Ciprofloxacin Compared to Placebo in Diagnosing Prostate Cancer in Patients Undergoing Prostate Biopsy

Wake Forest University (WFU)

Status and phase: Withdrawn; Phase 2

Conditions: Prostate Cancer

Treatments: Other: laboratory biomarker analysis; Other: quality-of-life assessment; Drug: ciprofloxacin; Other: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02252978

P30CA012197 (U.S. NIH Grant/Contract)

CCCWFU 99712 (Other Identifier)

NCI-2014-01594 (Registry Identifier)

IRB00028209

Details and patient eligibility

About

This phase II trial studies ciprofloxacin compared to an inactive treatment (placebo) in diagnosing prostate cancer in patients undergoing removal of prostate cells or tissues for examination (biopsy). Ciprofloxacin is an antibiotic, a type of drug used to treat infections caused by bacteria. Giving ciprofloxacin to patients undergoing a prostate biopsy may help to lower abnormal prostate-specific antigen (PSA) levels caused by bacterial infection of the prostate gland and may or may not affect the detection rate of prostate cancer.

Full description

PRIMARY OBJECTIVES:

I. To determine the non-inferiority of the rate of detection of prostate cancer in men with decreased serum PSA values treated with placebo compared to ciprofloxacin prior to prostate biopsy.

SECONDARY OBJECTIVES:

I. To compare the change in PSA from randomization to biopsy in men treated with ciprofloxacin versus those treated with placebo.

II. To compare the rates of post-biopsy complications (including duration of hematuria, hematochezia, hematospermia, fever > 101°F, and hospital admission rates related to biopsy, sepsis, and pain) between men treated with ciprofloxacin versus those treated with placebo.

TERTIARY OBJECTIVES:

I. To determine if benign prostatic hyperplasia (BPH) or erectile dysfunction are associated with abnormal PSA or prostatic inflammation reported in the biopsy specimen.

II. To determine the correlation between change in PSA from randomization to biopsy and urinalysis pre- and post-ciprofloxacin versus placebo.

III. To determine the correlation between change in PSA and prostate massage pre- and post-ciprofloxacin versus placebo.

IV. To determine the qualitative and quantitative difference in flora (ciprofloxacin resistant organisms) obtained from rectal swab pre- and post- two week course of ciprofloxacin vs. placebo.

V. To correlate prostate symptom severity (International Prostate Symptom Score [IPSS]) with erectile function (International Index of Erectile Function [IIEF-5]) at baseline.

VI. To correlate urinary, prostate massage or rectal swab findings to pathology findings including cancer, inflammation, prostatic intra-epithelial neoplasia (PIN), atypical acinar proliferation (ASAP) or other findings at the end of the study.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive ciprofloxacin orally (PO) twice daily (BID) for 2 weeks.

ARM II: Patients receive ciprofloxacin PO BID for 2 weeks.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Abnormal serum PSA (total > 2.5 ng/ml or other clinically important biomarker parameters, including PSA velocity and density) associated with or without normal digital rectal examination
• Men who have elected to proceed with a diagnostic prostate biopsy
• Any prostate size
• Willingness and ability to give informed consent

Exclusion criteria

• History of prostate cancer
• Urine culture positive for significant urinary tract infection (UTI)
• A history of antibiotic use within one month prior to initial PSA level measurement
• Allergy to fluoroquinolones
• Currently taking imperative medications with significant drug-drug interaction with ciprofloxacin
• Compromised renal function with estimated glomerular filtration rate (GFR) of < 30 ml/min/1.73m^2

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Arm I (ciprofloxacin)

Experimental group

Description:

Patients receive ciprofloxacin PO BID for 2 weeks.

Treatment:

Other: quality-of-life assessment

Drug: ciprofloxacin

Other: laboratory biomarker analysis

Arm II (placebo)

Placebo Comparator group

Description:

Patients receive placebo PO BID for 2 weeks.

Treatment:

Other: quality-of-life assessment

Other: placebo

Other: laboratory biomarker analysis