CClinicalTrials.gg
Sign In
CompletedNCT00020735Updated Dec 2, 2015

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

A Phase 2 interventional study of toremifene and conventional surgery in Prostate Cancer, sponsored by Joel Nelson, MD. Completed at 1 site in United States. Open to male participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2015-12-02.

Sponsored by Joel Nelson, MD · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 120 Years
Sex
Male
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Prostate Cancer

Browse trials for

Keywords

  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage II prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 45 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

This is the only study on the registry with Joel Nelson, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    oral toremifene

    Drug: toremifene · Procedure: neoadjuvant therapy

  • Other
    observation

    Procedure: conventional surgery

Interventions

  • Drugtoremifene
  • Procedureconventional surgery
  • Procedureneoadjuvant therapy
06

What researchers measure

Primary outcomes

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

07

Study locations

1 site
  • Hillman Cancer Center at University of Pittsburgh Cancer Institute
    Pittsburgh, Pennsylvania 15232, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00020735
Lead sponsor
Joel Nelson, MD
Collaborators
National Cancer Institute (NCI)
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) — Sponsor-investigator
First posted
Jan 27, 2003
Start date
Apr 2001
Primary completion
Jan 2005
Completion
Jun 2009
Last update
Dec 2, 2015

Study contacts

Joel B. Nelson, MD
study chair · University of Pittsburgh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Prostatic Neoplasms→

Start the discussion