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Prostate CancerNCT03457805

Prostatic Artery Embolization in Advanced Prostate Cancer

A study testing Prostatic Artery Embolization in people with Prostate Cancer and Bladder Outlet Obstruction, run by Dominik Abt at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Any age, men only
Conditions the study is for
Prostate Cancer, Bladder Outlet Obstruction
What is being tested?
Prostatic Artery Embolization
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSwitzerland
Study dates
2 Mar 2018to 2 Aug 2021
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 Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Dominik Abt, MD contact

+41714941418

dominik.abt@kssg.ch

Switzerland1 site, 1 recruiting

  • Cantonal Hospital St. Gallen

    Sankt Gallen, Canton of St. Gallen, 9007

    Dominik Abt, MD, +41714941416, dominik.abt@kssg.ch

    Gautier Müllhaupt, MD, +41714941416, Gautier.muellhaupt@kssg.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Prostatic Artery Embolization (PAE) in Patients With Advanced Prostate Cancer: A Pilot Study.

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

Read the 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.

Being tested
Prostatic Artery Embolization
Keywords
prostate cancer, prostate, embolization, minimally invasive, cytoreductive therapy
Medical subject headings
Prostatic Neoplasms, Urinary Bladder Neck Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prostatic Artery EmbolizationDevice

    PAE is performed under local anesthesia using commercially available and approved microspheres (study is not limited to a specific manufacturer or product).

Study groups in NCT03457805
Study groupRoleWhat they receive
Prostatic Artery Embolization (PAE)OtherPAE performed under local anesthesia using officially approved microspheres.
Receives: Device: Prostatic Artery Embolization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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))

    Measured: Baseline and 12 weeks

Secondary outcomes (34)

  1. 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))

    Measured: Baseline and 6 weeks

  2. 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))

    Measured: Baseline and 6 months

  3. 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))

    Measured: Baseline and 12 months

  4. Occurrence of macroscopic hematuria

    Assessment of occurrence of hematuria according to CTCAE v.4.03 classification

    Measured: From time of PAE to study completion (1 year)

  5. Reduction of Prostate symptoms

    Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))

    Measured: baseline and 6 weeks

  6. Reduction of Prostate symptoms

    Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))

    Measured: baseline and 12 weeks

  7. Reduction of Prostate symptoms

    Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))

    Measured: baseline and 6 months

  8. Reduction of Prostate symptoms

    Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))

    Measured: baseline and 12 months

  9. Occurrence of urinary incontinence

    Assessment of ICS-SF questionnaire

    Measured: 6 week after PAE

  10. Occurrence of urinary incontinence

    Assessment of ICS-SF questionnaire

    Measured: 12 week after PAE

  11. Occurrence of urinary incontinence

    Assessment of ICS-SF questionnaire

    Measured: 6 months after PAE

  12. Occurrence of urinary incontinence

    Assessment of ICS-SF questionnaire

    Measured: 12 months after PAE

  13. Changes of free urinary flow rate

    Measurement of urinary stream (mL/s) by urinary flow rate measurement

    Measured: Baseline and 6 weeks

  14. Changes of free urinary flow rate

    Measurement of urinary stream (mL/s) by urinary flow rate measurement

    Measured: Baseline and 12 weeks

  15. Changes of free urinary flow rate

    Measurement of urinary stream (mL/s) by urinary flow rate measurement

    Measured: Baseline and 6 months

  16. Changes of free urinary flow rate

    Measurement of urinary stream (mL/s) by urinary flow rate measurement

    Measured: Baseline and 12 months

  17. Changes of post void residual urine

    Measurement of post void residual urine (mL) by transabdominal ultrasound

    Measured: Baseline and 6 weeks

  18. Changes of post void residual urine

    Measurement of post void residual urine (mL) by transabdominal ultrasound

    Measured: Baseline and 12 weeks

  19. Changes of post void residual urine

    Measurement of post void residual urine (mL) by transabdominal ultrasound

    Measured: Baseline and 6 months

  20. Changes of post void residual urine

    Measurement of post void residual urine (mL) by transabdominal ultrasound

    Measured: Baseline and 12 months

  21. Rate of local reinterventions

    Assessment of number and type of reinterventions for prostate and bladder problems

    Measured: During 1 year study period

  22. Intraoperative Adverse Events

    Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE

    Measured: While PAE is performed (intra-operatively)

  23. Adverse Events

    Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE

    Measured: 6 weeks after PAE

  24. Adverse Events

    Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE

    Measured: 12 weeks after PAE

  25. Adverse Events

    Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE

    Measured: 6 months after PAE

  26. Adverse Events

    Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE

    Measured: 12 months after PAE

  27. Feasibility of PAE

    Possibility of successful completion of PAE in the study cohort defined by compete stasis of blood flow in the prostate

    Measured: While PAE is performed (intra-operatively)

  28. Estimation of tumor burden

    Changes of Prostate Specific Antigen

    Measured: Baseline and 24h after PAE

  29. Estimation of tumor burden

    Changes of Prostate Specific Antigen

    Measured: Baseline and 6 weeks after PAE

  30. Estimation of tumor burden

    Changes of Prostate Specific Antigen

    Measured: Baseline and 12 weeks after PAE

  31. Estimation of tumor burden

    Changes of Prostate Specific Antigen

    Measured: Baseline and 6 months after PAE

  32. Estimation of tumor burden

    Changes of Prostate Specific Antigen

    Measured: Baseline and 12 months after PAE

  33. Estimation of tumor volume

    Change of tumor volume calculated by magnetic resonance imaging

    Measured: Baseline and 12 weeks after PAE

  34. Prostate volume

    Change of prostate volume calculated by magnetic resonance imaging

    Measured: Baseline and 12 weeks after PAE

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2018
  2. Study start2 Mar 2018
  3. Primary completion2 Jul 2021 (estimated)
  4. Study completion2 Aug 2021 (estimated)

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03457805
Sponsor's protocol ID
CTU17/028
Status last verified
Jan 2021
First submitted
22 Feb 2018
Last updated
26 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Decision will be made individually up on request and based on approval by our local ethics committee.

Publications

  • Burkhardt O, Abt D, Hechelhammer L, Kim O, Omlin A, Schmid HP, Engeler D, Zumstein V, Mullhaupt G. Prostatic Artery Embolization in Patients with Advanced Prostate Cancer: A Prospective Single Center Pilot Study. Cardiovasc Intervent Radiol. 2024 Jun;47(6):771-782. doi: 10.1007/s00270-024-03679-z. Epub 2024 Feb 28.

    PubMed 38416176

Questions about this trial

What is this clinical trial studying?

A study testing Prostatic Artery Embolization in people with Prostate Cancer and Bladder Outlet Obstruction, run by Dominik Abt at 1 site 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: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dominik Abt, MD (+41714941418, dominik.abt@kssg.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of Lower Urinary Tract Symptoms (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03457805, which also lists 1 linked publication.

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 26 Jan 2021.

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Clinical Trial NCT03457805 | AzTrials