Prostate Cancer Treatment Using Androgen Deprivation Therapy and Focal Prostate Ablation

Phase II Trial of Focal Prostate Ablation Combined With Androgen Deprivation Therapy for Prostate Cancer Treatment

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).

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Androgen Deprivation Therapy (ADT); Procedure: Focal prostate ablation (focal therapy)

• Study Type: Interventional
• Enrollment (Estimated): 57
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Cancer Intake; Phone Number: 1-855-702-8222; Email: cancerclinicaltrials@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • UChicago Medicine Comprehensive Cancer Center
      • Principal Investigator: Abhinav Sidana, MD
      • Contact: Cancer Intake; Phone Number: 855-702-8222; Email: cancerclinicaltrials@bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects must have intermediate-risk PCa as defined by the below criteria:

  a. Favorable intermediate-risk PCa: i. ≤ clinical stage T2c, GG2, and PSA ≤ 10 ng/mL, and <50% positive biopsy cores with PCa b. Unfavorable intermediate-risk PCa: i. ≤ clinical stageT2c, GG2, and PSA 10-20 ng/mL, or ≥50% positive biopsy cores with PCa, or ii. ≤ clinical stage T2c, GG3, and PSA < 20 ng/mL

• No mpMRI evidence of extra-prostatic extension (EPE) or seminal vesicle invasion, and if seminal vesical invasion is suspected, it must be excluded by prostate biopsy.
• Subjects must have chosen to get Focal Therapy for the treatment of prostate cancer.
• Subjects must have confirmed non-metastatic PCa following SOC screening for patients with unfavorable intermediate-risk PCa, a combination of computed tomography imaging of the abdomen and pelvis (CTAP) and technetium-99-mDP nuclear medicine bone scan (BS) and/or prostate-specific membrane antigen positron emission tomography (PSMA/PET) scan prior to enrollment. The imaging studies should be obtained within 6-months of enrollment. Additional imaging is not required for men with favorable intermediate-risk PCa.
• Subject must be male ≥ 18 years-old.
• Subjects must have a life expectancy of at least 10-years per the opinion of the treating investigator.
• Subjects must be designated as Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 or Karnofsky Performance Status Scale Score ≥ 60%, see Appendix A).
• Subjects must be fit to undergo general anesthesia and the FT surgical procedure, which includes adequate visualization of the prostate gland on transrectal ultrasound imaging, access to the urethra, perineum and rectum, as well as be tolerant of lithotomy positioning in the opinion of the treating investigator or the operating surgeon(s) if not the same as the treating investigator.
• Subjects must have adequate organ and marrow function as defined below:

Hemoglobin ≥ 10 g/dL Leukocytes ≥ 3,000/mcL Absolute neutrophil count ≥ 1,500/mcL Platelets ≥ 100,000/mcL Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN Creatinine < 1.5 institutional ULN OR Calculated or measured creatinine clearance > 50 mL/min/1.73 m2 eGFR >30 mL/min using the MDRD (modification of diet and renal disease) formula Serum albumin ≥3.0 g/dL Serum potassium ≥3.5 mmol/L

• Subjects 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.
• Subjects who are sexually active with a woman of childbearing potential must agree to use a condom with spermicidal foam/gel/film/cream/suppository and his partner must also be practicing a highly effective method of contraception (i.e., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system) during treatment and for 3-months following the last ADT treatment.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Subject has had prior or current PCa therapies, such as biologic, chemotherapy, hormone therapy, radiotherapy or surgery for PCa. Subjects may not have had undergone pelvic radiation, chemotherapy or immunotherapy treatment for a separate hematologic or visceral malignancy within 6-months of enrollment in the present study.
• Subjects with locally advanced, nodal or metastatic prostate cancer.
• Subjects who are unfit for pelvic mpMRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, metallic implants that are likely to contribute to significant image artifacts, allergy or contraindication to gadolinium contrast agent.
• History of allergy or intolerance to study drug components.
• History of bilateral orchiectomy.
• If the subject has an uncontrolled or major debilitating inter-current illness.
• Subjects who are receiving any other investigational agents, or who have received other investigational agents in the past and who are no longer receiving these investigational agents may be eligible at the discretion of the principal investigator (PI).
• Judgment by the treating investigator or PI that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions and requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Participants will receive Androgen deprivation therapy (ADT) followed by Focal prostate ablation (focal therapy)	Drug: Androgen Deprivation Therapy (ADT); ADT will be given for 3 months. Participants will receive a standard ADT as chosen by their study doctor.; Procedure: Focal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	6-months following treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA response to the combination treatment	Determine the PSA response to the combination treatment by measuring the subject's PSA at "baseline" (PSA at time of initial diagnosis) 3-months, 6-months, and 1-year from FT	Baseline, 3-months, 6-months, and 1-year from FT
Proportion of men converting therapy or dying of prostate cancer during study	Determine the proportion of men converting to whole gland therapy (radical prostatectomy or radiation therapy) and/or requiring systemic therapy and/or developing metastases and/or dying of PCa during the course of study.	12 months after FT
Post Treatment biopsy with no prostate cancer	Determine the proportion of men without any prostate cancer on any post treatment prostate biopsy.	6 months after FT
Proportion of men with normal baseline serum	Determine the proportion of men with normal baseline serum testosterone who had testosterone recovery (defined as testosterone levels >300 ng/dL) at 6-, 9- and 12-months after FT. Testosterone recovery: Number of men who have recovered normal serum testosterone levels will be expressed as proportions of total number of eugonadal patients and the 95% confidence interval of the proportion will be presented.	6-, 9- and 12-months after FT.
Measuring change in genitourinary and sexual function and health-related quality of life (measured by HRQoL)	Define change in genitourinary and sexual function from baseline following ADT and FT by measuring the subject's HRQoL	6-and 12-months after FT

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: Janssen, LP
• Investigators: Principal Investigator: Abhinav Sidana, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2025
• Primary Completion (Estimated): December 18, 2028
• Study Completion (Estimated): December 18, 2028

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens
• Other Study ID Numbers: IRB24-0259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No