Recruiting

HDR Monotherapy

Sponsor:

UCLA

Code:

NCT05665738

Conditions

Prostate Adenocarcinoma

Localized Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High Dose Rate Monotherapy

Study Details

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.

Conditions

Prostate Adenocarcinoma

Localized Prostate Carcinoma

Study ID

NCT05665738

Start date

Sep 11, 2024

Status verified date

Jun, 2026

Completion date

Feb 28, 2029

Anticipated

Primary completion date

Feb 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

17 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HDR brachytherapy

Participants will receive the same radiotherapy technique, methods, and delivery will as standard of care 3 hours apart instead of receiving the radiotherapy on separate days.

Interventions

High Dose Rate Monotherapy

High dose rate brachytherapy delivered in 13.5 Gy x 2 fractions over a single implant procedure 3 hours apart

Primary outcome measure

  • Proportion of participants with treatment-related adverse events [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Imani Dunn

877-827-3222Imani.Dunn@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Imani Dunn

877-827-3222Imani.Dunn@ucsf.edu

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

I-Chow Hsu, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • Brachytherapy
  • Radiotherapy
  • High Dose Rate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-06-05.