PLFT PLFT –– TUMTTUMT

Alternative zur TURP ? Alternative zur TURP ?

U. W. Tunn

AK – BPH

12. Nov. 2005

Münster

0 20 40 60 80 100

0

10

20

30

50

60

70

80

Bladder neck

Catheter

Heating characteristics of the antenna vs temperatures in vivo

mm

mm

Prostate

Balloon

Sphincter

65.3 C 61.7 C 52.3 C 44.5 C 41.0C62.0 C 59.6 C 53.4 C 47.3 C 43.5 C58.6 C 55.9 C 50.5 C 44.8 C 41.5 C47.1 C 46.9 C 45.4 C 42.5 C 40.8 C

100%75%50%

25%

125%

10%

Cell kill modelling in clinical useCell kill modelling in clinical use

MRI after PLFT-TUMT

MRI Specimen MRI Specimen NecrosisNecrosis--PADPAD

Prostate base

-15 mm

-30 mm

Die TURP Die TURP gilt als Standardverfahren, gilt als Standardverfahren, mit dem andere Methoden mit dem andere Methoden verglichen werden müssen.verglichen werden müssen.

Leitlinien der Deutschen UrologenLeitlinien der Deutschen Urologen

GoldGold--StandardStandard

PLFT – TUMT vs.

2005n = 1545y FUWAGRELL L. et al

2004n = 1543y FUWAGRELL L. et al

2005n = 2841y FUGRAVAS S. et al

OutcomeOutcome (LUTS (LUTS /LQ /Morbidit/LQ /Morbiditäät)t)

Wirtschaftlichkeit (Kosten)Wirtschaftlichkeit (Kosten)

EffektivitätsanalyseEffektivitätsanalyse

17.3 7.514.97.7Qmax

7.2 20.1 7.520.9IPSS

1yBaseline1yBaseline

TURPPLFT –TUMTMean

GRAVAS et al. J. Urol. 175, 1002 2005

PLFT – TUMT vs.

Pooled data three studies

Baseline 24 months

PLFT 20,9 7,5 IPSS

TURP 20,1 7,2

PLFT 4,3 1,3 Bother-score

TURP 4,2 1,4

PLFT 7,7 14,9 Qmax (ml/s)

TURP 7,5 17,3

PLFT 51,9 35 Prostate volume (ml)

TURP 53,7 24

PLFT – TUMT vs.

GRAVAS et al. J. Urol. 175, 1002 2005

PooledPooled data data threethree studies PLFTstudies PLFTn=180,n=180, 12 12 monthsmonths followfollow--upup

34 ± 1552 ± 18Prostate volume (ml)

51 ± 2574 ± 29Voiding pressure (cm H2O)

16.1 ± 9.37.7 ± 2.7Qmax (ml/s)

1.2 ± 1.24.2 ± 0.9Bother score

6.4 ± 5.720.9 ± 5.1IPSS

12 months Pre treatmentParameter

PLFT PLFT vsvs TURPTURP

IPSS

0,0

5,0

10,0

15,0

20,0

25,0

30,0

PLFTTURP

Baseline 3 m 6 m 12 m 24 m

PLFT PLFT vsvs TURPTURP

Botherscore

0,0

1,0

2,0

3,0

4,0

5,0

6,0

PLFTTURP

Baseline 3 m 6 m 12 m 24 m

Adverse Events* in the PLFT group possibly/probably related to the treatment

Total n % Impotence 5 6 % PSA increase 3 4 % Haematuria 2 2 % Bladder calculus 1 1 % Micturition frequency 1 1 % Micturition urgency 1 1 % Urinary incontinence 1 1 % Urethral disorder 1 1 %

*) ongoing events at 12 month follow-up and/or new events during the period 12-24 months

Adverse Events* in the TURP group possibly/probably related to the treatment

Total n % Impotence 4 10 % Micturition urgency 4 10 % Urethral disorder 3 8 % Urinary incontinence 2 5 % Urinary tract infection 1 3 % Back pain 1 3 % Myelitis 1 3 % *) ongoing events at 12 month follow-up and/or new events during the period 12-24 months

PLFT vs TURPPLFT vs TURP

* Responders:

• IPSS ≤ 7, or IPSS decreases ≥ 50% compared to baseline

and/or

• Qmax ≥ 15 ml/s, or increase ≥ 50% compared to baseline

Responders* at 24 months

PLFT 82%TURP 92%

FIVE-YEARS FOLLOW-UP OF PROSTALUND FEEDBACK MICROWAVE THERMOTHERAPY VS. TURP FOR CLINICAL BPH: A PROSPECTIVE

RANDOMIZED MULTICENTRE STUDY

Participating Investigators

M.D. Lennart WagrellAkademiska sjukhuset, Uppsala, SwedenM.D. Sonny SchelinSpecialistläkargruppen, Kalmar, SwedenProf. Anders MattiassonUniversitetssjukhuset, Lund, SwedenM.D. Bo MagnussonKristianstadkliniken, SwedenM.D. Moddy SchainKristianstadkliniken, SwedenM.D. Håkan AgeheimHudiksvalls sjukhus, Sweden

M.D. Jonas RichthoffLjungby Lasarett, SwedenProf. Jørgen NordlingKAS Herlev, DenmarkM.D. Jens DuelundFrederiksberg sjukhus, DenmarkM.D. Kurt KrøyerFrederiksberg sjukhus, DenmarkM.D. Emmett BoyleGenito Urinary Surgeons, USAM.D. Thayne LarsonMayo Clinic, Scottsdale, USA

Study protocol

154 patients randomized to PLFT or TURP (ratio 2:1)

Inclusion criteria: IPSS ≥ 13Peak flow (Qmax) < 13 ml/sInformed consent

FIVE-YEARS FOLLOW-UP OF PROSTALUND FEEDBACK MICROWAVE THERMOTHERAPY VS. TURP FOR CLINICAL BPH: A PROSPECTIVE

RANDOMIZED MULTICENTRE STUDY

0

5

10

15

20

25

0 12 24 36 48 60

Months after treatment

Sym

ptom

Sco

re -

IPSS Severe symptoms

Moderate symptoms

Mild symptoms

PLFT-TUMT

TURP

Results

FIVE-YEARS FOLLOW-UP OF PROSTALUND FEEDBACK MICROWAVE THERMOTHERAPY VS. TURP FOR CLINICAL BPH: A PROSPECTIVE

RANDOMIZED MULTICENTRE STUDY

0

1

2

3

4

5

0 12 24 36 48 60

Months after treatment

Bot

her S

core

0

5

10

15

0 12 24 36 48 60

Months after treatmentQ

max

(ml)

PLFT-TUMT

TURP

PLFT-TUMT

TURP

Prostate volume and residual urine

515 years

94BaselineTURP

705 years

106BaselinePLFT

Residual urine volume (ml)

43%5 years

51%12 monthsTURP

10%5 years

30%12 monthsPLFT

Reduction in prostate volume

Proportions of responders at 2 to 5 years follow-up

87.2%12.8%%

3934**5nTUR-P

77.5%22.5%%

8062**18nPLFT

TotalsResponders*Non-responders*Treatment

87.2%12.8%%

3934**5nTURP

77.5%22.5%%

8062**18nPLFT

TotalsResponders*Non-

responders*Treatment

* Responder definition: A patient at 5 years’ visit, or latest visit according to principles of LOCF (Last Observation Carried Forward) with an IPSS of 7 or less and/or a Qmax of 15 ml/sec or more, or a 50% or greater improvement in IPSS or Qmax from baseline.

** No statistically significant difference between the groups, p=0.32229

Disposition of patients in the study

2.2%10.9%4.3%8.7%73.9%TURP

1.0%22.0%10.0%5.0%62.0%CoreTherm

OtherPatient's

requestTreatment

FailureAdverse

event

Remaining in study

@ 5 yearsTreatment

Reason for withdrawalNumber of patients

Kind of additional treatment needed for all patients with treatment failure

61**0100TUR-P

12,52*1115PLFT

%OtherDHT

inhibitorAlpha-blockerTURVPTURPTreatment

* Additional treatment type unknown.

** Patient operated for urethral stricture

Serious Adverse Events (SAE) –Possibly / probably related to treatment

During the period 0-60 months:

PLFT 5 % (2 haematuria, 1 urinaryretention, 1 prostaticdisorder, 1 bladder calculus)

TURP 17% (4 hematuria, 1 urinary tractinfection, 1 TURP syndrome,1 urosepsis,1 clot retention)

Frequent mild to moderate adverse events

During the first year post treatment temporary mild to moderate adverse events occurred more often with PLFT-TUMT than with TURP. The following AE occurred the first year post treatment:

Urgency - more common in the PLFT-TUMT groupUrinary retention,UTI,Hematuria

- more common in the TURP group

During the period 1 to 5 years post treatment the frequency of mild to moderate adverse events wereIn thePLFT-TUMT group 19 % In theTURP group 30 %

FIVE-YEARS FOLLOW-UP OF PROSTALUND FEEDBACK MICROWAVE THERMOTHERAPY VS. TURP FOR CLINICAL BPH: A PROSPECTIVE

RANDOMIZED MULTICENTRE STUDY

Conclusion5 year follow-up shows a comparable efficacy in both treatment groups. Long-term follow-up of adverse events during the post-treatment period up to 5 years reveal no major safety concerns for PLFT-TUMT.

Ambulantln-Hospital

5.3 d

TUMTTURP

DE LA ROSETTE et al. BJU 92, 713-718 2003

AggregatedAggregated costcost per per casecase€€

TURPPLFT-TUMT

32641924 Total cost (1y)

2980 1716 Direct cost of treatment

Kobelt G. et al. BJU 93, 534 - 548 2004

AggregatedAggregated costcost per per casecase

TURPTUMT

7800 (7118-8482)

5300 (4692-5908)

Total cost

321(22-620)

1026 (443-1609)

Cost of re-treatment

6560 (5992-7128)

3450 (3444-3456)

Direct cost of treatment

DE LA ROSETTE et al. BJU 92, 713-718 2003

0,45 € = 1 NLG

RetreatmentRetreatment HEHE--TUMT TUMT vs.TURPvs.TURP

TUMT

TURP

DE LA ROSETTE et al. BJU 92, 713-718 2003

DE LA ROSETTE et al. BJU 92, 713-718 2003 Kobelt G. et al. BJU 93, 543 – 548 2004

PLFT – TUMT vs.

- similar outcome after 3 and 5 years

- costs remain lower for PLFT thanfor TURP, despite more re-

interventions

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