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MRI Guided SBRT for Localized Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03778112
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:

This study utilizes advanced imaging techniques (mpMRI prostate scan) to select and stratify patients for two different radiotherapy regimens based on the presence/absence of identifiable intraprostatic lesions.

In patients without identifiable prostate cancer lesions, SBRT to the prostate in 5 sessions (fractions) will be administered.

In patients with MRI-identified lesion(s), pelvic IMRT in 25 fractions will be administered followed by an SBRT prostate boost while simultaneously treating the prostate cancer lesion(s) to a higher dose in 3 fractions.


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: SBRT to whole prostate Radiation: IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions Phase 2

Detailed Description:

Radiotherapy (RT) is considered standard of care treatment for prostate cancer. Conventional RT regimens consist of 8-9 weeks of daily RT. Recent data support the use of hypofractionated RT (5-6 weeks) due to similar disease control in a contracted treatment time. This study combines the benefits of RT dose escalation while shortening the overall RT treatment course.

In this protocol, patients will undergo a pretreatment mpMRI prostate scan and be stratified to two separate SBRT regimens depending on whether prostate lesions are present. For patients without any positive mpMRI lesions, an SBRT monotherapy (36.25 Gy in 5 fractions) approach will be utilized. Patients with an equivocal or positive mpMRI lesion(s), will receive IG-IMRT (45 Gy in 25 fractions) to prostate and seminal vesicle +/- lymph nodes followed by a SBRT whole prostate boost (18 Gy in 3 fractions) with a simultaneously integrated boost (SIB) (21 Gy in 3 fractions) to intraprostatic lesion(s) only.

Patients will be regularly assessed every 3 months for the first 2 years and then every 6 months, indefinitely. Side effects will be monitored using the standardized international prostate symptom score (I-PSS) and Sexual Health Inventory of Men (SHIM) questionnaires at baseline and subsequent follow-up appointments.

Hypothesis: MRI-guided treatment planning and delivery can selectively target high-risk prostate cancer nodules and deliver a higher effective RT dose, to achieve maximal tumor control without increasing toxicity, all in a shortened treatment duration.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Multi-Parametric MRI Guided Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer
Actual Study Start Date : May 23, 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Negative mpMRI Prostate Scan
SBRT to the whole prostate
Radiation: SBRT to whole prostate
Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate

Experimental: Positive mpMRI Prostate Scan
IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions
Radiation: IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions
Patients with positive or equivocal mpMRI prostate scan (PI-RADS 3-5) will receive IMRT (45 Gy/25 fractions) to the prostate + seminal vesicles +/- lymph nodes followed by SBRT boost (18 Gy/3 fractions) to the whole prostate with simultaneous integrated boost (21 Gy/3 fractions) to MRI defined intraprostatic lesions




Primary Outcome Measures :
  1. Rate of Late Radiation Induced Genitourinary and Gastrointestinal Toxicity [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Rate of Acute Radiation Induced Genitourinary Toxicity [ Time Frame: 3 months ]
  2. Biochemical Recurrence [ Time Frame: 18 months ]
  3. Disease Free-Survival [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven prostate adenocarcinoma within 1 year of randomization
  • NCCN Low to High Risk localized prostate cancer
  • Zubrod Performance Status 0-1 within 60 days prior to registration

Exclusion Criteria:

  • Prior or concurrent invasive malignancy (except non-melanoma skin cancer)
  • Regional Lymph Node (N1) involvement
  • Distant Metastases (M1) involvement
  • History of prior pelvic irradiation (external beam radiotherapy or brachytherapy)
  • Prior chemotherapy
  • Severe, active co-morbidities (unstable angina and/or CHF; MI; COPD; liver disease; AIDS)
  • Acute bacterial or fungal infection requiring IV antibiotics
  • Inability to undergo MRI
  • Inability to receive fiducial markers

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): NCT03778112


Contacts
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Contact: Robert Stines, RN 312-563-0789 robert_stines@rush.edu
Contact: Riley J Sticca, BS, CCRP 312-563-5769

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Dian Wang, MD, PhD    312-942-5751    dian_wang@rush.edu   
Contact: Mudit Chowdhary, MD    312-942-1210    mchowdharymd@gmail.com   
Principal Investigator: Dian Wang, MD, PhD         
Sub-Investigator: Mudit Chowdhary, MD         
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Dian Wang, MD, PhD Rush University Medical Center

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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03778112     History of Changes
Other Study ID Numbers: 15060207
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Rush University Medical Center:
Prostate Cancer
Radiotherapy
SBRT
Stereotactic Body Radiotherapy
MRI
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases