Prostate CancerNCT02917161
Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study
A study testing Prostatic Artery Embolization (PAE) in people with Prostate Cancer, run by Dominik Abt at 2 sites in Switzerland.
Trial summary
MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer. This proof of concept study assess the impact of PAE in patients with proven prostate cancer. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostatic Artery Embolization (PAE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Sep 2016to 3 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men 45 - 75 years old undergoing RALP
- Patient has biopsy-proven prostate adenocarcinoma
- Localized disease (tumorstage cT1-cT2), assessed by clinical and MRI findings
- Written informed consent
Who cannot join
- Severe atherosclerosis
- Severe tortuosity or ectasia in the aortic bifurcation or internal iliac arteries
- Tumor stage > cT2 assessed by clinical and MRI findings
- Allergy to intravenous contrast media
- Contraindication for MRI imaging
- Renal failure (GFR<60ml/min)
- History of pelvic irradiation or radical pelvic surgery
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Cantonal Hospital Lucerne, Department of Urology
Lucerne, 6000
Urological Department, Cantonal Hospital of St. Gallen
Sankt Gallen, 9007
About this study
MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer.
This proof of concept study assess the impact of PAE in patients with proven prostate cancer.
Read the detailed description
MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer.
This proof of concept study assess the impact of PAE in patients with proven prostate cancer.
PAE is performed in patients that are planned to undergo robot-assisted laparoscopic prostatectomy for proven localized prostate cancer.
The impact of neo-adjuvantly performed PAE on histological tumor regression, surgical margins as well as on safety parameters are assessed.
- Conditions
- Prostate Cancer
- Being tested
- Prostatic Artery Embolization (PAE)
- Keywords
- Prostate, Prostatic Neoplams, Therapeutic Embolization, Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostatic Artery Embolization (PAE)Device
PAE is performed 6 weeks before radical prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| Prostatic Artery Embolization (PAE) | Experimental | PAE is performed 6weeks before RALP Receives: Device: Prostatic Artery Embolization (PAE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response
Histological assessment of the excised prostate to determine whether pathological complete response was achieved, defined as complete absence of histologically identifiable cancer cells in the excised prostate.
Measured: 6 weeks after PAE (at the time of RALP)
Secondary outcomes (10)
Histological Tumor Regression Grade
Measured: 6 weeks after PAE (at the time of RALP)
Surgical margins assessment (R0 /R1)
- Success of radical prostatectomy defined as the complete resection of cancerous prostate gland tissue and completely negative surgical margins.
Measured: 6 weeks after PAE (at the time of RALP)
Assessment of Adverse Events of PAE according to CTCAE V4.03
Measured: At the time of PAE and 6 weeks afterwards
Assessment of Adverse Events of PAE according to Clavien-Dindo classification
Measured: At the time of PAE and 6 weeks afterwards
Assessment of Adverse Events of RALP after PAE according to CTCAE V4.03
Measured: At the time of RALP, 6 weeks and 12 weeks later
Assessment of Adverse Events of RALP after PAE according to Clavien-Dindo classification
Measured: At the time of RALP, 6 weeks and 12 weeks later
Change of prostate volume in MRI after PAE
Measured: Before and 6 weeks after PAE
Change of tumor detection rate in MRI after PAE
Measured: Before and 6 weeks after PAE
Change of tumor size in MRI after PAE
Measured: Before and 6 weeks after PAE
Change of PIRADS classification in MRI after PAE
Measured: Before and 6 weeks after PAE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2017
- Study completion3 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dominik Abt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dominik Abt, Cantonal Hospital of St. Gallen
- Investigators
- Dominik Abt, MD, Principal investigator, Cantonal Hospital of St. GallenLivio Mordasini, MD, Principal investigator, Cantonal Hospital Luzerne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917161
- Sponsor's protocol ID
- CTU 15/015
- Status last verified
- Aug 2017
- First submitted
- 24 Sep 2016
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT02917161
- Acronym / sponsor ID
- CTU 15/015
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Prostatic Neoplams, Therapeutic Embolization, Prostatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dominik AbtUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- 3 Aug 2017 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer.
This proof of concept study assess the impact of PAE in patients with proven prostate cancer.
Detailed description
MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer.
This proof of concept study assess the impact of PAE in patients with proven prostate cancer.
PAE is performed in patients that are planned to undergo robot-assisted laparoscopic prostatectomy for proven localized prostate cancer.
The impact of neo-adjuvantly performed PAE on histological tumor regression, surgical margins as well as on safety parameters are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostatic Artery Embolization (PAE) | Experimental | Device: Prostatic Artery Embolization (PAE)PAE is performed 6weeks before RALP |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men 45 - 75 years old undergoing RALP
- Patient has biopsy-proven prostate adenocarcinoma
- Localized disease (tumorstage cT1-cT2), assessed by clinical and MRI findings
- Written informed consent
Key exclusion criteria (7 listed)
- Severe atherosclerosis
- Severe tortuosity or ectasia in the aortic bifurcation or internal iliac arteries
- Tumor stage > cT2 assessed by clinical and MRI findings
- Allergy to intravenous contrast media
- Contraindication for MRI imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostatic Artery Embolization (PAE)PAE is performed 6 weeks before radical prostatectomy | Device | Prostatic Artery Embolization (PAE) |
Primary outcome
Tumor response
Time frame: 6 weeks after PAE (at the time of RALP)
Histological assessment of the excised prostate to determine whether pathological complete response was achieved, defined as complete absence of histologically identifiable cancer cells in the excised prostate.
10 secondary outcomes
Histological Tumor Regression Grade
Time frame: 6 weeks after PAE (at the time of RALP)
Surgical margins assessment (R0 /R1)
Time frame: 6 weeks after PAE (at the time of RALP)
Assessment of Adverse Events of PAE according to CTCAE V4.03
Time frame: At the time of PAE and 6 weeks afterwards
Assessment of Adverse Events of PAE according to Clavien-Dindo classification
Time frame: At the time of PAE and 6 weeks afterwards
Assessment of Adverse Events of RALP after PAE according to CTCAE V4.03
Time frame: At the time of RALP, 6 weeks and 12 weeks later
Assessment of Adverse Events of RALP after PAE according to Clavien-Dindo classification
Time frame: At the time of RALP, 6 weeks and 12 weeks later
Change of prostate volume in MRI after PAE
Time frame: Before and 6 weeks after PAE
Change of tumor detection rate in MRI after PAE
Time frame: Before and 6 weeks after PAE
Change of tumor size in MRI after PAE
Time frame: Before and 6 weeks after PAE
Change of PIRADS classification in MRI after PAE
Time frame: Before and 6 weeks after PAE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
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RecruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominik Abt, MD principal investigator
Cantonal Hospital of St. Gallen
Livio Mordasini, MD principal investigator
Cantonal Hospital Luzerne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostatic Artery Embolization (PAE) in people with Prostate Cancer, run by Dominik Abt at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response (time frame: 6 weeks after PAE (at the time of RALP)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.