Prostatic Artery Embolization in Advanced Prostate Cancer
NCT ID: NCT03457805
Last Updated: 2021-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2018-03-02
2021-08-02
Brief Summary
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Detailed Description
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Advanced (defined as locally advanced, metastatic or both in this study) PCA is frequently associated with both of these conditions. The currently most frequently performed palliative surgical treatment is TURP. Though performed endoscopically, TURP is associated with significant side effects in this setting. PAE has been shown to have a superior side-effect profile in the treatment of bladder outlet obstruction compared to TURP.
In addition, there is growing evidence that patients with advanced PCA might benefit from cytoreductive therapy (e.g. radical prostatectomy or external beam radiation therapy). However, recent methods of cytoreductive treatment of PCA hold the risk of being highly invasive and are associated with severe side effects. PAE might represent a minimally invasive alternative in this setting.
Therefore, efficacy and safety of PAE in patients with advanced prostate cancer is assessed in this pilot-study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prostatic Artery Embolization (PAE)
PAE performed under local anesthesia using officially approved microspheres.
Prostatic Artery Embolization
PAE is performed under local anesthesia using commercially available and approved microspheres (study is not limited to a specific manufacturer or product).
Interventions
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Prostatic Artery Embolization
PAE is performed under local anesthesia using commercially available and approved microspheres (study is not limited to a specific manufacturer or product).
Eligibility Criteria
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Inclusion Criteria
* PAE is indicated for the treatment of Lower urinary tract symptoms like bladder outlet obstruction or recurrent prostatic bleeding.
* IPSS at baseline ≥ 8
* Witten informed consent
Exclusion Criteria
* Contraindications for MRI
* Renal impairment (GFR \< 30ml/min)
* Allergy to i.v. contrast medium
* Vascular conditions that seem to make successful PAE impossible (e.g. severe atherosclerosis, severe tortuosity in the aortic bifurcation or internal iliac vessels)
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
* Drug-treatments for advanced prostate cancer (e.g., hormonal therapy or chemotherapy) established within 30 days prior to PAE.
MALE
No
Sponsors
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Dominik Abt
OTHER
Responsible Party
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Dominik Abt
Dr. med.
Principal Investigators
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Dominik Abt, MD
Role: PRINCIPAL_INVESTIGATOR
St. Gallen Cantonal Hospital, Dept. of Urology, Rorschacherstrasse 95, 9007 St. Gallen
Locations
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Cantonal Hospital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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Burkhardt O, Abt D, Hechelhammer L, Kim O, Omlin A, Schmid HP, Engeler D, Zumstein V, Mullhaupt G. Prostatic Artery Embolization in Patients with Advanced Prostate Cancer: A Prospective Single Center Pilot Study. Cardiovasc Intervent Radiol. 2024 Jun;47(6):771-782. doi: 10.1007/s00270-024-03679-z. Epub 2024 Feb 28.
Other Identifiers
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CTU17/028
Identifier Type: -
Identifier Source: org_study_id
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