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MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer.
This proof of concept study assess the impact of PAE in patients with proven prostate cancer.
MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer.
This proof of concept study assess the impact of PAE in patients with proven prostate cancer.
PAE is performed in patients that are planned to undergo robot-assisted laparoscopic prostatectomy for proven localized prostate cancer.
The impact of neo-adjuvantly performed PAE on histological tumor regression, surgical margins as well as on safety parameters are assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostatic Artery Embolization (PAE) | Experimental | PAE is performed 6weeks before RALP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostatic Artery Embolization (PAE) | Device | PAE is performed 6 weeks before radical prostatectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response | Histological assessment of the excised prostate to determine whether pathological complete response was achieved, defined as complete absence of histologically identifiable cancer cells in the excised prostate. | 6 weeks after PAE (at the time of RALP) |
| Measure | Description | Time Frame |
|---|---|---|
| Histological Tumor Regression Grade | 6 weeks after PAE (at the time of RALP) | |
| Surgical margins assessment (R0 /R1) | - Success of radical prostatectomy defined as the complete resection of cancerous prostate gland tissue and completely negative surgical margins. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominik Abt, MD | Cantonal Hospital of St. Gallen | Principal Investigator |
| Livio Mordasini, MD | Cantonal Hospital Luzerne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cantonal Hospital Lucerne, Department of Urology | Lucerne | 6000 | Switzerland | |||
| Urological Department, Cantonal Hospital of St. Gallen |
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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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| 6 weeks after PAE (at the time of RALP) |
| Assessment of Adverse Events of PAE according to CTCAE V4.03 | At the time of PAE and 6 weeks afterwards |
| Assessment of Adverse Events of PAE according to Clavien-Dindo classification | At the time of PAE and 6 weeks afterwards |
| Assessment of Adverse Events of RALP after PAE according to CTCAE V4.03 | At the time of RALP, 6 weeks and 12 weeks later |
| Assessment of Adverse Events of RALP after PAE according to Clavien-Dindo classification | At the time of RALP, 6 weeks and 12 weeks later |
| Change of prostate volume in MRI after PAE | Before and 6 weeks after PAE |
| Change of tumor detection rate in MRI after PAE | Before and 6 weeks after PAE |
| Change of tumor size in MRI after PAE | Before and 6 weeks after PAE |
| Change of PIRADS classification in MRI after PAE | Before and 6 weeks after PAE |
| Sankt Gallen |
| 9007 |
| Switzerland |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |