Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer - Full Text View

Sponsors and Collaborators:	UPMC Cancer Centers National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00020735

Purpose

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 II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control
Official Title:	A Phase II Randomized Controlled Clinical Trial Of The Antiestrogen GTx-006 In Subjects With Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Toremifene Toremifene citrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Percent of radical prostatectomy tissue volume (exclusive of luminal area) with high-grade prostatic intraepithelial neoplasia (HGPIN) present [ Designated as safety issue: No ]

Study Start Date:

April 2001

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020735

Locations

United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232

Sponsors and Collaborators

UPMC Cancer Centers

National Cancer Institute (NCI)

Investigators

Study Chair:

Joel B. Nelson, MD

UPMC Cancer Centers

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068708, PCI-00-105, PCI-N01-CN-75018, NCI-P01-0181
Study First Received:	July 11, 2001
Last Updated:	July 25, 2009
ClinicalTrials.gov Identifier:	NCT00020735 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer

Study placed in the following topic categories:

Estrogen Antagonists
Estrogens
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents

Urogenital Neoplasms
Genital Diseases, Male
Selective Estrogen Receptor Modulators
Toremifene
Hormones
Estrogen Receptor Modulators
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Urogenital Neoplasms

Genital Diseases, Male
Selective Estrogen Receptor Modulators
Toremifene
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009