An interventional study of Prostatic Artery Embolization (PAE) in Prostate Cancer, sponsored by Dominik Abt. Completed at 2 sites in Switzerland. Open to male participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-08-09.
Sponsored by Dominik Abt · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
PAE is performed 6weeks before RALP
Device: Prostatic Artery Embolization (PAE)
PAE is performed 6 weeks before radical prostatectomy
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.
Time frame: 6 weeks after PAE (at the time of RALP)
Histological Tumor Regression Grade
Time frame: 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.
Time frame: 6 weeks after PAE (at the time of RALP)
Assessment of Adverse Events of PAE according to CTCAE V4.03
Time frame: At the time of PAE and 6 weeks afterwards
Assessment of Adverse Events of PAE according to Clavien-Dindo classification
Time frame: At the time of PAE and 6 weeks afterwards
Assessment of Adverse Events of RALP after PAE according to CTCAE V4.03
Time frame: At the time of RALP, 6 weeks and 12 weeks later
Assessment of Adverse Events of RALP after PAE according to Clavien-Dindo classification
Time frame: At the time of RALP, 6 weeks and 12 weeks later
Change of prostate volume in MRI after PAE
Time frame: Before and 6 weeks after PAE
Change of tumor detection rate in MRI after PAE
Time frame: Before and 6 weeks after PAE
Change of tumor size in MRI after PAE
Time frame: Before and 6 weeks after PAE
Change of PIRADS classification in MRI after PAE
Time frame: Before and 6 weeks after PAE
Plan to share: No
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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Dominik Abt