Diagnostic Center for Disease

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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