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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663218
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Dose escalation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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 7Gy 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 7Gy 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 Measures :
  1. Assessing if patients can undergo a radical prostatectomy after SBRT without a post-operative gastrointestinal or urinary grade 3 or above toxicity according to Clavien-Dindo Classification within 30 days related to preoperative radiotherapy. [ Time Frame: 3 months ]
    Assessing if patients can undergo a radical prostatectomy after SBRT without a post-operative gastrointestinal or urinary grade 3 or above toxicity according to Clavien-Dindo Classification within 30 days related to preoperative radiotherapy.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   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.
Accepts Healthy Volunteers:   No
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 willing to undergo placement of a rectal spacer.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663218


Contacts
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Contact: Sharanya Chandrasekhar, M.S. 646-962-2196 shc2043@med.cornell.edu
Contact: Pragya Yadav, Ph.D. 646-962-2199 pry2003@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Sharanya Chandrasekhar, M.S.    646-962-2196    shc2043@med.cornell.edu   
Contact: Pragya Yadav, Ph.D.    646-962-2199    pry2003@med.cornell.edu   
Principal Investigator: Himanshu Nagar, M.D.         
Principal Investigator: Christopher Barbieri, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Himanshu Nagar, M.D. Weill Cornell Medicine - New York Presbyterian Hospital
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03663218    
Other Study ID Numbers: 1712018849
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases