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Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02163317
Recruitment Status : Recruiting
First Posted : June 13, 2014
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:
This pilot clinical trial studies magnetic resonance (MRI)-guided focal stereotactic radiosurgery (SRS) in treating patients with low- or intermediate-risk localized prostate cancer. Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Radiation: stereotactic radiosurgery Device: magnetic resonance imaging Other: quality-of-life assessment Procedure: Serum Prostate Antigen Test Procedure: Digital Rectal Exam Behavioral: Expanded Prostate Cancer Index Composite Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Evaluate the correlation of histopathology findings in comparison to regions of the prostate reported to be suspicious for harboring tumor burden on multiparametric MRI report/s.

II. Demonstration of the dosimetric and radiobiological advantages of focal stereotactic body radiation therapy (SBRT) versus whole-gland radiation therapy.

III. Evaluation of clinical outcomes in focal SBRT for localized prostate cancer.

OUTLINE:

Patients undergo 3 fractions of MRI-guided focal SRS every other day for 1 week. Patients undergo additional MRI scans between the 2nd and 3rd fractionated treatments, at 6 months following the end of radiation therapy, and at 12 and 24 months.

After completion of study treatment, patients are followed up every 3 months for up to 24 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer
Actual Study Start Date : February 3, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Treatment (MRI-guided focal SRS)
Patients undergo 3 fractions of MRI-guided focal SRS every other day for 1 week. Patients undergo additional MRI scans between the 2nd and 3rd fractionated treatments, at 6 months following the end of radiation therapy, and at 12 and 24 months.
Radiation: stereotactic radiosurgery
Undergo MRI-guided focal SRS

Device: magnetic resonance imaging
Undergo staging MRI with contrast
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging

Other: quality-of-life assessment
Quality of life scores will be summarized graphically and repeated measures of variance will be conducted to test for changes in scores over time
Other Names:
  • quality of life assessment
  • International Prostate Symptom Score / Sexual Health Inventory for Men (IPSS/SHIM) QoL Scores
  • Health related quality of life (HRQOL)

Procedure: Serum Prostate Antigen Test
Test of the PSA protein in blood. The test will be run every three months for up to two years during the study.
Other Names:
  • PSA
  • PSA response

Procedure: Digital Rectal Exam
Exam of rectal health. Performed every three months for up to two years throughout the study.
Other Name: DRE

Behavioral: Expanded Prostate Cancer Index Composite
This survey measures a patient's function and bother after prostate cancer treatment. It will be analyzed using ANOVA using data collected every 6 months for up to 2 years of the study.
Other Name: EPIC




Primary Outcome Measures :
  1. Number of patients with change in EPIC bowel domain score that was worse than 5 points [ Time Frame: Up to 1 year from start of study ]
  2. Number of patients with change in EPIC urinary domain score that was worse than 2 points [ Time Frame: Up to 1 year from start of study ]

Secondary Outcome Measures :
  1. PSA response [ Time Frame: Up to 2 years from start of study ]
    Number of patients with PSA failure. Failure occurs when the PSA is first noted to be 2 ng/mL or more than the patient's nadir value post radiation therapy completion

  2. Number of acute gastrointestinal (GI) grade 3+ acute adverse events, evaluated by the Cancer Therapy Evaluation Program (CTEP) active version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 30 days after the completion of radiation therapy ]
    Defined as the first occurrence of worst severity of the adverse event =< 30 days after the completion of radiation therapy. Multivariate analysis will be used, and acute rates of GI toxicity will be reported with dose-volume histogram.

  3. Number of acute genitourinary (GU) grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE [ Time Frame: Up to 2 years from start of study ]
    Defined as the first occurrence of worst severity of the adverse event =< 30 days after the completion of radiation therapy.

  4. Number of late GI grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE [ Time Frame: Up to 2 years from start of study ]
    Defined as the first occurrence of worst severity of adverse event > 180 days after radiation therapy completion. Multivariate analysis will be used, and acute rates of GI toxicity will be reported with dose-volume histogram.

  5. Number of late GU grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE [ Time Frame: Up to 2 years from start of study ]
    Defined as the first occurrence of worst severity of adverse event > 180 days after radiation therapy completion.

  6. Number of patients with Disease-free survival [ Time Frame: Up to 2 years from start of study ]
    Defined as From the date of treatment to the date of documentation of disease progression or until the date of death from any cause. Radiographic efficacy will be summarized by calculating Kaplan-Meier curves. Also, 95% confidence intervals will be reported. Descriptive reports of Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) and volumetric findings will be provided.

  7. Time to local progression [ Time Frame: Up to 2 years from start of study ]
    Radiographic efficacy will be summarized by calculating Kaplan-Meier curves. Descriptive reports of RECIST (1.1) and volumetric findings will be provided. Time will be reported in months.

  8. Time to distant failure [ Time Frame: Up to 2 years from start of study ]
    Radiographic efficacy will be summarized by calculating Kaplan-Meier curves. Descriptive reports of RECIST (1.1) and volumetric findings will be provided. Time will be reported in 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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a histologically confirmed diagnosis of adenocarcinoma of the prostate
  • Patient must have a history/physical examination with digital rectal examination of the prostate within 90 days prior to screening
  • Eastern Cooperative Oncology Group (ECOG) performance status must be level 0 or 1 within 60 days prior to registration
  • Patient must have a histological evaluation of the prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores ≤ 7(3+4)
  • Serum creatinine ≤ 1.5 times upper limit of institutional normal (normal: ≤ 1.17 mL/min/1.73 m^2)
  • Clinical stage a ≤ T1-T2a (American Joint Committee on Cancer [AJCC] 7th edition)
  • Prostate specific antigen (PSA) ≤ 10 ng/mL within 90 days prior to registration; PSA should not be obtained within 10 days after prostate biopsy
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document
  • Patient willing and able to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire (baseline, 6, 12 and 24 months post end of radiation therapy)
  • Patients must be able to undergo an MRI with contrast
  • Bone scan completed within 90 days

Exclusion Criteria:

  • Evidence of distant metastases
  • Regional lymph node involvement
  • Previous radical surgery (prostatectomy), cryosurgery, or high intensity focused ultrasound (HIFU) for prostate cancer
  • Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  • Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol [DES]), or surgical castration (orchiectomy)
  • Use of finasteride within 30 days prior to registration; PSA should not be obtained prior to 30 days after stopping finasteride
  • Use of dutasteride within 90 days prior to registration; PSA should not be obtained prior to 90 days after stopping dutasteride
  • Previous or concurrent cytotoxic chemotherapy for prostate cancer
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol; (patients on Coumadin or other blood thinning agents are eligible for this study)
  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease and Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients
  • Patients unable to undergo an MRI with contrast

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): NCT02163317


Contacts
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Contact: Bryan Traughber, MD 216-844-3061 bryan.traughber@uhhospitals.org

Locations
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United States, Ohio
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Bryan Traughber, MD    216-844-3061    Bryan.Traughber@uhhospitals.org   
Principal Investigator: Bryan Traughber, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Bryan Traughber, MD Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02163317     History of Changes
Other Study ID Numbers: CASE11813
NCI-2014-01170 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE11813
CASE 11813 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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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
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
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Genital Diseases, Male
Carcinoma