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Safety and Efficacy of 21 Gy for High Dose Rate (HDR) Prostate Brachytherapy

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ClinicalTrials.gov Identifier: NCT03424850
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose rate brachytherapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Neoplasm Radiation: HDR brachytherapy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study Evaluating the Safety and Efficacy of 21 Gy for High Dose Rate (HDR) Prostate Brachytherapy
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : February 27, 2026
Estimated Study Completion Date : February 27, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: HDR brachytherapy
-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 23 Gy.
Radiation: HDR brachytherapy

-Dose constraints are as follows:

  • Bladder and rectum: V65 < 1 cc
  • Urethra: V105 < 1 cc
  • V125: 0%




Primary Outcome Measures :
  1. Biochemical control experienced by patients with prostate cancer treated with an HDR implant [ Time Frame: Through 3 years after implant ]
    -Response will be determined by PSA. The Phoenix definition will be used for determining biochemical failure: a rise of 2 ng/mL or more above the PSA nadir


Secondary Outcome Measures :
  1. Rate of acute toxicity experienced by patients with prostate cancer treated with an HDR implant [ Time Frame: Through 3 years after implant ]
    -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

  2. Rate of late toxicity experienced by patients with prostate cancer treated with an HDR implant [ Time Frame: Through 3 years after implant ]
    -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.



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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:

  • Histologically or cytologically confirmed diagnosis of early stage prostate cancer.
  • Must be considered either low-risk (T1-T2a, Gleason ≤ 6, PSA < 10 ng/mL) or favorable intermediate-risk (Gleason 3 +4 = 7, percentage of positive biopsy cores < 50%, no more than one NCCN intermediate risk factor).
  • Prior androgen deprivation therapy is allowed and may have been initiated up to 6 months prior to the date of the HDR implant. The complete duration of androgen deprivation therapy can range from 4 months to 36 months provided it has been initiated no more than 6 months prior to the date of the HDR implant.
  • At least 18 years of age.
  • ECOG performance status ≤ 2
  • Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

  • Prior radiation therapy to the prostate or lower pelvis encompassing the prostate.
  • A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only.
  • Currently receiving any other investigational agents.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  • Unable to undergo general, spinal or local anesthesia.
  • Prior TURP

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): NCT03424850


Contacts
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Contact: Hiram A Gay, M.D. 314-362-8516 hiramgay@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Hiram A Gay, M.D.    314-362-8516    hiramgay@wustl.edu   
Principal Investigator: Hiram A Gay, M.D.         
Sub-Investigator: Jeff M Michalski, M.D.         
Sub-Investigator: Brian Baumann, M.D.         
Sub-Investigator: Todd DeWees, Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Hiram A Gay, M.D. Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03424850     History of Changes
Other Study ID Numbers: 201801118
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
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
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