Clinical trial NCT06705803: Prostate Ablation Registry and Database for Information, Surveillance, and Evaluation (PARADISE)
Official title: Prostate Ablation Registry and Database for Information, Surveillance, and Evaluation (PARADISE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: University of Cincinnati
First posted: 2024-11-26
Enrollment: 3000
Sex: MALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with descriptive summarization of Prostate specific antigen (PSA) and its derivatives to represent clinicopathologic, interventions, and oncological outcomes
timeFrame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
measure: Number of Participants with descriptive summarization of prostate biopsy
timeFrame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
measure: Number of Participants with descriptive summarization of biomarkers
timeFrame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
measure: Number of Participants with descriptive summarization of imaging findings
timeFrame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
measure: Number of Participants with descriptive summarization of urination function
timeFrame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
measure: Number of Participants with descriptive summarization of bowel function
timeFrame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
measure: Number of Participants with descriptive summarization of sexual function
timeFrame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
measure: Number of Participants with descriptive summarization of the overall quality of life parameters
timeFrame: 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:
measure: Incidence of Treatment-Emergent Adverse Events of prostate gland ablation in patients with localized prostate cancer measured on a continuous scale.
timeFrame: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.
Other outcomes:
Locations:
city: Hyde Park
country: United States
facility: The University of Chicago
state: Illinois
city: Cincinnati
country: United States
facility: The University of Cinncinatti
state: Ohio
Study officials:
affiliation: University of Chicago
name: Abhinav Sidana, MD
role: PRINCIPAL_INVESTIGATOR
References: