Clinical trial NCT03457805: Prostatic Artery Embolization in Advanced Prostate Cancer
Official title: Prostatic Artery Embolization (PAE) in Patients With Advanced Prostate Cancer: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Bladder Outlet Obstruction
Keywords: prostate cancer
prostate
embolization
minimally invasive
cytoreductive therapy
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 20
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Reduction of Lower Urinary Tract Symptoms
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Reduction of Lower Urinary Tract Symptoms
timeFrame: Baseline and 6 weeks
measure: Reduction of Lower Urinary Tract Symptoms
timeFrame: Baseline and 6 months
measure: Reduction of Lower Urinary Tract Symptoms
timeFrame: Baseline and 12 months
measure: Occurrence of macroscopic hematuria
timeFrame: From time of PAE to study completion (1 year)
measure: Reduction of Prostate symptoms
timeFrame: baseline and 6 weeks
measure: Reduction of Prostate symptoms
timeFrame: baseline and 12 weeks
measure: Reduction of Prostate symptoms
timeFrame: baseline and 6 months
measure: Reduction of Prostate symptoms
timeFrame: baseline and 12 months
measure: Occurrence of urinary incontinence
timeFrame: 6 week after PAE
measure: Occurrence of urinary incontinence
timeFrame: 12 week after PAE
measure: Occurrence of urinary incontinence
timeFrame: 6 months after PAE
measure: Occurrence of urinary incontinence
timeFrame: 12 months after PAE
measure: Changes of free urinary flow rate
timeFrame: Baseline and 6 weeks
measure: Changes of free urinary flow rate
timeFrame: Baseline and 12 weeks
measure: Changes of free urinary flow rate
timeFrame: Baseline and 6 months
measure: Changes of free urinary flow rate
timeFrame: Baseline and 12 months
measure: Changes of post void residual urine
timeFrame: Baseline and 6 weeks
measure: Changes of post void residual urine
timeFrame: Baseline and 12 weeks
measure: Changes of post void residual urine
timeFrame: Baseline and 6 months
measure: Changes of post void residual urine
timeFrame: Baseline and 12 months
measure: Rate of local reinterventions
timeFrame: During 1 year study period
measure: Intraoperative Adverse Events
timeFrame: While PAE is performed (intra-operatively)
measure: Adverse Events
timeFrame: 6 weeks after PAE
measure: Adverse Events
timeFrame: 12 weeks after PAE
measure: Adverse Events
timeFrame: 6 months after PAE
measure: Adverse Events
timeFrame: 12 months after PAE
measure: Feasibility of PAE
timeFrame: While PAE is performed (intra-operatively)
measure: Estimation of tumor burden
timeFrame: Baseline and 24h after PAE
measure: Estimation of tumor burden
timeFrame: Baseline and 6 weeks after PAE
measure: Estimation of tumor burden
timeFrame: Baseline and 12 weeks after PAE
measure: Estimation of tumor burden
timeFrame: Baseline and 6 months after PAE
measure: Estimation of tumor burden
timeFrame: Baseline and 12 months after PAE
measure: Estimation of tumor volume
timeFrame: Baseline and 12 weeks after PAE
measure: Prostate volume
timeFrame: Baseline and 12 weeks after PAE
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital St. Gallen
state: Saint Gallen
Study officials:
affiliation: St. Gallen Cantonal Hospital, Dept. of Urology, Rorschacherstrasse 95, 9007 St. Gallen
name: Dominik Abt, MD
role: PRINCIPAL_INVESTIGATOR
References: