Two-fraction HDR Monotherapy for Localized Prostate Cancer

Description

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

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Study Overview

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Study Details

Study overview

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.

Two-fraction High Dose Rate Brachytherapy as Monotherapy Delivered Three Hours Apart in Localized Prostate Cancer: A Pilot Study

Two-fraction HDR Monotherapy for Localized Prostate Cancer

Condition
Prostate Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Francisco,

I-Chow Hsu, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2026-02-28