RECRUITING

Two-fraction HDR Monotherapy for Localized Prostate Cancer

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Conditions

Prostate AdenocarcinomaLocalized Prostate CarcinomaBrachytherapyRadiotherapyHigh Dose Rate

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2024-09-11
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05665738

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
  2. 2. National Comprehensive Cancer Network low to intermediate risk stratification.
  3. 3. No prior treatment for prostate cancer and no prior androgen deprivation therapy.
  4. 4. Age \>=18 years.
  5. 5. Eastern Cooperative Oncology Group (ECOG) performance status \<2 (Karnofsky \>60%.
  6. 6. Eligible to undergo High dose rate (HDR) brachytherapy as monotherapy as determined by the treating radiation oncologist.
  7. 7. Ability to understand and the willingness to sign a written informed consent document.
  8. 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. 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. 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. 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. 1. Any prior treatment for prostate cancer.
  2. 2. Any prior androgen deprivation therapy.
  3. 3. Is currently receiving any other investigational agents.
  4. 4. Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure.
  5. 5. Contraindications to general anesthesia.
  6. 6. Contraindications to radiotherapy.
  7. 7. Prior cryosurgery or cryotherapy to the prostate.
  8. 8. Prior transurethral resection of the prostate within the previous 6 months.

Contacts and Locations

Study Contact

Jamese Johnson
CONTACT
415-530-9805
Jamese.Johnson@ucsf.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, San Francisco

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-11
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2024-09-11
Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

  • Brachytherapy
  • Radiotherapy
  • High Dose Rate

Additional Relevant MeSH Terms

  • Prostate Adenocarcinoma
  • Localized Prostate Carcinoma