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HDR Brachytherapy for Early Stage Prostate Cancer

This study is looking at different doses of high dose rate (HDR) brachytherapy to treat early stage prostate cancer. HDR brachytherapy is a type of radiation therapy where a radioactive source is temporarily placed inside the prostate. Researchers want to understand the results and side effects of using 21 Gy, 23 Gy, or 25 Gy doses of this treatment. You might be able to join if you are a man aged 18 or older with early stage prostate cancer that is considered low-risk or favorable intermediate-risk. The main goal is to see how well the treatment controls the cancer, specifically by measuring "biochemical control" (how well the treatment reduces certain markers in your blood) for up to three years after the treatment.

Study design
This is an interventional study with a planned enrollment of 36 participants, exploring different doses of HDR brachytherapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants to measure biochemical control for up to three years after the HDR implant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03424850

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Washington University School of Medicine
~36 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:HDR brachytherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biochemical control experienced by patients with prostate cancer treated with an HDR implant
Measured over Through 3 years after implant

Conditions

Prostate Cancer
Prostate Neoplasm

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Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Hiram A Gay, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Hiram A Gay, M.D.
[email protected]
314-362-8516
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Biochemical control experienced by patients with prostate cancer treated with an HDR implantThrough 3 years after 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