Combining hormone therapy and focal ablation for prostate cancer treatment

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

This study is testing whether combining hormone therapy with focal ablation can help men with intermediate-risk prostate cancer have better treatment results.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University of Chicago (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT05790213 on ClinicalTrials.gov

What this trial studies

This research aims to evaluate the safety and effectiveness of combining androgen deprivation therapy (ADT) with focal prostate ablation therapy in patients with intermediate-risk prostate cancer. The study will involve patients who have chosen focal therapy as their treatment option and will assess their response to the combined therapies. Participants will undergo standard screening to confirm non-metastatic prostate cancer before being enrolled in the trial. The goal is to determine if this combination approach can improve treatment outcomes for patients.

Who should consider this trial

Good fit: Ideal candidates for this study are men with intermediate-risk prostate cancer who have chosen focal therapy as their treatment option.

Not a fit: Patients with advanced prostate cancer or those who do not meet the specific criteria for intermediate-risk prostate cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective treatment option for patients with intermediate-risk prostate cancer.

How similar studies have performed: Other studies have explored similar combinations of therapies for prostate cancer, showing promising results, but this specific approach is still being evaluated.

Eligibility criteria

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.

Where this trial is running

Chicago, Illinois

• UChicago Medicine Comprehensive Cancer Center — Chicago, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Abhinav Sidana, MD — University of Chicago
• Study coordinator: Cancer Intake

Conditions Prostate Cancer