Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT03424850
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HDR brachytherapy — RADIATION
    * Dose constraints for 21 Gy: * Bladder and rectum: V70 \< 1 cc * Urethra: V115 \< 1 cc * V135: 0% * Dose constraints for 23 Gy: * Bladder and rectum: V65 \< 1 cc * Urethra: V105 \< 1 cc * V125: 0% * Dose constraints for 25 Gy: * Prostate V100 \>90% (\>95% preferred) * Bladder and rectum: V70 \< 1 cc, Dmax \<115% * Urethra: V110 \< 1 cc, Dmax \<120%

Study Details

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.

Key Dates

Start date
Feb 27, 2018
Status verified
Mar 2026
Primary completion
Feb 28, 2030
Completion
Feb 28, 2030

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: HDR brachytherapy - 21 Gy
    -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 21 Gy.
  • Experimental: HDR brachytherapy - 23 Gy
    -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.
  • Experimental: HDR brachytherapy - 25 Gy
    -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 25 Gy.

Primary Outcome Measure

Biochemical control experienced by patients with prostate cancer treated with an HDR implant [ Time Frame: Through 3 years after implant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Hiram A Gay, M.D.
[email protected]
314-362-8516
Hiram A Gay, M.D. (PRINCIPAL_INVESTIGATOR)
Jeff M Michalski, M.D. (SUB_INVESTIGATOR)
Joshua Schiff, M.D. (SUB_INVESTIGATOR)
Trevor Zimmerman (SUB_INVESTIGATOR)
Michael Altman, Ph.D. (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Washington University School of Medicine· St Louis, MO

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