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| Name | Class |
|---|---|
| Catharina Ziekenhuis Eindhoven | OTHER |
| Canisius-Wilhelmina Hospital | OTHER |
| Maxima Medical Center | OTHER |
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The clinical objective for this pilot study is to determine whether minimal residual disease (MRD) detection in high-risk prostate cancer, utilizing a custom-made prostate-specific circulating tumor DNA (ctDNA) panel, may lead to more optimal prediction of disease recurrence following radical prostatectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-risk localized prostate cancer or high-risk locally advanced prostate cancer | Included patients will have:
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| Measure | Description | Time Frame |
|---|---|---|
| The proportion of high-risk prostate cancer patients in which ctDNA-detected minimal residual disease (MRD) exceeds 15% | To determine the proportion of high-risk prostate cancer patients with ctDNA-detected minimal residual disease (MRD) at six weeks postoperatively | From enrollment to 6 weeks postoperatively |
| The relation between distant disease-free survival (DDFS) <12 months and minimal residual disease (MRD) positive patients | To determine the risk of early relapse (radiological distant disease-free survival within twelve months following prostatectomy) in patients with and without ctDNA-detected minimal residual disease (MRD) | From enrollment to 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| The relation between distant disease-free survival (DDFS) and 12-week ctDNA-positive patients | To determine the proportion of HR-PCa with ctDNA-detected early relapse at 12 weeks postoperatively | From enrollment to 12 months postoperatively |
| The relation between ctDNA% and distant disease-free survival (DDFS) |
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Inclusion Criteria:
Male aged 18 years or older;
High-risk prostate cancer, defined as:
Scheduled for robot-assisted radical prostatectomy;
Willingness to consent to both patient information sheets regarding tissue and liquid biobanking.
Exclusion Criteria:
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Patients with high-risk prostate cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prosper Prostate Cancer Clinics | Recruiting | Nijmegen | Netherlands |
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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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Circulating tumor DNA (ctDNA)
To determine the preoperative ctDNA fractional abundance (ctDNA%) and the prognostic characteristics of ctDNA% related to early relapse and radiological disease-free survival |
| From enrollment to 12 months postoperatively |
| The relation between poor prognostic gene signature (TP53 and/or PTEN) and/or DNA damage repair alterations and distant disease-free survival (DDFS) | To determine whether mutations in TP53, PTEN and DNA damage repair are associated with early distant metastasis-free survival | From enrollment to 12 months postoperatively |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |