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RecruitingInterventionalPhase 1/Phase 2

A Phase I/II Dose-escalation Study Evaluating the Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy

NCT ID: NCT03424850Sponsor: Washington University School of MedicineLast updated: 2026-03-11

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.

Arms & interventions

  • RadiationHDR brachytherapy

    * 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%

Outcome measures

Primary

  • Biochemical control experienced by patients with prostate cancer treated with an HDR 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

    Time frame: Through 3 years after implant

Secondary

  • Rate of acute toxicity experienced by patients with prostate cancer treated with an HDR implant

    Time frame: From start of treatment through 90 days

  • Rate of late toxicity experienced by patients with prostate cancer treated with an HDR implant

    Time frame: From day 91 through 3 years after implant

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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 with a sufficiently large defect that would compromise the integrity of the implant per clinician's assessment.

Study locations (1)

Washington University School of Medicine

St Louis, Missouri, 63110

Recruiting
Hiram A Gay, M.D. · Contact
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