Prostate Cancer
Conditions
Keywords
Prostate, Prostatic Neoplams, Therapeutic Embolization, Prostatectomy
Brief summary
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.
Detailed description
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.
Interventions
PAE is performed 6 weeks before radical prostatectomy
Sponsors
Dominik Abt
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Men 45 - 75 years old undergoing RALP * Patient has biopsy-proven prostate adenocarcinoma * Localized disease (tumorstage cT1-cT2), assessed by clinical and MRI findings * Written informed consent
Exclusion criteria
* Severe atherosclerosis * Severe tortuosity or ectasia in the aortic bifurcation or internal iliac arteries * Tumor stage \> cT2 assessed by clinical and MRI findings * Allergy to intravenous contrast media * Contraindication for MRI imaging * Renal failure (GFR\<60ml/min) * History of pelvic irradiation or radical pelvic surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response | 6 weeks after PAE (at the time of RALP) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of PIRADS classification in MRI after PAE | Before and 6 weeks after PAE | — |
| Histological Tumor Regression Grade | 6 weeks after PAE (at the time of RALP) | — |
| Surgical margins assessment (R0 /R1) | 6 weeks after PAE (at the time of RALP) | \- Success of radical prostatectomy defined as the complete resection of cancerous prostate gland tissue and completely negative surgical margins. |
| Assessment of Adverse Events of PAE according to CTCAE V4.03 | At the time of PAE and 6 weeks afterwards | — |
| Change of tumor size in MRI after PAE | Before and 6 weeks after PAE | — |
| 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 | — |
| Assessment of Adverse Events of PAE according to Clavien-Dindo classification | At the time of PAE and 6 weeks afterwards | — |
Countries
Switzerland
Outcome results
None listed