Two-fraction HDR Monotherapy for Localized Prostate Cancer
Two-fraction High Dose Rate Brachytherapy as Monotherapy Delivered Three Hours Apart in Localized Prostate Cancer: A Pilot Study
University of California, San Francisco
17 participants
Sep 11, 2024
INTERVENTIONAL
Conditions
Summary
This is a single center single arm prospective pilot study investigating the safety of high dose rate (HDR) brachytherapy as monotherapy delivered in 2 fractions 3 hours apart. HDR monotherapy has been established as safe and effective in this context, however previous studies have delivered 2 fractions on separate days, or at least 6 hours apart. Clinically, this regimen, if shown to be safe and effective in future studies, has the potential to reduce operative resources and logistical stresses on brachytherapy departments.
Eligibility
Inclusion Criteria11
- Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
- National Comprehensive Cancer Network low to intermediate risk stratification.
- No prior treatment for prostate cancer and no prior androgen deprivation therapy.
- Age \>=18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status \<2 (Karnofsky \>60%.
- Eligible to undergo High dose rate (HDR) brachytherapy as monotherapy as determined by the treating radiation oncologist.
- Ability to understand and the willingness to sign a written informed consent document.
- Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Exclusion Criteria8
- Any prior treatment for prostate cancer.
- Any prior androgen deprivation therapy.
- Is currently receiving any other investigational agents.
- Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure.
- Contraindications to general anesthesia.
- Contraindications to radiotherapy.
- Prior cryosurgery or cryotherapy to the prostate.
- Prior transurethral resection of the prostate within the previous 6 months.
Interventions
High dose rate brachytherapy delivered in 13.5 Gy x 2 fractions over a single implant procedure 3 hours apart
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05665738