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

NCT ID: NCT06705803

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-21

Study Completion Date

2029-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prostate Cancer Patients Undergoing Prostate Ablation

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

Prostate Ablation

Intervention Type PROCEDURE

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

Interventions

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Prostate Ablation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

22 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Cincinnati

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abhinav Sidana, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Hyde Park, Illinois, United States

Site Status RECRUITING

The University of Cinncinatti

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Abhinav Sidana, MD

Role: CONTACT

Phone: 773-834-5087

Email: [email protected]

Leila Yazdanbakhsh

Role: CONTACT

Phone: 773-834-5087

Email: [email protected]

Facility Contacts

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Abhinav Sidana, MD

Role: primary

Leila Yazdanbakhsh

Role: backup

Sadhna Verma, MD

Role: primary

Shima Tayebi

Role: backup

Other Identifiers

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IRB 24-0111

Identifier Type: -

Identifier Source: org_study_id