High dose rate brachytherapy for localized prostate cancer
Two-fraction High Dose Rate Brachytherapy as Monotherapy Delivered Three Hours Apart in Localized Prostate Cancer: A Pilot Study
NA · University of California, San Francisco · NCT05665738
This study is testing a new way to give high dose rate brachytherapy to treat localized prostate cancer in two sessions to see if it's safe for patients with low to intermediate risk.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 17 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of California, San Francisco (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05665738 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult males aged 18 and older with histologically confirmed low to intermediate risk prostate adenocarcinoma who have not received prior treatment.
Not a fit: Patients with high-risk prostate cancer or those who have previously undergone treatment for prostate cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more efficient and effective option for patients with localized prostate cancer.
How similar studies have performed: Previous studies have established HDR brachytherapy as safe and effective, but this specific approach of administering two fractions three hours apart is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Francisco, California
- 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: Jamese Johnson
- Email: Jamese.Johnson@ucsf.edu
- Phone: 415-530-9805
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Adenocarcinoma, Localized Prostate Carcinoma, Brachytherapy, Radiotherapy, High Dose Rate