NCT05665738 Two-fraction HDR Monotherapy for Localized Prostate Cancer
| NCT ID | NCT05665738 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Prostate Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 17 participants |
| Start Date | 2024-09-11 |
| Primary Completion | 2029-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 17 participants in total. It began in 2024-09-11 with a primary completion date of 2029-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma. 2. National Comprehensive Cancer Network low to intermediate risk stratification. 3. No prior treatment for prostate cancer and no prior androgen deprivation therapy. 4. Age \>=18 years. 5. Eastern Cooperative Oncology Group (ECOG) performance status \<2 (Karnofsky \>60%. 6. Eligible to undergo High dose rate (HDR) brachytherapy as monotherapy as determined by the treating radiation oncologist. 7. Ability to understand and the willingness to sign a written informed consent document. 8. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. 9. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 10. 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. 11. 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: 1. Any prior treatment for prostate cancer. 2. Any prior androgen deprivation therapy. 3. Is currently receiving any other investigational agents. 4. Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure. 5. Contraindications to general anesthesia. 6. Contraindications to radiotherapy. 7. Prior cryosurgery or cryotherapy to the prostate. 8. Prior transurethral resection of the prostate within the previous 6 months.
Contact & Investigator
I-Chow Hsu, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT05665738 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05665738 currently recruiting?
Yes, NCT05665738 is actively recruiting participants. Contact the research team at Imani.Dunn@ucsf.edu for enrollment information.
Where is the NCT05665738 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT05665738 clinical trial?
NCT05665738 is sponsored by University of California, San Francisco. The principal investigator is I-Chow Hsu, MD at University of California, San Francisco. The trial plans to enroll 17 participants.