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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

No Placebo-Only Group

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 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

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.

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 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

0 / 7Eligibility criteria met