Prostatic Artery Embolization in Advanced Prostate Cancer

NCT ID: NCT03457805

Last Updated: 2021-01-26

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-02

Study Completion Date

2021-08-02

Brief Summary

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This is a pilot study assessing efficacy and safety in patients with advanced prostate cancer.

Detailed Description

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PAE has been shown to be safe and effective in the treatment of prostatic bleeding and lower urinary tract symptoms arising from bladder outlet obstruction.

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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Prostate Cancer Bladder Outlet Obstruction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prostatic Artery Embolization (PAE)

PAE performed under local anesthesia using officially approved microspheres.

Group Type OTHER

Prostatic Artery Embolization

Intervention Type DEVICE

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).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Advanced PCA (i.e., locally advanced, metastatic, combination of both. This includes T3-4, any T in case of N1 and any T in case of M1a/b/c)
* 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

* Curative treatment of PCA intended
* 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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Dominik Abt

OTHER

Sponsor Role lead

Responsible Party

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Dominik Abt

Dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Dominik Abt, MD

Role: CONTACT

+41714941418

Facility Contacts

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Dominik Abt, MD

Role: primary

+41714941416

Gautier Müllhaupt, MD

Role: backup

+41714941416

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.

Reference Type DERIVED
PMID: 38416176 (View on PubMed)

Other Identifiers

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CTU17/028

Identifier Type: -

Identifier Source: org_study_id

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