Prostate Ablation Registry and Database for Information, Surveillance, and Evaluation (PARADISE)

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Prostate Ablation

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Leila Yazdanbakhsh; Phone Number: 773-834-5087; Email: leila.yazdanbakhsh@bsd.uchicago.edu
• Study Contact Backup: Name: Abhinav Sidana, MD; Phone Number: 773-834-5087; Email: abhinav.sidana@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Hyde Park, Illinois, United States, 60637
      • Recruiting
      • The University of Chicago
      • Contact: Leila Yazdanbakhsh; Phone Number: 7738345087; Email: leila.yazdanbakhsh@bsd.uchicago.edu
      • Contact: Abhinav Sidana, MD
      • Principal Investigator: Abinav Sidana, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45221
      • Recruiting
      • The University of Cinncinatti
      • Principal Investigator: Sadhna Verma, MD
      • Contact: Sadhna Verma, MD; Email: vermasm@ucmail.uc.edu
      • Contact: Shima Tayebi; Email: tayebisa@ucmail.uc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will collect data on all consecutive patients who have undergone prostate ablation at University of Chicago Medical Center without any exclusions. Patients will be consented at the UCMC campus as well as at River East.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prostate Cancer Patients Undergoing Prostate Ablation; Patients with prostate cancer undergoing prostate ablation for the management of prostate cancer.	Procedure: Prostate Ablation; Patients with prostate cancer undergoing prostate ablation for the management of prostate cancer.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events of prostate gland ablation in patients with localized prostate cancer measured on a continuous scale.	Data measured on a continuous scale will be expressed as a mean, standard deviation when normally distributed and as a median and interquartile range, when non-normally distributed.	Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: University of Cincinnati
• Investigators: Principal Investigator: Abhinav Sidana, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures; Urologic Surgical Procedures, Male; Prostatectomy; Transurethral Resection of Prostate
• Other Study ID Numbers: IRB 24-0111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No