Two-fraction HDR Monotherapy for Localized Prostate Cancer
Recruiting · NCT05665738 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, San Francisco
View the official record on ClinicalTrials.gov →Interventions studied
High Dose Rate Monotherapy
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed across 1 US state.
- University of California, San Francisco - San Francisco, California, United States