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.
Study Type
OBSERVATIONAL
Enrollment
3,000
Patients with prostate cancer undergoing prostate ablation for the management of prostate cancer.
The University of Chicago
Hyde Park, Illinois, United States
RECRUITINGThe University of Cinncinatti
Cincinnati, Ohio, United States
RECRUITINGNumber of Participants with descriptive summarization of Prostate specific antigen (PSA) and its derivatives to represent clinicopathologic, interventions, and oncological outcomes
Descriptive summarization of Prostate specific antigen (PSA) and its derivatives
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.
Number of Participants with descriptive summarization of prostate biopsy
Descriptive summarization of prostate biopsy 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.
Number of Participants with descriptive summarization of biomarkers
Descriptive summarization of biomarkers 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.
Number of Participants with descriptive summarization of imaging findings
Descriptive summarization of imaging findings 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.
Number of Participants with descriptive summarization of urination function
Descriptive summarization of urination function to represent clinicopathologic, interventions, and genitourinary functional 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.
Number of Participants with descriptive summarization of bowel function
Descriptive summarization of bowel function to represent clinicopathologic, interventions, and genitourinary functional 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.
Number of Participants with descriptive summarization of sexual function
Descriptive summarization of sexual function to represent clinicopathologic, interventions, and genitourinary functional 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.
Number of Participants with descriptive summarization of the overall quality of life parameters
Descriptive summarization of the overall quality of life parameters to represent clinicopathologic, interventions, and genitourinary functional 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.
Incidence of Treatment-Emergent Adverse Events of prostate gland ablation in patients with localized prostate cancer measured on a continuous scale.
Data measured on a continuous scale will be expressed as a mean, standard deviation when normally distributed and as a median and interquartile range, when non-normally distributed.
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.
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