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

NCT06705803 | Recruiting DMC

• 1 other identifier: IRB 24-0111
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events of prostate gland ablation in patients with localized prostate cancer measured on a continuous scale.

  Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.

Study Arms (1)

Prostate Cancer Patients Undergoing Prostate Ablation

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

Procedure: Prostate Ablation

Interventions

Prostate Ablation PROCEDURE

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

Prostate Cancer Patients Undergoing Prostate Ablation

Eligibility Criteria

• Age: 22 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Under 21 Years of age.

Sponsors & Collaborators

• University of Chicago: lead
• University of Cincinnati: collaborator

Study Sites (2)

The University of Chicago

Hyde Park, Illinois, 60637, United States

RECRUITING

The University of Cinncinatti

Cincinnati, Ohio, 45221, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Abhinav Sidana, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abhinav Sidana, MD

CONTACT

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

Leila Yazdanbakhsh

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 26, 2024
• Study Start: June 21, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (2)