Condition: Prostate Adenocarcinoma, Localized Prostate Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05665738

Sponsor: University of California, San Francisco

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

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.

View trial on ClinicalTrials.gov