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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.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Joel Nelson, MD, University of Pittsburgh Identifier:
First received: July 11, 2001
Last updated: December 1, 2015
Last verified: December 2015

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.

Condition Intervention Phase
Prostate Cancer Drug: toremifene Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Randomized Controlled Clinical Trial Of The Antiestrogen GTx-006 In Subjects With Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Joel Nelson, MD, University of Pittsburgh:

Primary Outcome Measures:
  • Percent of radical prostatectomy tissue volume (exclusive of luminal area) with high-grade prostatic intraepithelial neoplasia (HGPIN) present

Enrollment: 45
Study Start Date: April 2001
Study Completion Date: June 2009
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oral toremifene Drug: toremifene Procedure: neoadjuvant therapy
observation Procedure: conventional surgery

Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


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


  • 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


  • Creatinine less than 1.5 times ULN


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


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

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


  • Not specified


  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its identifier: NCT00020735

United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Joel Nelson, MD
National Cancer Institute (NCI)
Study Chair: Joel B. Nelson, MD University of Pittsburgh
  More Information

Responsible Party: Joel Nelson, MD, Professor and Chairman, Department of Urology, University of Pittsburgh School of Medicine; Chief, Division of Surgery, UPMC Shadyside Hospital, University of Pittsburgh Identifier: NCT00020735     History of Changes
Other Study ID Numbers: PCI-00-105
CDR0000068708 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: July 11, 2001
Last Updated: December 1, 2015

Keywords provided by Joel Nelson, MD, University of Pittsburgh:
adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on September 21, 2017