Phase II Trial of Focal Prostate Ablation Combined With Androgen Deprivation Therapy for Prostate Cancer Treatment
Summary
The purpose of this research is to gather information on the safety and effectiveness of combining focal prostate ablation therapy ((aka Focal Therapy, a surgical procedure) and androgen deprivation therapy (hormone therapy).
Arms & interventions
- DrugAndrogen Deprivation Therapy (ADT)
ADT will be given for 3 months. Participants will receive a standard ADT as chosen by their study doctor.
- ProcedureFocal prostate ablation (focal therapy)
Focal prostate ablation (focal therapy) is a surgical procedure to destroy cancer cells by destroying a portion of the prostate instead of the whole prostate.
Outcome measures
Primary
Number of participants with clinically significant residual prostate cancer in ablated prostate tissue following study treatment
Proportion of participants that have residual cancer in ablated prostate tissue. Residual disease will be measured by MRI.
Time frame: End of Treatment (approximately 4-5 months)
Number of participants with clinically significant residual prostate cancer in unablated prostate tissue following study treatment
Proportion of participants that have residual cancer in unablated prostate tissue. Residual disease will be measured by MRI.
Time frame: End of Treatment (approximately 4-5 months)
Number and grade of complications [Safety]
Number and grade of complications will be reported. Number and grade of complications will be reported. The number and severity by Common Terminology Criteria for Adverse Events (CTCAE) grade of reported complications will be reported.
Time frame: 6-months following treatment
Secondary
Measuring change in genitourinary and sexual function and health-related quality of life (measured by HRQoL)
Time frame: 6-and 12-months after FT
PSA response to the combination treatment
Time frame: Baseline, 3-months, 6-months, and 1-year from FT
Proportion of men converting therapy or dying of prostate cancer during study
Time frame: 12 months after FT
Post Treatment biopsy with no prostate cancer
Time frame: 6 months after FT
Proportion of men with normal baseline serum
Time frame: 6-, 9- and 12-months after FT.
Eligibility criteria
Study locations (1)
UChicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
References
- Koehler J, Lama D, Mendez M, Hsu WW, Oto A, Szmulewitz R, Sidana A. Phase II trial protocol of focal prostate ablation combined with androgen deprivation therapy for prostate cancer treatment. PLoS One. 2025 Dec 16;20(12):e0337828. doi: 10.1371/journal.pone.0337828. eCollection 2025.(PubMed)