Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00438464
First received: February 20, 2007
Last updated: April 9, 2014
Last verified: April 2014

February 20, 2007
April 9, 2014
February 2007
July 2014   (final data collection date for primary outcome measure)
Molecular marker expression based on tissue microarray (TMA) derived from the dominant tumor focus [ Time Frame: At time of prostatectomy ] [ Designated as safety issue: No ]
Data analysis will use a mixed-effects regression model, an approach appropriate for repeated measures (of continuous variables) from single participants.
Frequency of discriminating molecular marker expression in Gleason grade 3 cores
Complete list of historical versions of study NCT00438464 on ClinicalTrials.gov Archive Site
  • Molecular marker expression compared between tumor foci [ Time Frame: At time of prostatectomy ] [ Designated as safety issue: No ]
    The use of all data will be maximized by performing matched and unpaired or unmatched data analysis.
  • Frequencies with which two GGs appear in tumor foci [ Time Frame: At time of prostatectomy ] [ Designated as safety issue: No ]
    The use of all data will be maximized by performing matched and unpaired or unmatched data analysis.
  • Frequency of grade 3 and grade 4 tumor occurrence
  • Frequency of discriminating molecular signature expression in tissue microarray cores segregated by Gleason score at prostatectomy
Not Provided
Not Provided
 
Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery
A Randomized Controlled Trial Evaluating the Tissue Effects of Preoperative Finasteride Versus Placebo for Patients With Clinically Organ-Confined Prostate Cancer

This randomized phase II trial studies how well finasteride works in treating patients with stage II prostate cancer who are undergoing surgery. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using finasteride may fight prostate cancer by lowering the amount of testosterone the body makes. Giving finasteride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PRIMARY OBJECTIVES:

I. Compare the frequency of discriminating molecular marker expression in Gleason grade (GG) 3 cores, adjusted for Gleason score (GS) at prostatectomy, in patients with stage II prostate cancer treated with neoadjuvant finasteride vs placebo.

SECONDARY OBJECTIVES:

I. Compare the frequency with which grade 3 and grade 4 tumors occur in these patients.

II. Determine the frequency of discriminating molecular signature expression in tissue microarray cores segregated by GS at prostatectomy in these patients.

III. Compare GG 3-appearing areas (in tumors rated GS 6 at prostatectomy) in patients treated with finasteride vs placebo.

IV. Compare GG 3-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo.

V. Compare GG 4-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.

Patients are stratified according to study site, Gleason score (6 vs 7), and type of prostatectomy (open vs robotic/laparoscopic). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive finasteride orally (PO) once daily (QD) for 4-6 weeks, and then undergo prostatectomy.

Arm II: Patients receive placebo PO QD for 4-6 weeks, and then undergo prostatectomy.

Tumor tissue obtained at prostatectomy is used to make tissue microarrays and is analyzed by immunohistochemistry for molecular marker expression studies.

After completion of study treatment, patients are followed up for 30 days.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Adenocarcinoma of the Prostate
  • Stage II Prostate Cancer
  • Drug: finasteride
    Given PO
    Other Names:
    • Finastid
    • MK 906
    • Proscar
    • Prostide
  • Other: placebo
    Given PO
    Other Name: PLCB
  • Procedure: therapeutic conventional surgery
    Undergo prostatectomy
  • Other: laboratory biomarker analysis
    Correlative studies
  • Experimental: Arm I (finasteride)
    Patients receive finasteride PO QD for 4-6 weeks, and then undergo prostatectomy.
    Interventions:
    • Drug: finasteride
    • Procedure: therapeutic conventional surgery
    • Other: laboratory biomarker analysis
  • Placebo Comparator: Arm II (placebo)
    Patients receive placebo PO QD for 4-6 weeks, and then undergo prostatectomy.
    Interventions:
    • Other: placebo
    • Procedure: therapeutic conventional surgery
    • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
Not Provided
July 2014   (final data collection date for primary outcome measure)

Criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Clinical stage T1c or T2 (stage II)
  • Gleason score of 6 or 7 on initial biopsy
  • Prostate-specific antigen (PSA) level less than 10 ng/mL within the past 3 months
  • Candidate for and scheduled to undergo prostatectomy
  • ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100%
  • Fertile patients must use effective contraception
  • No active malignancy at any other site
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to finasteride
  • No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection; Symptomatic congestive heart failure; Unstable angina pectoris; Cardiac arrhythmia
  • No psychiatric illness or social situation that would preclude study compliance
  • More than 6 months since prior hormonal agents, including dutasteride or finasteride
  • More than 6 months since prior chemotherapy
  • More than 1 month since prior participation in another investigational study
  • No prior radiotherapy for the primary tumor
  • No concurrent dehydroepiandrosterone, phytoestrogen supplements, antiandrogen therapy, dutasteride, or other finasteride
  • No concurrent anticoagulation, except for the use of daily acetylsalicylic acid (81 mg to 325 mg)
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00438464
NCI-2009-00856, NCI-2009-00856, CDR0000653463, 2006-0614, MDA03-1-03, N01CN35159, P30CA016672
No
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Jeri Kim M.D. Anderson Cancer Center
National Cancer Institute (NCI)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP