Prostatic Artery Embolization in Advanced Prostate Cancer

Sponsor
Dominik Abt (Other)
Overall Status
Recruiting
CT.gov ID
NCT03457805
Collaborator
(none)
20
1
1
41
0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Prostatic Artery Embolization
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prostatic Artery Embolization (PAE) in Patients With Advanced Prostate Cancer: A Pilot Study.
Actual Study Start Date :
Mar 2, 2018
Anticipated Primary Completion Date :
Jul 2, 2021
Anticipated Study Completion Date :
Aug 2, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Prostatic Artery Embolization (PAE)

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).

Outcome Measures

Primary Outcome Measures

  1. Reduction of Lower Urinary Tract Symptoms [Baseline and 12 weeks]

    Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))

Secondary Outcome Measures

  1. Reduction of Lower Urinary Tract Symptoms [Baseline and 6 weeks]

    Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))

  2. Reduction of Lower Urinary Tract Symptoms [Baseline and 6 months]

    Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))

  3. Reduction of Lower Urinary Tract Symptoms [Baseline and 12 months]

    Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))

  4. Occurrence of macroscopic hematuria [From time of PAE to study completion (1 year)]

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

  5. Reduction of Prostate symptoms [baseline and 6 weeks]

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

  6. Reduction of Prostate symptoms [baseline and 12 weeks]

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

  7. Reduction of Prostate symptoms [baseline and 6 months]

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

  8. Reduction of Prostate symptoms [baseline and 12 months]

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

  9. Occurrence of urinary incontinence [6 week after PAE]

    Assessment of ICS-SF questionnaire

  10. Occurrence of urinary incontinence [12 week after PAE]

    Assessment of ICS-SF questionnaire

  11. Occurrence of urinary incontinence [6 months after PAE]

    Assessment of ICS-SF questionnaire

  12. Occurrence of urinary incontinence [12 months after PAE]

    Assessment of ICS-SF questionnaire

  13. Changes of free urinary flow rate [Baseline and 6 weeks]

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

  14. Changes of free urinary flow rate [Baseline and 12 weeks]

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

  15. Changes of free urinary flow rate [Baseline and 6 months]

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

  16. Changes of free urinary flow rate [Baseline and 12 months]

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

  17. Changes of post void residual urine [Baseline and 6 weeks]

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

  18. Changes of post void residual urine [Baseline and 12 weeks]

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

  19. Changes of post void residual urine [Baseline and 6 months]

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

  20. Changes of post void residual urine [Baseline and 12 months]

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

  21. Rate of local reinterventions [During 1 year study period]

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

  22. Intraoperative Adverse Events [While PAE is performed (intra-operatively)]

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

  23. Adverse Events [6 weeks after PAE]

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

  24. Adverse Events [12 weeks after PAE]

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

  25. Adverse Events [6 months after PAE]

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

  26. Adverse Events [12 months after PAE]

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

  27. Feasibility of PAE [While PAE is performed (intra-operatively)]

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

  28. Estimation of tumor burden [Baseline and 24h after PAE]

    Changes of Prostate Specific Antigen

  29. Estimation of tumor burden [Baseline and 6 weeks after PAE]

    Changes of Prostate Specific Antigen

  30. Estimation of tumor burden [Baseline and 12 weeks after PAE]

    Changes of Prostate Specific Antigen

  31. Estimation of tumor burden [Baseline and 6 months after PAE]

    Changes of Prostate Specific Antigen

  32. Estimation of tumor burden [Baseline and 12 months after PAE]

    Changes of Prostate Specific Antigen

  33. Estimation of tumor volume [Baseline and 12 weeks after PAE]

    Change of tumor volume calculated by magnetic resonance imaging

  34. Prostate volume [Baseline and 12 weeks after PAE]

    Change of prostate volume calculated by magnetic resonance imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cantonal Hospital St. Gallen St. Gallen Saint Gallen Switzerland 9007

Sponsors and Collaborators

  • Dominik Abt

Investigators

  • Principal Investigator: Dominik Abt, MD, St. Gallen Cantonal Hospital, Dept. of Urology, Rorschacherstrasse 95, 9007 St. Gallen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dominik Abt, Dr. med., Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT03457805
Other Study ID Numbers:
  • CTU17/028
First Posted:
Mar 8, 2018
Last Update Posted:
Jan 26, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dominik Abt, Dr. med., Cantonal Hospital of St. Gallen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2021