Evaluating different doses of HDR brachytherapy for early stage prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and efficacy of high dose rate (HDR) brachytherapy at varying doses of 21 Gy, 23 Gy, and 25 Gy for patients with early stage prostate cancer. The study will monitor both early and late side effects associated with the treatment, providing valuable data on patient outcomes. Participants will be closely observed to determine the effectiveness of these different radiation doses in managing prostate cancer. The trial includes patients who are low-risk or favorable intermediate-risk based on specific clinical criteria.

Why it matters

Who can join: the full rules

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.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Hiram A Gay, M.D. — Washington University School of Medicine
• Study coordinator: Hiram A Gay, M.D.
• Email: hiramgay@wustl.edu
• Phone: 314-362-8516

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.