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

  • Recruiting
  • Treatment
  • Interventional
  • Non Randomized
  • Radiation
  • PHASE1/PHASE2
  • Washington University School of Medicine
  • 18 Years -


Study Purpose

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.

Intervention

Radiation : HDR brachytherapy


Eligibility Requirements

info icon Histologically or cytologically confirmed diagnosis of early stage prostate cancer.

info icon 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).

info icon 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.

info icon At least 18 years of age.

info icon ECOG performance status ≤ 2

info icon Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

info icon Prior radiation therapy to the prostate or lower pelvis encompassing the prostate.

info icon 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.

info icon Currently receiving any other investigational agents.

info icon Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.

info icon Unable to undergo general, spinal or local anesthesia.

info icon Prior TURP with a sufficiently large defect that would compromise the integrity of the implant per clinician's assessment.

Recruiting status

Recruiting

Estimated enrollment

30

 
Study start date

Feb 27, 2018

Study end date

Feb 28, 2029

Last updated

Mar 22, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Radiation

Study phase

PHASE1/PHASE2

Allocation

Non Randomized

 

Sponsor:

Washington University School of Medicine

Collaborator:

N/A

Investigator:

Hiram A Gay, M.D.

NCT03424850

Clinic Location Investigator Distance RECRUITING STATUS Contact