
Clinical trials that remain open for physician and patient participation.
QUANTERRA SAW PALMETTO* PEENUTS* FLOMAX(QPF STUDY)
FORMAT: RANDOMIZED, PROSPECTIVE, OPEN LAVEL
QUALIFICATION: ADULT W/AUA SCORE >8

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THE PROSTATITIS CHALLENGE
PROSTATITIS:
Do antibiotics cure the disease or have little more than placebo effect?
QUALIFY:
No Hx. of previous treatment prior one month. Absence of medications that are bladder sensitive minimally x one month.
EXAM:
- H& P
- (+) EPS [ >
10 WBC/HPF] (Independent of Physician, if possible)
- Lower Tract Symptoms (+)/(-): See worksheet
- Voiding Score: AUA vs. IPSS
- PSA
RANDOMIZE
| SEPT |
CIPRO |
FLOXIN |
PROSTATE NUTRITION |
| 1PO BID |
500 mgm PO BID |
300 mgm PO BID |
1 PO BID |
| Two weeks |
Four weeks |
Six Weeks |
Six Weeks |
ALL PATIENTS/ALL ARMS
- Repeat evaluation
- Review lower tract symptoms and voiding score
- Patient Satisfaction with Treatment? Yes No
THE PROSTATIS CHALLENGE
PATIENT NAME:
_____________________________________________________________________
PATIENT #:
__________________________________________________________________________
PATIENT
AGE:_______________________________________________________________________
PARTICIPATING PHYSICIAN:
_________________________________________________________
SPECIALTY:
_________________________________________________________________________
SIGNIFICANT PAST MEDICAL HISTORY
DATE: __________
| CHRONIC PROSTATITIS |
YES/NO |
| DIABETES MELLITUS |
YES/NO |
| PREVIOUS HX. OF ANTIBIOTICS |
YES/NO |
| HX. OF EPIDIDYMITIS |
YES/NO |
| HX. OF EPIDIDYMO-ORCHITIS |
YES/NO |
| PSA (PRE-STUDY) |
DATE: __________ |
PSA (POST-STUDY) |
DATE: __________ |
| AUA# (PRE-STUDY) |
DATE: __________ |
AUA#
(POST-STUDY) |
DATE: __________ |
| EPS (PRE-STUDY) |
DATE: __________ |
EPS (POST-STUDY) |
DATE: __________ |
LOWER TRACT SYMPTOMS:
|
|
DATE:
__________ |
DATE: __________ |
| PERINEUM PAIN |
YES/NO |
YES/NO |
| INGUINAL DISCOMFORT/PAIN |
YES/NO |
YES/NO |
| LOWER ABDOMINAL DISCOMFORT/PAIN |
YES/NO |
YES/NO |
| SCROTAL DISCOMFORT/PAIN (INCLUDING TESTICULAR) |
YES/NO |
YES/NO |
| PENILE DISCOMFORT/PAIN |
YES/NO |
YES/NO |
| EJACULATORY DISCOMFORT/PAIN |
YES/NO |
YES/NO |
| DYSURIA (PAIN/STINGING ON URINATION) |
YES/NO |
YES/NO |
| BURNING ON URINATION |
YES/NO |
YES/NO |
| HEMATURIA (MICROSCOPIC) |
YES/NO |
YES/NO |
| HEMATURIA (GROSS) |
YES/NO |
YES/NO |
| BLOOD IN EJACULATE (PER PATIENT) |
YES/NO |
YES/NO |
| DECREASED SEXUAL PERFORMANCE (PER
PATIENT) |
YES/NO |
YES/NO |
ARMS OF TREATMENT:
| SEPTRA DS ~ |
1PO
BID X 2 WEEKS |
| FLOXIN ~ |
300 MGM PO BID X 6 WEEKS |
| CIPRO |
500 MGM PO BID X 4 WEEKS |
| PROSTATE NUTRITION ~ |
1 PO BID X 6 WEEKS |
|
|
| RANDOMIZATION: |
CIPRO
(1) |
|
FLOXIN
(2) |
|
PROSTATE NUTRITION (3) |
|
SEPTRA DS (4)
|
Neoadjuvant organ confined prostate cancer trial. SCHERING STUDY
- Neoadjuvant treatment improves outcome
- Potency can be preserved
- Cost effective regimen
- LHRH shots may not be needed

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|