RecruitingNCT06705803

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


Sponsor

University of Chicago

Enrollment

3,000 participants

Start Date

Jun 21, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This is a registry study (not a treatment study) that collects long-term data on men with prostate cancer who have undergone or are planning to undergo focal ablation therapy — a minimally invasive procedure that destroys tumor tissue in the prostate using energy (such as ultrasound, freezing, or laser) without removing the whole gland. **You may be eligible if...** - You are male and at least 22 years old - You have a confirmed diagnosis of prostate cancer - You have undergone or are scheduled to undergo prostate ablation as part of your standard care or another clinical trial - Your ablation used methods such as cryotherapy, high-intensity focused ultrasound (HIFU), irreversible electroporation, laser, microwave, radiofrequency, or photodynamic therapy **You may NOT be eligible if...** - You are under 21 years of age Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREProstate Ablation

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


Locations(2)

The University of Chicago

Hyde Park, Illinois, United States

The University of Cinncinatti

Cincinnati, Ohio, United States

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NCT06705803


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