Prostate Artery Embolization: State of Trials and Registries

Prostate Artery Embolization: State of
Trials and Registries
Riad Salem MD MBA FSIR
Professor of Radiology, Medicine and Surgery
Vice-Chair, Image-Guided Therapy
Chief, Vascular and Interventional Radiology
Robert H Lurie Comprehensive Cancer Center
Northwestern University
Chicago, Illinois
Riad Salem, M.D.
• Consulting Fees: BTG International, Merit,
Terumo, Boston Scientific, Merck
Current Trials
Seven active randomized/controlled studies
2 with Beadblock
1.
Lisbon, Pisco [N=80]
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1:1 PAE to sham, with crossover
2.
Fundacion Miguel Servet, Napal [N=60]
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1:1 PAE to TURP
www.clinicaltrials.gov
Current Trials
Seven active randomized/controlled studies
3 with Embosphere
3.
Merit [Multisite, N=186]
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Originally randomized 2:1 PAE to TURP
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Currently no longer randomized.
•
Active control still TURP, but cohort will be sequentially enrolled after PAE
patients are sequentially enrolled.
4.
U Hosp Zaragoza, DeGregorio [N=100]
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1:1 PAE to TURP
5.
U Miami, Bhatia [N=20]
•
PAE pre-robot assisted prostatectomy for prostate CA.
•
Nonrandomized
www.clinicaltrials.gov
Current Trials
Seven active randomized/controlled studies
2 with unknown embolic
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6.
St. Gallen Hosp Switzerland, Engeler [N=100]
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1:1 PAE to TURP
7.
Royal Victoria (Canada), Elhilali [N=73]
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1:1 PAE to greenlight laser
8.
PARTEM (RCT PAE vs med therapy)
www.clinicaltrials.gov
Current Trials
11 active open label studies 6 with Embosphere
1. Northwestern, Salem [N=50]  40 – 80 gm
2. Holy Cross Ft. Lauderdale, Rush [N=60]  >90 gm.
3. Tampa General Hosp, Davis [N=30]  >90 gm.
4. RI Hosp, Scappaticci [N= 50]  >90 gm.
5. Georgetown, Spies [N=30]  50 – 100 gm.
6. Maimonides Hosp NYC, Sobolevsky [N= 16]  pts at high risk for surgery
www.clinicaltrials.gov
Current Trials
11 active open label studies others
7. U Virginia, Haskal [N=50]  BPH with LUTS. Embozene
8. Jena Hosp, Teichgraeber [N=7]  BPH with LUTS. Embozene
9. Hosp Europeen Georges Pompidou, Sapoval [N=20]
•  acute urinary retention. BeadBlock
10. Alberta (Canada), Owen [N=15]  BPH with LUTS: OCL 503
11. U North Carolina, Isaacson [N=15]
•  80-150gm, not yet recruiting
•  Unknown embolic
www.clinicaltrials.gov
Other Trials
1 active registry
•UK ROPE study, multisite [N=300]
•PAE, TURP, open prostatectomy, laser
•Embolic: nsPVA
Completed
•Regina Qu’Appelle Saskatchewan. PI unlisted [N=13]
•BPH with LUTS
•Embolic unknown
Terminated
•U Hosp Rouen, Caremel [N= 2/25]
•Embolic: BeadBlock
www.clinicaltrials.gov
UNC PAE Study Interim Analysis
• 14 patients enrolled (80-150g PV)
• 12 have reached 3-mo f/u
• Only minor complications
Northwestern University PAE Study
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•
•
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15 patients enrolled
Insurance difficulties
Medicare recipients not obvious candidates
55 yo pts with symptoms
• New strategy hospital grant for PAE plus
2 MRIs
– 6 patients now enrolled in 2 weeks
– Long list of 180 screen failures being recalled