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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety and how well it works to combine focal therapy with hormone therapy for prostate cancer. Focal therapy is surgery to treat part of the prostate. The study is for adult men with medium-risk prostate cancer that has not spread.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be a man age 18 or older with medium-risk prostate cancer. The study team will check cancer stage, grade, PSA blood levels, and tissue samples.
- Have no cancer spread outside the prostate or into nearby glands that make semen on MRI. If spread into these glands is suspected, a tissue sample must rule it out.
- If your cancer is in the higher-risk part of the medium-risk group, have scans within 6 months before joining that confirm it has not spread. Extra scans are not needed for the lower-risk group.
- Have chosen focal therapy and be able to safely have the surgery and medicine that keeps you asleep during it. The surgeon must be able to see and reach the treatment area.
- Be expected by the study doctor to live at least 10 years and meet the study's rules for daily activity and self-care.
- Meet blood test rules for blood cell counts, liver and kidney function, protein, and potassium. Another cancer is allowed if it will not affect study safety or results.
- If sexually active with a woman who could become pregnant, use a condom with sperm-killing medicine. Your partner must also use highly effective birth control during treatment and for 3 months after the last hormone treatment.
- Be able to understand the study and willing to sign a consent form.
Who can't join
- Have had or are receiving prostate cancer treatment. Also excluded: radiation to the pelvis, chemotherapy, or immune treatment for another cancer within 6 months before joining.
- Have prostate cancer that has grown into nearby areas, lymph nodes, or distant parts of the body.
- Cannot safely have a pelvic MRI, such as because of severe fear of tight spaces, certain implants, or problems with the contrast dye.
- Have an allergy to, or cannot tolerate, ingredients in the study drugs.
- Have had both testicles removed.
- Have another illness that is not controlled or causes major weakness or disability.
- Are receiving another experimental treatment. Past use may be allowed if the lead study doctor approves.
- The study doctor thinks the study is not suitable for you or that you are unlikely to follow its rules and procedures.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
IL
- UChicago Medicine Comprehensive Cancer Center · Chicago, IL 60637Cancer Intake · Study contact · 1-855-702-8222 · cancerclinicaltrials@bsd.uchicago.eduAbhinav Sidana, MD · Principal investigatorMore trials in Chicago