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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dose escalation
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Weill Cornell MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of subjects who successfully complete radical prostatectomy after SBRT without a post-operative DLT of grade 3 or higher
Successful completion of radical prostatectomy after SBRT without a post-operative DLT of grade 3 or higher within 30 days after prostatectomy.

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2018
Last Updated
April 18, 2023
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT03663218
Brief Title
PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)
Acronym
PREPARE SBRT
Official Title
PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Men with prostate cancer with Gleason Score of 8 or greater or clinical/radiographic evidence of T3 disease will be considered for this trial.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Dose escalation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of subjects who successfully complete radical prostatectomy after SBRT without a post-operative DLT of grade 3 or higher
Description
Successful completion of radical prostatectomy after SBRT without a post-operative DLT of grade 3 or higher within 30 days after prostatectomy.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
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.
Description
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
Title
Quality of life scores in patients after stereotactic body radiotherapy (SBRT) and radical prostatectomy (RP) will be collected.
Description
Quality of life scores in patients after stereotactic body radiotherapy (SBRT) and radical prostatectomy (RP) will be collected.
Time Frame
5 years

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male patients with a diagnosis of high risk prostate cancer who meet the inclusion and exclusion criteria will be eligible for participation in this study.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharanya Chandrasekhar, M.S.
Phone
646-962-2196
Email
shc2043@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Pragya Yadav, Ph.D.
Phone
646-962-2199
Email
pry2003@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Himanshu Nagar, M.D.
Organizational Affiliation
Weill Cornell Medicine - New York Presbyterian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Ekeh, M.D.
Phone
646-962-2196
Email
che4005@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Pragya Yadav, Ph.D.
Phone
646-962-2199
Email
pry2003@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Himanshu Nagar, M.D.
First Name & Middle Initial & Last Name & Degree
Christopher Barbieri, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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