Recruiting
Phase 1
Phase 2

HDR Prostate Brachytherapy

Sponsor:

Washington University School of Medicine

Code:

NCT03424850

Conditions

Prostate Cancer

Prostate Neoplasm

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HDR brachytherapy

Study Details

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.

Conditions

Prostate Cancer

Prostate Neoplasm

Study ID

NCT03424850

Start date

Feb 27, 2018

Status verified date

Mar, 2026

Completion date

Feb 28, 2030

Anticipated

Primary completion date

Feb 28, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

HDR 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%

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 and Locations

Central contacts

Hiram A Gay, M.D.

314-362-8516hiramgay@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Hiram A Gay, M.D.

314-362-8516hiramgay@wustl.edu

Principal Investigator:

Hiram A Gay, M.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-03-11.