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MRI-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost for Prostate Cancer (SIBRT)

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ClinicalTrials.gov Identifier: NCT03664193
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
Prostate SBRT is a standard of care treatment for prostate cancer that has not spread to distant metastatic sites. Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity. In this initial study, MRI guided treatment planning and delivery will be used to deliver 7 Gy to the entire prostate and seminal vesicles, with a selective boost of additional 0.5, 1.0, 1.5 or 2 Gy per fraction for total dose of 37.5, 40, 42.5 or 45 Gy to biopsy proven lesions, defined using MRI.

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

Detailed Description:

Prostate SBRT is a standard of care treatment for prostate cancer that has not spread to distant metastatic sites. Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity. In this initial study, MRI guided treatment planning and delivery will be used to deliver 7 Gy to the entire prostate and seminal vesicles, with a selective boost of additional 0.5, 1.0, 1.5 or 2 Gy per fraction for total dose of 37.5, 40, 42.5 or 45 Gy to biopsy proven lesions, defined using MRI.

Hypothesis: MRI-guided treatment planning and delivery can selectively target high-risk prostate nodules and deliver a higher radiation dose, to achieve maximal local control without increasing treatment toxicity


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Male patients with a histologically confirmed diagnosis of non-metastatic prostate adenocarcinoma, meeting the inclusion and exclusion criteria below, and electing to undergo definitive radiation treatment with SBRT, will be eligible for participation in this study. Patients will receive 35 Gy in five fractions, in addition, patients will receive a simultaneous integrated boost from 0.5-2 Gy per fx for total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. Gastrointestinal/genitourinary toxicities will be assessed at every visit, including quality of life questionnaires and EPIC scores will be assessed at the one month follow up visits.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MRI-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost for Prostate Cancer
Actual Study Start Date : August 24, 2018
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Single Arm
Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.
Radiation: SIBRT
Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.




Primary Outcome Measures :
  1. Feasibility of delivering stereotactic body radiotherapy(SBRT) with simultaneous integrated boost(SIB) without acute GU/GI toxicities will be assessed. [ Time Frame: 2 months ]
    Feasibility of delivering stereotactic body radiotherapy(SBRT) with simultaneous integrated boost(SIB) without acute GU/GI toxicities will be assessed. the investigators will track the number of treatment plans for each dose level (37.5, 40, 42.5 or 45 Gy) that can be delivered while meeting radiation planning objectives.

  2. Safety of delivering stereotactic body radiotherapy(SBRT) with simultaneous integrated boost (SIB) without acute GU/GI toxicities will be assessed. [ Time Frame: 2 months ]
    Safety of delivering stereotactic body radiotherapy(SBRT) with simultaneous integrated boost(SIB) without acute GU/GI toxicities will be assessed. The investigators will track the number of treatment plans for each dose level (37.5, 40, 42.5 or 45 Gy) that can be delivered while meeting radiation planning objectives.


Secondary Outcome Measures :
  1. Expanded Prostate Cancer Index Composite (EPIC) quality of life questionnaires will be assessed in patients at baseline and at one month follow up. [ Time Frame: baseline, 1 month ]
    Health-related quality of life (HRQOL) measured using the Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire.

  2. American Urological Association (AUA) questionnaire will be assessed. [ Time Frame: baseline, 1 month ]
    Health-related quality of life (HRQOL) measured using the AUA assessment will occur at baseline, and at first follow up.

  3. Sexual Health Inventory for Men (SHIM) questionnaire will be assessed. [ Time Frame: baseline, 1 month ]
    Health-related quality of life (HRQOL) measured using the Sexual Health Inventory for Men (SHIM) assessment will occur at baseline, and at first follow up.



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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:   Men with a histologically confirmed diagnosis of non-metastatic prostate adenocarcinoma, meeting the inclusion and exclusion criteria below, and electing to undergo definitive radiation treatment with SBRT, will be eligible for participation in this study.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Biopsy-proven diagnosis of prostate adenocarcinoma
  2. NCCN defined low-, intermediate- and high-risk prostate cancer
  3. Age ≥ 18
  4. Patient must have prostate MRI with a PIRADS 3-5 lesion or PSMA PET with an avid intraprostatic lesion

Exclusion Criteria:

  1. History of prior pelvic radiation (external beam or brachytherapy)
  2. Inability to undergo MRI
  3. Patients with metastatic disease (other than pelvic lymph nodes) are ineligible for this study
  4. AUA score >17 - AUA score >17

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): NCT03664193


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: Josephine Kang, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Josephine Kang, M.D. Weill Cornell Medicine - New York Presbyterian Hospital

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03664193     History of Changes
Other Study ID Numbers: 1802019010
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: 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