An interventional study of Prostatic Artery Embolization in Prostate Cancer and Bladder Outlet Obstruction, sponsored by Dominik Abt. Status unknown at 1 site in Switzerland. Open to male participants. Per ClinicalTrials.gov, last updated 2021-01-26.
Sponsored by Dominik Abt · Not applicable, Interventional, and Treatment
This is a pilot study assessing efficacy and safety in patients with advanced prostate cancer.
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Dominik Abt is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PAE performed under local anesthesia using officially approved microspheres.
Device: 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).
Reduction of Lower Urinary Tract Symptoms
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time frame: Baseline and 12 weeks
Reduction of Lower Urinary Tract Symptoms
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time frame: Baseline and 6 weeks
Reduction of Lower Urinary Tract Symptoms
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time frame: Baseline and 6 months
Reduction of Lower Urinary Tract Symptoms
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time frame: Baseline and 12 months
Occurrence of macroscopic hematuria
Assessment of occurrence of hematuria according to CTCAE v.4.03 classification
Time frame: From time of PAE to study completion (1 year)
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time frame: baseline and 6 weeks
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time frame: baseline and 12 weeks
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time frame: baseline and 6 months
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time frame: baseline and 12 months
Occurrence of urinary incontinence
Assessment of ICS-SF questionnaire
Time frame: 6 week after PAE
Occurrence of urinary incontinence
Assessment of ICS-SF questionnaire
Time frame: 12 week after PAE
Occurrence of urinary incontinence
Assessment of ICS-SF questionnaire
Time frame: 6 months after PAE
Occurrence of urinary incontinence
Assessment of ICS-SF questionnaire
Time frame: 12 months after PAE
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time frame: Baseline and 6 weeks
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time frame: Baseline and 12 weeks
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time frame: Baseline and 6 months
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time frame: Baseline and 12 months
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time frame: Baseline and 6 weeks
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time frame: Baseline and 12 weeks
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time frame: Baseline and 6 months
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time frame: Baseline and 12 months
Rate of local reinterventions
Assessment of number and type of reinterventions for prostate and bladder problems
Time frame: During 1 year study period
Intraoperative Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time frame: While PAE is performed (intra-operatively)
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time frame: 6 weeks after PAE
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time frame: 12 weeks after PAE
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time frame: 6 months after PAE
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time frame: 12 months after PAE
Feasibility of PAE
Possibility of successful completion of PAE in the study cohort defined by compete stasis of blood flow in the prostate
Time frame: While PAE is performed (intra-operatively)
Estimation of tumor burden
Changes of Prostate Specific Antigen
Time frame: Baseline and 24h after PAE
Estimation of tumor burden
Changes of Prostate Specific Antigen
Time frame: Baseline and 6 weeks after PAE
Estimation of tumor burden
Changes of Prostate Specific Antigen
Time frame: Baseline and 12 weeks after PAE
Estimation of tumor burden
Changes of Prostate Specific Antigen
Time frame: Baseline and 6 months after PAE
Estimation of tumor burden
Changes of Prostate Specific Antigen
Time frame: Baseline and 12 months after PAE
Estimation of tumor volume
Change of tumor volume calculated by magnetic resonance imaging
Time frame: Baseline and 12 weeks after PAE
Prostate volume
Change of prostate volume calculated by magnetic resonance imaging
Time frame: Baseline and 12 weeks after PAE
Plan to share: Undecided — Decision will be made individually up on request and based on approval by our local ethics committee.
No publications or documents are linked to this record.
Started Mar 2018 (actual). Primary completion is estimated for Jul 2021, 40 months after the start.
Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 40 months is close to that.
Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Dominik Abt