Prostate CancerPhase 2NCT05790213
Prostate Cancer Treatment Using Androgen Deprivation Therapy and Focal Prostate Ablation
A Phase 2 study testing Androgen Deprivation Therapy (ADT) and Focal prostate ablation (focal therapy) in people with Prostate Cancer, run by University of Chicago at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Androgen Deprivation Therapy (ADT) and Focal prostate ablation (focal therapy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2025to 18 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have intermediate-risk PCa as defined by the below criteria:
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UChicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Cancer Intake, 1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Abhinav Sidana, MD
About this study
Official title: 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).
- Conditions
- Prostate Cancer
- Being tested
- Androgen Deprivation Therapy (ADT), Focal prostate ablation (focal therapy)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgen Deprivation Therapy (ADT)Drug
ADT will be given for 3 months. Participants will receive a standard ADT as chosen by their study doctor.
Focal prostate ablation (focal therapy)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Participants will receive Androgen deprivation therapy (ADT) followed by Focal prostate ablation (focal therapy) Receives: Drug: Androgen Deprivation Therapy (ADT); Procedure: Focal prostate ablation (focal therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6-months following treatment
Secondary outcomes (5)
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
Measured: 6-and 12-months after FT
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6-, 9- and 12-months after FT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start5 May 2025
- Primary completion18 Dec 2028 (estimated)
- Study completion18 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abhinav Sidana, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790213
- Sponsor's protocol ID
- IRB24-0259
- Status last verified
- Jun 2026
- First submitted
- 7 Feb 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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 41401176
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Focal Prostate Ablation Combined With Androgen Deprivation Therapy for Prostate Cancer Treatment
- ClinicalTrials.gov ID
- NCT05790213
- Acronym / sponsor ID
- IRB24-0259
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 18 Dec 2028 (estimated)
- Study completion
- 18 Dec 2028 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Androgen Deprivation Therapy (ADT), Procedure: Focal prostate ablation (focal therapy)Participants will receive Androgen deprivation therapy (ADT) followed by Focal prostate ablation (focal therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Androgen Deprivation Therapy (ADT)ADT will be given for 3 months. Participants will receive a standard ADT as chosen by their study doctor. | Drug | Treatment Arm |
| 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. | Procedure or surgery | Treatment Arm |
Primary outcome
Number of participants with clinically significant residual prostate cancer in ablated prostate tissue following study treatment
Time frame: End 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 treatment
Time frame: End 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]
Time frame: 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.
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Derived from this study: PubMed 41401176Koehler 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abhinav Sidana, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Androgen Deprivation Therapy (ADT) and Focal prostate ablation (focal therapy) in people with Prostate Cancer, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Intake (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with clinically significant residual prostate cancer in ablated prostate tissue following study treatment (time frame: End of Treatment (approximately 4-5 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05790213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.