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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

PREPARE SBRT Trial 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.Check my eligibility

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.See study design

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.

PREPARE SBRT Trial 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.

PREPARE SBRT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of subjects who successfully complete radical prostatectomy after SBRT without a post-operative DLT of grade 3 or higher

Secondary outcome measures

Acute Coryza

Quality of life scores in patients after stereotactic body radiotherapy (SBRT) and radical prostatectomy (RP) will be collected.

PREPARE SBRT 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.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,610 Total Patients Enrolled

48 Trials studying Prostate Cancer

35,604 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

Frequently Asked Questions

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

May I participate in this experiment?

"This clinical trial is looking to enroll 35 individuals with prostate cancer, aged 18-90. Notably, patients must have a Karnofsky Performance Status (KPS) of at least 70 in order to qualify for the study."

Answered by AI

How many individuals are eligible to participate in this clinical experiment?

"Affirmative. The relevant clinical trial details, which were initially posted on October 24th 2018, can be found online at clinicaltrials.gov and confirm that the current recruitment drive is seeking 35 volunteers from one site."

Answered by AI

Is this experiment in progress and accepting participants?

"This investigation is recruiting participants, as indicated by the information on clinicaltrials.gov which shows that it was published on October 24th 2018 and last modified July 29th 2022."

Answered by AI

Has this remedy been given official sanction by the Food and Drug Administration?

"This novel treatment has only been tested minimally, so it received a rating of 1 for safety."

Answered by AI

Does the protocol for this investigation permit minors to participate?

"Those hoping to be accepted into this clinical trial must meet the age range of 18-90 years old. For those younger than 18, there are 76 studies available and 1,315 for seniors over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)

2018. "PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03663218.

All > Prostate Cancer New York