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Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer
This study has been completed.
Study NCT00020735   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: July 25, 2009   History of Changes

July 11, 2001
July 25, 2009
April 2001
 
Percent of radical prostatectomy tissue volume (exclusive of luminal area) with high-grade prostatic intraepithelial neoplasia (HGPIN) present [ Designated as safety issue: No ]
Percent of radical prostatectomy tissue volume (exclusive of luminal area) with high-grade prostatic intraepithelial neoplasia (HGPIN) present
Complete list of historical versions of study NCT00020735 on ClinicalTrials.gov Archive Site
 
 
 
Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer
A Phase II Randomized Controlled Clinical Trial Of The Antiestrogen GTx-006 In Subjects With Prostate Cancer

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using toremifene may fight prostate cancer by reducing the production of androgens.

PURPOSE: Randomized phase II trial to study the effectiveness of toremifene followed by radical prostatectomy in treating patients who have stage I or stage II prostate cancer.

OBJECTIVES:

  • Compare the percent of high-grade prostatic intraepithelial neoplasia (HGPIN) present in the radical prostatectomy tissue (excluding the luminal area) of patients with stage I or II adenocarcinoma of the prostate treated with toremifene vs observation alone followed by radical prostatectomy.
  • Compare the absolute and relative changes in HGPIN in patients treated with toremifene vs observation alone.
  • Compare biomarkers (including DNA ploidy and nuclear morphology; Ki67 and MIB-1 expression; bcl-2 expression; frequency of cells expressing apoptotic bodies; microvessel density; and intraprostatic testosterone, dihydrotestosterone (DHT), and estradiol) in the radical prostatectomy tissue of patients treated with toremifene vs observation alone.
  • Compare changes from baseline in serum biomarkers, particularly PSA and hormone profiles (testosterone, DHT, androstenedione, dehydroepiandrosterone, androstanediol-glucuronide, estradiol, and sex hormone binding globulin), in patients treated with toremifene vs observation alone.
  • Compare the safety of toremifene in these patients.
  • Determine the relationships among pairs of biomarkers, biomarker changes, and outcome measures, including toxicity of toremifene and posttreatment HGPIN in these patients.
  • Determine the relationship between HGPIN or biomarker responses and antiandrogen germline CAG repeat length polymorphism in patients treated with toremifene.
  • Compare the tumor volume, margin status, and pT stage in patients treated with toremifene vs observation alone.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center and baseline high-grade prostatic intraepithelial neoplasia (none vs more than 0% up to 10% vs more than 10%). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral toremifene daily for 3-6 weeks in the absence of unacceptable toxicity.
  • Arm II: Patients undergo observation alone. Patients in both arms then undergo radical prostatectomy.

PROJECTED ACCRUAL: A total of 78 patients (52 for arm I, 26 for arm II) will be accrued for this study at a rate of 6-7 patients per month.

Phase II
Interventional
Prevention, Randomized, Open Label, Active Control
Prostate Cancer
  • Drug: toremifene
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Organ-confined (cT1-2) disease (stage I or II)
    • Must be schedule to undergo radical prostatectomy
    • Prior sextant biopsy required

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • ALT and AST less than 2 times ULN
  • Alkaline phosphatase less than 2 times ULN
  • No chronic hepatitis or cirrhosis

Renal:

  • Creatinine less than 1.5 times ULN

Other:

  • No severe mental or physical illness that would preclude radical prostatectomy
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • At least 5 years since prior antiestrogen, antiandrogen, LHRH agonist, estrogen, or progestational agent

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00020735
 
CDR0000068708, PCI-00-105, PCI-N01-CN-75018, NCI-P01-0181
UPMC Cancer Centers
National Cancer Institute (NCI)
Study Chair: Joel B. Nelson, MD UPMC Cancer Centers
National Cancer Institute (NCI)
September 2005

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