Patient has provided signed informed consent 
Patient is aged greater than or equal to 40 and less than or equal to 89 years of age 
Patient has a prostate size between 90g and 200g, as determined by MRI 
Patient has experienced lower urinary tract symptoms (LUTS) for at least 6 months prior to study enrollment 
Patient has an IPSS score of at least 13 at baseline 
Patient is either: refractory to medical treatment, contraindicated to medical treatment, OR refuses medical treatment 
Patient either: refuses surgical treatment OR is contraindicated for surgical treatment 
Patient meets ONE of the following criteria: baseline PSA < 4.0ng/mL (no prostate biopsy required) OR baseline PSA >/= 4 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy) within the prior 12 months 

NCT02396420_inc_T3
Value
greater than or equal to 40
NCT02396420_inc_T4
Person
aged
NCT02396420_inc_T5
Value
less than or equal to 89 years
NCT02396420_inc_T7
Scope
greater than or equal to 40 and less than or equal to 89 years
NCT02396420_inc_T8
Value
between 90g and 200g
NCT02396420_inc_T9
Measurement
prostate size
NCT02396420_inc_T10
Procedure
MRI
NCT02396420_inc_T11
Condition
lower urinary tract symptoms (LUTS)
NCT02396420_inc_T12
Temporal
at least 6 months prior to study enrollment
NCT02396420_inc_T13
Reference_point
study enrollment
NCT02396420_inc_T14
Measurement
IPSS score
NCT02396420_inc_T15
Value
at least 13
NCT02396420_inc_T16
Temporal
at baseline
NCT02396420_inc_T17
Reference_point
baseline
NCT02396420_inc_T18
Condition
refractory to medical treatment
NCT02396420_inc_T19
Condition
contraindicated to medical treatment
NCT02396420_inc_T20
Condition
refuses medical treatment
NCT02396420_inc_T21
Condition
refuses surgical treatment
NCT02396420_inc_T22
Condition
contraindicated for surgical treatment
NCT02396420_inc_T23
Measurement
PSA
NCT02396420_inc_T24
Temporal
baseline
NCT02396420_inc_T25
Value
< 4.0ng/mL
NCT02396420_inc_T26
Measurement
PSA
NCT02396420_inc_T27
Temporal
baseline
NCT02396420_inc_T28
Value
>/= 4 ng/mL
NCT02396420_inc_T29
Measurement
prostate biopsy
NCT02396420_inc_T30
Value
negative
NCT02396420_inc_T31
Multiplier
minimum 12
NCT02396420_inc_T32
Procedure
core biopsy
NCT02396420_inc_T33
Temporal
within the prior 12 months
NCT02396420_inc_T34
Scope
baseline PSA < 4.0ng/mL (no prostate biopsy required) OR baseline PSA >/= 4 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy)
NCT02396420_inc_T35
Scope
baseline PSA >/= 4 ng/mL AND a negative prostate biops
NCT02396420_inc_T1
Observation
signed informed consent