 Trials studying Prostate Cancer
520 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have Grade Group 2 or 3.
You have a T2b-T2c lesion.
You have a PSA level of 10 to 20 ng/mL.
You have a pathologically proven diagnosis of prostate adenocarcinoma within 12 months of enrollment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: October 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.