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

March 22, 2024 updated by: Weill Medical College of Cornell University
Men with prostate cancer with Gleason Score of 8 or greater or clinical/radiographic evidence of T3 disease will be considered for this trial.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with a diagnosis of high risk prostate cancer with a Gleason score of 8 or greater are eligible for this trial. The study will enroll 20 subjects in 3 years. This is a single arm study and the primary objectives is to assess if a patient can undergo a radical prostatectomy after SBRT without a post-operative grade 3 or higher toxicity (according to Clavien-Dindo Classification) at 30 days. Secondary objectives are to assess acute toxicity and quality of life scores. Exploratory objectives will include analysis of tumor and normal biopsied and resected tissue and serum markers and interpretation of interfraction and intrafraction MRIs.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men aged greater than equal to18 with histologically confirmed primary prostate cancer.
  • KPS greater than equal to 70
  • Patient with a negative staging bone scan.
  • Patient can undergo an MRI.
  • Patient with negative staging CT or MRI of pelvis. Suspicious evidence of nodal involvement on staging CT or MRI of pelvis is defined as greater than 1 cm on short axis. Documented negative biopsy of suspicious node required.
  • Patient is medically fit to undergo prostatectomy.
  • Patient has either Gleason Score greater than equal to 8 on biopsy and/or clinical/radiographic evidence of T3 disease.

Exclusion Criteria:

  • Prior history of receiving pelvic radiotherapy.
  • Patient is unwilling to undergo prostatectomy.
  • Patient with active inflammatory bowel disease defined as currently receiving therapy for IBD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm
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.
Radiation: Dose escalation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects who successfully complete radical prostatectomy after SBRT without a post-operative DLT of grade 3 or higher
Time Frame: 1 month
Successful completion of radical prostatectomy after SBRT without a post-operative DLT of grade 3 or higher within 30 days after prostatectomy.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute toxicity in patients after stereotactic body radiotherapy (SBRT) and radical prostatectomy (RP) will be assessed based on NCI Common terminology criteria for adverse events (CTCAE) version 5.0.
Time Frame: 3 months
Acute toxicity in patients after stereotactic body radiotherapy (SBRT) and radical prostatectomy (RP) will be assessed based on NCI Common terminology criteria for adverse events (CTCAE) version 5.0.
3 months
Quality of life scores in patients after stereotactic body radiotherapy (SBRT) and radical prostatectomy (RP) will be collected.
Time Frame: 5 years
Quality of life scores in patients after stereotactic body radiotherapy (SBRT) and radical prostatectomy (RP) will be collected.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Himanshu Nagar, M.D., Weill Cornell Medicine - New York Presbyterian Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2018

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

August 30, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1712018849

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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