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| Name | Class |
|---|---|
| University of Cincinnati | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate Cancer Patients Undergoing Prostate Ablation | Patients with prostate cancer undergoing prostate ablation for the management of prostate cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostate Ablation | Procedure | Patients with prostate cancer undergoing prostate ablation for the management of prostate cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number 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 | 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 | 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 | 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 | 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 | Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abhinav Sidana, MD | Contact | 773-834-5087 | abhinav.sidana@bsd.uchicago.edu | |
| Leila Yazdanbakhsh | Contact | 773-834-5087 | leila.yazdanbakhsh@bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Abhinav Sidana, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Recruiting | Hyde Park | Illinois | 60637 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D020728 | Transurethral Resection of Prostate |
| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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| Number of Participants with descriptive summarization of bowel function | Descriptive summarization of bowel function to represent clinicopathologic, interventions, and genitourinary functional outcomes | 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 | 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 | Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management. |
| The University of Cinncinatti | Recruiting | Cincinnati | Ohio | 45221 | United States |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D013514 | Surgical Procedures, Operative |