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

NCT00020735 | Completed Phase 2 DMC

• 4 other identifiers: PCI-00-105CDR0000068708PCI-N01-CN-75018NCI-P01-0181
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

oral toremifene

EXPERIMENTAL

Drug: toremifene; Procedure: neoadjuvant therapy

observation

OTHER

Procedure: conventional surgery

Interventions

toremifene DRUG

oral toremifene

conventional surgery PROCEDURE

observation

neoadjuvant therapy PROCEDURE

oral toremifene

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Joel Nelson, MD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Toremifene; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Combined Modality Therapy; Therapeutics

Study Officials

• Joel B. Nelson, MD

  University of Pittsburgh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chairman, Department of Urology, University of Pittsburgh School of Medicine; Chief, Division of Surgery, UPMC Shadyside Hospital

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: April 1, 2001
• Primary Completion: January 1, 2005
• Study Completion: June 1, 2009
• Last Updated: December 2, 2015

Record last verified: 2015-12

Locations

US (1)