Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Prevention, Treatment	Completed	Over 18	NCI	PCI-00-105 PCI-N01-CN-75018, NCI-P01-0181, NCT00020735

Objectives

1. 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.
2. Compare the absolute and relative changes in HGPIN in patients treated with toremifene vs observation alone.
3. 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.
4. 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.
5. Compare the safety of toremifene in these patients.
6. Determine the relationships among pairs of biomarkers, biomarker changes, and outcome measures, including toxicity of toremifene and posttreatment HGPIN in these patients.
7. Determine the relationship between HGPIN or biomarker responses and antiandrogen germline CAG repeat length polymorphism in patients treated with toremifene.
8. Compare the tumor volume, margin status, and pT stage in patients treated with toremifene vs observation alone.

Entry Criteria

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

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

Patient Characteristics:

Age:

• Over 18

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Neutrophil count greater than 1,500/mm³
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

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.

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

UPMC Cancer Centers

Joel Nelson, MD, Protocol chair		Ph: 412-605-3013

Registry Information
Official Title		A Phase II Randomized Controlled Clinical Trial Of The Antiestrogen GTx-006 In Subjects With Prostate Cancer
Trial Start Date		2001-04-12
Registered in ClinicalTrials.gov		NCT00020735
Date Submitted to PDQ		2001-05-03
Information Last Verified		2005-09-08
NCI Grant/Contract Number		CA47904

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