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

Part of paid clinical trials in Hyde Park, Illinois.

Sponsor
University of Chicago
Study ID
NCT06705803
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prostate Ablation — PROCEDURE
    Patients with prostate cancer undergoing prostate ablation for the management of prostate cancer.

Study Details

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.

Key Dates

Start date
Jun 21, 2024
Status verified
Jan 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: Prostate Cancer Patients Undergoing 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. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The University of ChicagoHyde ParkIllinois60637
Abhinav Sidana, MD
Leila Yazdanbakhsh
[email protected]
7738345087
Abinav Sidana, MD (PRINCIPAL_INVESTIGATOR)
The University of CinncinattiCincinnatiOhio45221
Sadhna Verma, MD
[email protected]
Shima Tayebi
[email protected]
Sadhna Verma, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Hyde Park, IL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
The University of Chicago· Hyde Park, ILThe University of Cinncinatti· Cincinnati, OH

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