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Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride


Phase 3
18 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride


OBJECTIVES:

- Determine the efficacy of dutasteride followed by contrast-enhanced, ultrasound-guided
targeted biopsy in detecting prostate cancer.

- Determine the detection rate of prostate cancer with targeted biopsy using
contrast-enhanced ultrasound combined with dutasteride.

- Determine the efficacy of targeted biopsy using contrast-enhanced ultrasound vs
systematic biopsy in diagnosing clinically significant prostate cancer.

- Determine the reduction in post-biopsy bleeding after dutasteride in these patients.

- Determine the cost effectiveness of this regimen in these patients.

OUTLINE: This is a prospective, double-blind, placebo-controlled, randomized study. Patients
are randomized to 1 of 2 arms.

- Arm I: Patients receive oral dutasteride once daily on days 1-14.

- Arm II: Patients receive oral placebo once daily on days 1-14. On day 14, patients in
both arms undergo blood collection and contrast-enhanced (perflutren protein-type A
microspheres) transrectal ultrasound. Conventional gray-scale imaging, color Doppler
imaging, and power Doppler imaging are performed. Biopsies are then performed; first up
to 6 targeted ultrasound-guided biopsies and then up to 12 systematic biopsies.

After completion of study procedures, patients are followed at 1 day.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Suspected prostate cancer due to 1 of the following criteria:

- Prior abnormal digital rectal exam

- Elevated prostate-specific antigen (PSA) ≥ 2.6 ng/mL within the past 90 days

- PSA velocity > 0.75 ng/mL/year

- Must be planning to undergo a transrectal ultrasound with biopsy

PATIENT CHARACTERISTICS:

- Must be in adequate physical health to tolerate a prolonged transrectal examination
and biopsy

- Must not be clinically unstable, severely ill, or moribund

PRIOR CONCURRENT THERAPY:

- More than 30 days since prior biopsy of the prostate

- More than 1 week since prior acetylsalicylic acid or blood thinner

- More than 30 days since prior participation in a clinical trial involving an
investigational drug

- No prior therapy for prostate cancer

- No other concurrent 5-alpha reductase inhibitor

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Diagnostic

Outcome Measure:

Efficacy of short-term dutasteride in improving prostate cancer detection

Safety Issue:

No

Principal Investigator

Ethan J. Halpern, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kimmel Cancer Center (KCC)

Authority:

Unspecified

Study ID:

CDR0000513051

NCT ID:

NCT00398281

Start Date:

November 2006

Completion Date:

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • Prostatic Neoplasms

Name

Location
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107