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Prostate Cancer Treatment with Androgen Deprivation Therapy and Focal Ablation

This study is looking into how safe and effective it is to combine two treatments for prostate cancer: androgen deprivation therapy (ADT), which is a hormone therapy, and focal prostate ablation (a surgical procedure). You may be able to join if you are a man aged 18 or older with intermediate-risk prostate cancer. Researchers will measure how many participants still have significant cancer in the treated or untreated parts of the prostate after treatment, and they will also track any complications for safety. The study aims to enroll 57 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 57 participants. It is testing a combination of a drug (Androgen Deprivation Therapy) and a procedure (Focal prostate ablation).
What's involved
You would receive androgen deprivation therapy (ADT) for 3 months, followed by focal prostate ablation. The primary outcomes are measured around 4-5 months after treatment, with safety tracked for 6 months after treatment.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track complications for 6 months after treatment. Other outcomes are measured at approximately 4-5 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05790213

Prostate Cancer Treatment Using Androgen Deprivation Therapy and Focal Prostate Ablation

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Chicago
~57 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:Androgen Deprivation Therapy (ADT)Focal prostate ablation (focal therapy)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with clinically significant residual prostate cancer in ablated prostate tissue following study treatment
Measured over End of Treatment (approximately 4-5 months)
+2 more outcomes measured

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Abhinav Sidana, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

Who to contact

Cancer Intake
[email protected]
1-855-702-8222
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of participants with clinically significant residual prostate cancer in ablated prostate tissue following study treatmentEnd of Treatment (approximately 4-5 months)

    Proportion of participants that have residual cancer in ablated prostate tissue. Residual disease will be measured by MRI.

  • Number of participants with clinically significant residual prostate cancer in unablated prostate tissue following study treatmentEnd of Treatment (approximately 4-5 months)

    Proportion of participants that have residual cancer in unablated prostate tissue. Residual disease will be measured by MRI.

  • Number and grade of complications [Safety]6-months following treatment

    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.