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A Phase II Randomized Controlled Clinical Trial Of The Antiestrogen GTx-006 In Subjects With Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase II Randomized Controlled Clinical Trial Of The Antiestrogen GTx-006 In Subjects With 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Joel B. Nelson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Federal Government

Study ID:

CDR0000068708

NCT ID:

NCT00020735

Start Date:

April 2001

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage II prostate cancer
  • Prostatic Neoplasms

Name

Location

Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236