Clinical trials that remain open for physician and patient participation.

QUANTERRA SAW PALMETTO*PEENUTSâ*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 (H&P)
	Review lower tract symptoms and voiding score
	Review EPS and PSA

Patient Satisfaction with Treatment? Yes or No

RONALD E. WHEELER, MD
2901 N. Main
Durango, CO 81301
(970) 259-4081
or
The Prostatitis and Prostate Cancer Center
1819 Main Street, Ste. 401
Downtown Sarasota, FL 34236
(941) 957-0007
Toll Free 1-877-766-8400

E-mail: prostadoc@aol.com

~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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