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Radiation Therapy

SBRT for Prostate Cancer (PREPARE SBRT Trial)

Phase 1
Waitlist Available
Led By Himanshu Nagar, M.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
KPS greater than equal to 70
Men aged greater than equal to18 with histologically confirmed primary prostate cancer.
Must not have
Patient with active inflammatory bowel disease defined as currently receiving therapy for IBD.
Prior history of receiving pelvic radiotherapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

This trial is for men with prostate cancer who have a Gleason Score of 8 or greater, or who have clinical or radiographic evidence of T3 disease.

Who is the study for?
The PREPARE SBRT trial is for men over 18 with high-risk prostate cancer, confirmed by a Gleason Score of 8+ or evidence of advanced disease (T3). Participants must be fit for surgery, have no prior pelvic radiotherapy, and not currently treated for inflammatory bowel disease. They need to have clear bone scans and MRI/CT scans without significant nodal involvement.
What is being tested?
This study tests the effects of increasing doses of stereotactic body radiotherapy (SBRT) before prostate removal surgery in men with aggressive prostate cancer. The goal is to see if higher radiation doses can better control the cancer when given before surgery.
What are the potential side effects?
While specific side effects are not listed here, generally SBRT may cause urinary issues, bowel problems, fatigue, skin reactions in the treatment area, and erectile dysfunction. Side effects vary based on individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mostly able to care for myself and carry out daily activities.
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I am a man over 18 with confirmed prostate cancer.
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My prostate cancer is aggressive or has spread beyond the prostate.
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My pelvic CT or MRI shows no signs of cancer spread to lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently being treated for inflammatory bowel disease.
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I have had radiation therapy to my pelvic area before.
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I do not want to have surgery to remove my prostate.

Timeline

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
Number of subjects who successfully complete radical prostatectomy after SBRT without a post-operative DLT of grade 3 or higher
Secondary study objectives
Acute Coryza
Quality of life scores in patients after stereotactic body radiotherapy (SBRT) and radical prostatectomy (RP) will be collected.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
This is a modified dose escalation and de-escalation study with an expansion of 3 or 6 pts to allow the recommended phase II dose (RP2D) be examined in a total of 9 pts. The dose limiting toxicity (DLT) is defined as Grade 3 or higher toxicity related to preoperative radiotherapy according to the Clavien-Dindo Classification. 3 radiation dose levels, 5 Gy, 6 Gy and 6.5Gy are considered. At the start of each dose level, 3 pts will be enrolled and treated for five days. If none of the 3 pts develop the DLT, the testing dose will escalate to the next level. If 1 of the 3 pts develops the DLT, the current dose will be tested in an additional 3 pts. If no additional pts develop the DLT, the dose will escalate.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dose escalation
2020
Completed Phase 3
~30

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,077 Previous Clinical Trials
1,320,632 Total Patients Enrolled
49 Trials studying Prostate Cancer
34,634 Patients Enrolled for Prostate Cancer
Himanshu Nagar, M.D.Principal InvestigatorWeill Cornell Medicine - New York Presbyterian Hospital
6 Previous Clinical Trials
482 Total Patients Enrolled
3 Trials studying Prostate Cancer
470 Patients Enrolled for Prostate Cancer

Media Library

Dose escalation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03663218 — Phase 1
Dose escalation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03663218 — Phase 1
~1 spots leftby Dec 2024
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