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Radiation

SBRT for Prostate Cancer

Phase 2
Recruiting
Led By Daniel Gorovets, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.

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.Check my eligibility
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.See study design
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
Select...
My prostate cancer is at an intermediate risk level, with a high Gleason Score or many positive biopsy results.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
9%
Hand-Foot
3%
Bleeding
3%
Stroke
3%
Abdominal Infection
3%
Ileus
3%
Mucositis
3%
Edema
3%
Dermatitis
3%
Platelet count decreased ( Thrombocytopenia)
100%
80%
60%
40%
20%
0%
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
~740

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,920 Previous Clinical Trials
590,388 Total Patients Enrolled
131 Trials studying Prostate Cancer
65,689 Patients Enrolled for Prostate Cancer
Daniel Gorovets, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
146 Total Patients Enrolled
3 Trials studying Prostate Cancer
146 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

Media Library

Stereotactic Body Radiation Therapy (SBRT) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05169970 — Phase 2
Prostate Cancer Research Study Groups: Patients with low-intermediate risk Decipher scores, Patients with high risk Decipher scores
Prostate Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy (SBRT) Highlights & Side Effects. Trial Name: NCT05169970 — Phase 2
Stereotactic Body Radiation Therapy (SBRT) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05169970 — Phase 2

Frequently Asked Questions

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

How wide-reaching is the scope of this trial?

"At the moment, 7 different sites are allowing enrolment into this trial. These locations include Uniondale, Middletown and Commack as well as other cities in close proximity. To reduce travel strain on participants it is important to select a site that is closest to your residence."

Answered by AI

Are there still openings for enrolment in this experiment?

"Correct. Clinicaltrials.gov confirms that the recruitment for this medical trial, first posted on December 9th 2021 is ongoing. The study requires 145 patients to be recruited from 7 participating sites around the globe."

Answered by AI

What potential risks have been identified for those receiving Stereotactic Body Radiation Therapy (SBRT)?

"Given the Phase 2 status of this clinical trial, there is evidence that suggests SBRT's safety. Consequently, it has been given a rating of 2 on Power’s scale."

Answered by AI

How many participants are currently participating in this clinical investigation?

"Affirmative. The clinicaltrials.gov website reveals that this research is currently seeking participants with the initial posting date of December 9th, 2021 and most recent update being February 23rd, 2022. In total, 145 individuals are required to be recruited from 7 medical centres across the nation."

Answered by AI
~55 spots leftby Dec 2024