High dose rate brachytherapy for localized prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study investigates the safety of delivering high dose rate (HDR) brachytherapy as monotherapy in two fractions, administered three hours apart, for patients with low to intermediate risk localized prostate cancer. The study aims to evaluate the safety and prostate specific antigen (PSA) kinetics associated with this treatment regimen. Participants will receive treatment on an outpatient basis and will be followed for six months post-treatment, with additional follow-ups as per standard guidelines. This approach could streamline treatment logistics and reduce resource utilization in brachytherapy departments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
2. National Comprehensive Cancer Network favorable intermediate risk stratification, defined as one or more intermediate risk factors such as cT2b - cT2c category, grade group 1 or 2, or PSA 10-20 ng/mL, and less than 50% of biopsy cores positive for carcinoma (i.e. for this trial, we will only include systematic biopsy cores, not targeted biopsy cores).
3. Age \>=18 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status \<2 (Karnofsky \>60%).
5. Eligible to undergo High dose rate (HDR) brachytherapy as monotherapy as determined by the treating radiation oncologist.
6. Ability to understand and the willingness to sign a written informed consent document.
7. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
8. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
9. 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.
10. 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.
11. Willingness and ability to complete International Prostate Symptom Score questionnaires.

Exclusion Criteria:

1. Any prior treatment for prostate cancer.
2. Prior history of pelvic malignancy.
3. Any prior androgen deprivation therapy.
4. Is currently receiving any other investigational agents.
5. Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure.
6. Contraindications to general anesthesia.
7. Contraindications to radiotherapy.
8. Prior history of pelvic radiotherapy.
9. Presence of lymph node or distant metastases.
10. Prior cryosurgery or cryotherapy to the prostate.
11. Prior transurethral resection of the prostate (TURP) or transurethral incision within the previous 6 months.
12. Estimated prostate volume \>60 cubic centimeters as determined by transrectal ultrasound or magnetic resonance imaging.
13. IPSS score of 15 or higher prior to treatment.

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: I-Chow Hsu, MD — University of California, San Francisco
• Study coordinator: Imani Dunn
• Email: Imani.Dunn@ucsf.edu
• Phone: 877-827-3222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.