Prostatic Artery Embolization in Advanced Prostate Cancer

  • STATUS
    Recruiting
  • days left to enroll
    42
  • participants needed
    20
  • sponsor
    Dominik Abt
Updated on 28 January 2021

Summary

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

Description

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.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Bladder neck obstruction, bladder disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, Bladder Disorders, prostate carcinoma, bladder outlet obstruction, prostate cancers
Treatment Prostatic Artery Embolization
Clinical Study IdentifierNCT03457805
SponsorDominik Abt
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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