Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004120

Trial Description

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Title

A Prospective Multicenter Randomized Study Comparing Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hyperplasia (The Goliath Study)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The study will compare procedural and post procedural outcomes for photoselective
vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP). The
study requires use of the CE marked GreenLight XPS™ Laser System (GreenLight XPS) or a CE
marked monopolar or bipolar loop TURP system for the treatment of benign prostatic
hyperplasia (BPH). The purpose of the study is to demonstrate that PVP is not inferior to
TURP.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004120
  •   2013/01/09
  •   2010/10/08
  •   no
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Secondary IDs

  •   NCT01218672  (ClinicalTrials.gov)
  •   PE1006  (American Medical Systems)
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Health Condition or Problem studied

  •   Benign Prostatic Hyperplasia
  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   Device: GreenLight XPS vs. TURP
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
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Primary Outcome

- BPH symptoms compared to TURP symptoms a 6 months post procedure; time frame: 6 months; To demonstrate that BPH symptoms after PVP are not worse when compared to TURP at 6 months post procedure measured via international prostate symptom score (IPSS) for the treatment of BPH.

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Secondary Outcome

- To compare the functional status of PVP and TURP via maximum urinary flow rate (Qmax); time frame: 6 months; Maximum urinary flow rate (Qmax) measured at baseline and a the 6-month follow-up visits
- To compare the complication-free rate of PVP and TURP; time frame: 6 months; A that is subject free of device and procedure-related complications. A complication is defined as a device or procedure-related adverse event meeting at least 1 of the following criteria:
Required a prolonged or secondary hospitalization
Required surgical or invasive intervention (eg, breaking of the skin) and excuding urinary catheterization for transient retention lasting less than 7 days and/or IV medications related to anesthesia
Perforation of tissue or a physiologic structure
- To compare prostate volume post treatment for PVP and TURP; time frame: 6 months; Prostate volume (vis TRUS) taken at baseline and 6 month follow-up visit.
- To compare immediate post treatment outcomes of PVP and TURP; time frame: 3 weeks; SF-36 Acute form collected at 3-week visit (2 composite score and 6 subscores). Length of stay calculated as the difference from entering the recovery room date/time to discharge date/time
- To compare health status of PVP and TURP; time frame: 2 years; The IPSS, BII, OABq, SF-36 Acute and EQ-5D instruments will be scored per instructions for each instrument as collected at baseline and follow-up visit case report forms.
- To compare tolerability of PVP and TURP; time frame: 2 Years; The IIEF and ICIQ-SF instruments will be scored per instructions for each instrument as collected at baseline and the follow-up visit case report forms.
- To compare subject satisfaction of PVP and TURP; time frame: 2 Years; Subject responses to satisfaction with treatment as collected on follow-up visits.
- To compare rate of retreatment of PVP and TURP; time frame: 2 Years; Subject experiencing a retreatment (removal of tissue via TUPR, PVP, or other intervention) for obstruction after the initial procedure was required

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Countries of Recruitment

  •   Austria
  •   Belgium
  •   France
  •   Germany
  •   Italy
  •   Netherlands
  •   Spain
  •   Switzerland
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2011/04/30
  •   290
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   40   Years
  •   80   Years
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Additional Inclusion Criteria

Inclusion criteria:

- Subject has provided informed consent and agrees to attend all study visits

- Subject has diagnosis of lower urinary tract symptoms due to benign prostatic
enlargement causing bladder outlet obstruction

- Subject is willing to be randomized

- Subject is able to complete self-administered questionnaires

- Clinical investigator has documented in the subject's medical record that in his/her
judgment the subject is a surgical candidate for either the PVP or the TURP procedure
and may be randomized into either arm

- Subject is 40 to 80 years of age

- Subject has an IPSS score greater than or equal to 12 measured at the baseline visit

- Subject has medical record documentation of a maximum urinary flow rate (Qmax) less
than 15ml/s (If uroflow testing documentation is available within 90 days prior to
the informed consent date, and the sample is greater than or equal to 150ml, and the
Qmax is less than 15ml/s it may be used for the inclusion/exclusion criteria)

- Subject has medical record documentation of a prostate volume of less than or equal
to 100g by transrectal ultrasound (TRUS) (If TRUS testing documentation is available
from less than 180 days prior to the informed consent date and the prostate volume is
less than or equal to 100g, it may be used for the inclusion/exclusion criteria)

- Subject is classified as American Society of Anesthesiologists (ASA) I, II or III

- Subject has a serum creatinine that is within the normal range for the laboratory at
the study center (or documentation of clinical insignificance in the subject's
medical record by the investigator if outside the normal range) and measured less
than or equal to 30 days prior to the date of surgery.


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Exclusion Criteria

Exclusion criteria:

- Subject has a life expectancy of less than 2 years

- Subject is currently enrolled in, or plans to enroll in, any concurrent drug or
device study unless preapproved by the sponsor

- Subject has an active infection (eg, urinary tract infection or prostatitis)

- Subject has a diagnosis of, or has received treatment for, chronic prostatitis or
chronic pelvic pain syndrome (eg, non-bacterial chronic prostatitis)

- Subject has been diagnosed with a urethral stricture or bladder neck contracture
within the 180 days prior to the informed consent date

- Subject has been diagnosed with 2 or more urethral strictures and/or bladder neck
contractures within the 5 years prior to the informed consent date

- Subject has a diagnosis of lichen sclerosus

- Subject has a neurogenic bladder or other neurological disorder that would impact
bladder function (eg, multiple sclerosis, Parkinson's disease, spinal cord injuries)

- Subject has a diagnosis of polyneuropathy (eg, diabetic)

- Subject has history of lower urinary tract surgery (eg, TURP, laser, urinary
diversion, artificial urinary sphincter, penile prosthesis)

- Subject has diagnosis of stress urinary incontinence that requires treatment or daily
pad/device use

- Subject has a history of intermittent self catheterization

- Subject has been catheterized or has a PVR >400mls in the 14 days prior to the
surgical procedure

- Subject has current diagnosis of bladder stones

- Subject has diagnosis of prostate cancer

- Subject has a history of CIS, TaGII, TaGIII or any T1 stage bladder cancer

- Subject has damage to external urinary sphincter

- Subject has a medical contraindication for undergoing either TURP or PVP surgery (eg,
infection, coagulopathy or significant cardiac or other medical risk factors for
surgery)

- Subject has a disorder of the coagulation cascade (eg, hemophilia) or disorders that
affect platelet count or function (eg, Von Willebrand's disease) that would put the
subject at risk for intraoperative or postoperative bleeding

- Subject is unable to discontinue anticoagulant and antiplatelet therapy
preoperatively (3-5 days) except for low dose aspirin (eg, less than or equal to
100mg)

- Subject has had an acute myocardial infarction, open heart surgery or cardiac arrest
less than 180 days prior to the date of informed consent

- Subject is immunocompromised (eg, organ transplant, leukemia)

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Addresses

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    • American Medical Systems
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    • University Hospital, Basel, Switzerland
    • Alexander Bachman, Prof. Dr. med. 
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    • University Hospital, Basel, Switzerland
    • Alexander Bachman, Prof. Dr. med. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   7
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.