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Recruiting Phase 1, Phase 2 NCT03424850

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

Trial Parameters

Condition Prostate Cancer
Sponsor Washington University School of Medicine
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 36
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2018-02-27
Completion 2030-02-28
Interventions
HDR brachytherapy

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.

Eligibility 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 previ

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