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

NCT00438464 | Completed Phase 2 Results

• 6 other identifiers: NCI-2009-00856CDR00006534632006-0614MDA03-1-03N01CN35159P30CA016672
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Adenocarcinoma of the Prostate; Stage II Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy

  Molecular marker expression based on tissue microarray (TMA) derived from dominant tumor focus. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: vascular epithelial growth factor (VEFG), estrogen receptor beta (ERβ), androgen receptor (AR), 3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), ubiquitin-conjugating enzyme E2C (UBE2C), and Cleaved Caspase 3 (Caspase). P values are based on non-parametric Wilcoxon rank-sum test.

  At prostatectomy following maximum 6 week treatment period

• Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy

  Biomarkers using pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.

  At prostatectomy following maximum 6 week treatment period

• Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy

  Molecular marker expression compared between tumor foci using Biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.

  At prostatectomy following maximum 6 week treatment period.

• Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy

  Molecular marker expression compared between tumor foci using biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.

  At prostatectomy following maximum 6 week treatment period.

Secondary Outcomes (20)

• Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score

  Assessment following maximum 6 week treatment period and prostatectomy

• Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary)

  Assessment following maximum 6 week treatment period and prostatectomy

• Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary)

  Assessment following maximum 6 week treatment period and prostatectomy

• Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage

  Assessment following maximum 6 week treatment period and prostatectomy

• Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR)

  Assessment following maximum 6 week treatment period and prostatectomy

Study Arms (2)

Arm I (Finasteride)

EXPERIMENTAL

Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.

Drug: Finasteride; Procedure: Prostatectomy; Other: Laboratory biomarker analysis

Arm II (Placebo)

PLACEBO COMPARATOR

Placebo once daily for 4-6 weeks, then undergo prostatectomy.

Other: Placebo; Other: Laboratory biomarker analysis

Interventions

Finasteride DRUG

Given PO

Also known as: Finastid, MK 906, Proscar, Prostide

Arm I (Finasteride)

Placebo OTHER

Given PO

Also known as: PLCB

Arm II (Placebo)

Prostatectomy PROCEDURE

Undergo prostatectomy

Also known as: Radical Prostatectomy, Therapeutic conventional surgery, Simple Prostatectomy

Arm I (Finasteride)

Laboratory biomarker analysis OTHER

Correlative studies

Arm I (Finasteride); Arm II (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 * Eastern Cooperative Oncology Group (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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (8)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Audie L Murphy Veterans Affairs Hospital

San Antonio, Texas, 78209, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

University Hospital

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Finasteride; Prostatectomy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Limitations and Caveats

Predefined molecular signature could not easily distinguish GG 4 from GG 3 tumor areas in the placebo arm.

Results Point of Contact

• Title: Jeri Kim, MD / Associate Professor, Genitourinary Medical Oncology
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-2830

Study Officials

• Jeri Kim

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 22, 2007
• Study Start: February 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 9, 2016
• Results First Posted: March 9, 2016

Record last verified: 2015-06

Locations

US (8)