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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Dominik Abt is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
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