Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer
Brief Summary: This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.


Options:
A: Inclusion Criteria:

* Diagnosis of category IIIa of IIIb chronic prostatitis
* NIH-CPSI (National Institute of Health Chronic Prostatitis Symptom Index) score ≥ 15

Exclusion Criteria:

* Urinary tract infection or uropathogen within the past 12 months
* Serious medical problems
* NIH consensus exclusion criteria13 (presence of active urethritis, urogenital cancer, urinary tract disease, functionally significant urethral stricture, neurological disease affecting the bladder, etc.)
* Drug therapy that might affect lower urinary tract functions within the past 3 months
B: Inclusion Criteria:

* Participant has signed and dated the appropriate Informed Consent document.
* Participant must have had symptoms of discomfort or pain in the pelvic region for at least a three (3) month period within the last six (6) months.

Exclusion Criteria:

* Participant has continued evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 and ≤ 100,000 CFU/ml in mid-stream urine (VB2), as demonstrated by repeat culture obtained no less than seven (7) days post antibiotic treatment.
* Participant has a calculated creatinine clearance of \<60 mL/min.
* Participant has a platelet count \<100,000/mm3.
* Participant is allergic to antiepileptic/antiseizure medications.
* Participant has a known allergy or sensitivity to pregabalin (Lyrica®).
* Participant is taking thiazolidinedione antidiabetic agents (i.e. rosiglitazone and pioglitazone).
* Participant has New York Heart Association Class III or IV congestive heart failure.
* Participant has a history of thrombocytopenia, or a bleeding diathesis.
* Participant has a history of prostate, bladder or urethral cancer.
* Participant has a history of alcohol abuse.
* Participant has inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome).
* Participant has undergone pelvic radiation or systemic chemotherapy.
* Participant has undergone intravesical chemotherapy.
* Participant has been treated with intravesical BCG.
* Participant has unilateral orchalgia without other pelvic symptoms.
* Participant has an active urethral stricture.
* Participant has a neurological disease or disorder affecting the bladder.
* Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
C: Inclusion Criteria:

* Participant has signed and dated the appropriate Informed Consent document.
* Participant is male.
* Participant is at least 18 years of age.
* Participant has had symptoms of discomfort or pain in the pelvic region for at least a six-week interval at the time of presentation.
* Symptoms bothersome enough to prompt a physician visit have been present for two years or less.

Exclusion Criteria:

* Participant has evidence of facultative Gram negative or enterococcus with a value of greater than or equal to 1000 colony forming units (CFU) /ml in mid-stream urine (VB2).
* Participant has previously received alfuzosin (Uroxatral®), tamsulosin hydrochloride (Flomax®), doxazosin mesylate (Cardura®), terazosin hydrochloride (HCL) (Hytrin®), or other alpha-adrenergic receptor blockers for symptoms of CP/CPPS or within the past two years for any other reason.
* Participant has a history of prostate, penile, testicular, bladder, or urethral cancer or has undergone pelvic radiation, systemic chemotherapy, or intravesical chemotherapy.
* Participant has a history of moderate or severe hepatic impairment, severe renal sufficiency, severe or unstable cardiovascular (i.e. prolonged QT), respiratory, hematological, endocrinological, neurological or other somatic disorders.
* Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture, or neurological disease or disorder affecting the bladder.
* Participant has uninvestigated, significant hematuria.
* Participant has undergone transurethral prostatectomy (TURP), transurethral incision of the prostate (TUIP), transurethral Incision or Resection of the Bladder Neck (TUIBN), transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation of the prostate, open prostatectomy or any other prostate surgery or treatment such as cryotherapy or thermal therapy.
* Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
* Participant is currently taking exclusionary medications such as potent CYP3A4 inhibitors (i.e. ketoconazole, itraconazole, or ritonavir) or erythromycin.
D: Inclusion criteria:

* Informed consent to participate in study.
* Have had a single negative prostate biopsy within 6 months prior to enrollment in study.
* Have a PSA (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or a PSA between 3.0 and 10 if over age 60.
* Ability and will to participate in study for 4 years.

Exclusion criteria:

* More than one previous negative prostate biopsy.
* History of prostate cancer.
* Previous prostate surgery.
* Inability to urinate requiring the need of a catheter during the previous 2 years.
* Any condition (other than benign prostatic hypertrophy) which may result in urinary symptoms or changes in urine flow rate.
* Cancer within previous 5 years (other than basal or squamous cell cancers of the skin).
* Any unstable serious medical condition.
* Use within the past 12 months of finasteride (Proscar or Propecia), dutasteride (Avodart), testosterone, or drugs that can block the action of male hormones.

Answer: D