Prostatic Artery Embolization in Advanced Prostate Cancer

Dominik Abt

Status

Unknown

Conditions

Bladder Outlet Obstruction

Prostate Cancer

Treatments

Device: Prostatic Artery Embolization

Study type

Interventional

Funder types

Other

Identifiers

NCT03457805

CTU17/028

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

Male

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.