Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT06705803

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Prostate Ablation

Study Details

Brief summary:

Prostate cancer (PCa) is the most commonly diagnosed non-cutaneous cancer of men in the world. In 2023 alone, it is estimated that 288,300 US men will be diagnosed with prostate cancer and 34,700 will die from the disease despite the approval of multiple systemic agents. Due to advances in screening and imaging technology, PCa is now detected much earlier in its disease course. Prostate gland ablation for prostate cancer might provide the option for a "middle" ground between active surveillance (AS) and radical therapy by destroying prostate cancer in a minimally invasive or non-invasive fashion and thus limiting the morbidity. This treatment strategy is increasingly being offered to patients due to low morbidity but the data on long term oncologic efficacy and side effect profile is lacking for such a treatment strategy.

The purpose of this study is to create a database and prospective registry for data collection on patients with prostate cancer undergoing prostate ablation for the management of prostate cancer. Patients with biopsy-proven prostate cancer of any Gleason Grade will be entered into the registry as long as prostate ablation is used as the prostate cancer management modality. Historical data from 2017 to the present time will be added through chart review. Current and future patient data will be collected through chart review during the subject's clinical care. Only data available in the electronic medical record will be collected and no additional data will be collected for research purposes. No biospecimens will be collected, and there are no physical risks from study participation.

Conditions

Prostate Cancer

Study ID

NCT06705803

Start date

Jun 21, 2024

Status verified date

Jan, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male sex
  • ≥22 years of age
  • Histologic diagnosis of prostate cancer
  • Scheduled to undergo or have already undergone ablation of the prostate as part of routine clinical care or any ongoing clinical trials
  • Prostate ablation performed with any of the following energy sources: cryotherapy, high-intensity focused ultrasound, irreversible electroporation, laser, microwave, radiofrequency ablation, or photodynamic therapy. Newer methods and instrumentation continue to be developed to ablate tissue, and these energy sources can be entered into the registry as clinical use begins

Exclusion Criteria:

  • Under 21 Years of age.

Study Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

Prostate Cancer Patients Undergoing Prostate Ablation

Patients with prostate cancer undergoing prostate ablation for the management of prostate cancer.

Interventions

Prostate Ablation

Patients with prostate cancer undergoing prostate ablation for the management of prostate cancer.

Primary outcome measure

  • Number of Participants with descriptive summarization of Prostate specific antigen (PSA) and its derivatives to represent clinicopathologic, interventions, and oncological outcomes [ Time Frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management. ]
  • Number of Participants with descriptive summarization of prostate biopsy [ Time Frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management. ]
  • Number of Participants with descriptive summarization of biomarkers [ Time Frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management. ]
  • Number of Participants with descriptive summarization of imaging findings [ Time Frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management. ]
  • Number of Participants with descriptive summarization of urination function [ Time Frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management. ]
  • Number of Participants with descriptive summarization of bowel function [ Time Frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management. ]
  • Number of Participants with descriptive summarization of sexual function [ Time Frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management. ]
  • Number of Participants with descriptive summarization of the overall quality of life parameters [ Time Frame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management. ]

Central Contacts and Locations

Central contacts

Abhinav Sidana, MD

773-834-5087abhinav.sidana@bsd.uchicago.edu

Leila Yazdanbakhsh

773-834-5087leila.yazdanbakhsh@bsd.uchicago.edu

Locations

The University of Chicago

Recruiting

Hyde Park, Illinois, United States, 60637

Contacts

Leila Yazdanbakhsh

7738345087leila.yazdanbakhsh@bsd.uchicago.edu

Principal Investigator:

Abinav Sidana, MD

The University of Cinncinatti

Recruiting

Cincinnati, Ohio, United States, 45221

Contacts

Sadhna Verma, MD

vermasm@ucmail.uc.edu

Shima Tayebi

tayebisa@ucmail.uc.edu

Principal Investigator:

Sadhna Verma, MD

More Information

Sponsor

University of Chicago

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-02-02.