RECRUITING

Prostate Cancer Treatment Using Androgen Deprivation Therapy and Focal Prostate Ablation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-08-17

Study Completion:2028-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05790213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.

Contacts and Locations

Study Contact

Cancer Intake

CONTACT

1-855-702-8222

cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator

Abhinav Sidana, MD

PRINCIPAL_INVESTIGATOR

University of Chicago

Study Locations (Sites)

UChicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Abhinav Sidana, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-17

Study Completion Date2028-04-01

Study Record Updates

Study Start Date2023-08-17

Study Completion Date2028-04-01

Terms related to this study

Additional Relevant MeSH Terms

Prostate Cancer