RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-21
Study Completion:2029-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06705803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male sex
  2. * ≥22 years of age
  3. * Histologic diagnosis of prostate cancer
  4. * Scheduled to undergo or have already undergone ablation of the prostate as part of routine clinical care or any ongoing clinical trials
  5. * 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
  1. * Under 21 Years of age.

Contacts and Locations

Study Contact

Abhinav Sidana, MD
CONTACT
773-834-5087
abhinav.sidana@bsd.uchicago.edu
Leila Yazdanbakhsh
CONTACT
773-834-5087
leila.yazdanbakhsh@bsd.uchicago.edu

Principal Investigator

Abhinav Sidana, MD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

The University of Chicago
Hyde Park, Illinois, 60637
United States
The University of Cinncinatti
Cincinnati, Ohio, 45221
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Abhinav Sidana, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-21
Study Completion Date2029-06

Study Record Updates

Study Start Date2024-06-21
Study Completion Date2029-06

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Cancer