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

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Jan 31, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a treatment method called high dose rate brachytherapy for early-stage prostate cancer. The goal is to find out how effective this treatment is and what side effects patients might experience, both right after the treatment and later on. Men aged 65 to 74 who have been diagnosed with low-risk or favorable intermediate-risk prostate cancer may be eligible to participate. This includes those who have not had previous radiation therapy to the prostate and who are generally healthy enough to undergo the treatment.

If you or a loved one decides to participate, you will receive a specific dose of radiation directly to the prostate to help fight cancer. Participants will be monitored closely for any side effects and overall treatment outcomes. It’s important to know that if you have certain health issues or have had other types of cancer recently, you might not qualify for this trial. This study is currently recruiting participants, and being part of it could contribute to better understanding and improving prostate cancer treatments in the future.

Gender

MALE

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 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.