Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer

NCT00006101 | Completed Phase 2 Results DMC

• 4 other identifiers: UCI 97-18 CDR0000068110U01CA8188601NCI-P00-0164NCI-2009-00890
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of eflornithine (DMFO) may be an effective way to prevent the development of prostate cancer. PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in preventing prostate cancer in patients who are at high risk of developing the disease.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer

Outcome Measures

Primary Outcomes (1)

• Change in Total PSA, Percent Free PSA, and Prostate Volume at 12 Months

  Difference refers to absolute difference of 12 months to baseline and % relative difference refers to the ratio of the absolute difference divided by the baseline times 100.

  Baseline and 12 months

Study Arms (2)

eflornithine

EXPERIMENTAL

500mg/d for 12 months

Drug: eflornithine

Placebo

PLACEBO COMPARATOR

placebo for 12 months

Drug: Placebo

Interventions

eflornithine DRUG

Take 500mg of DFMO per day for 12 months

Also known as: Difluoromethylornithine (DFMO)

eflornithine

Placebo DRUG

Take placebo per day for 12 months

Placebo

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Criteria for Eligibility 1. Men between the ages of 35 and 70 with family history of prostate cancer, i.e., prostate cancer diagnosed in two first degree relatives before the age of 70 years. (First degree relatives include a brother, father, and son.) There will be occasions in which a second or even third degree relative will be eligible. Additional information regarding these criteria is provided below and in Attachment 1.) * Two or more affected relatives of which at least 1 is a first degree relative or * At least two affected relatives, both of which are at least a second degree relative or * One first degree relative diagnosed with prostate cancer at age 55 or less. 2. No history of invasive cancer within 5 years (though non-melanoma skin or papillary bladder cancer will not be reason to exclude a patient); no prior history of prostate cancer, no severe metabolic disorders or other life-threatening acute or chronic disease; no additional x-ray or chemotherapy anticipated. * Men found to have localized prostate cancer (Gleason score ≤7) as part of the screening for the current trial, and opt for watchful waiting as their standard of care treatment for their condition, will be eligible to sign an additional consent form to continue with the randomization and on-study activities of this trial. On-study activities for these individuals will not differ from the on-study activities for the other men enrolled in this trial. 3. Must not require a medically mandated special diet which precludes compliance with study requirements 4. Not requiring regular use of anticoagulants on a regular basis. Prior use of chemoprevention agent(s) (such as Proscar) is allowed as long as the subject has been off the agent(s) for at least 3 months. Not currently participating in another prostate prevention trial. 5. Absence of history of current documented or symptomatic gastric or duodenal ulcer within 12 months prior to study entry, or of significant kidney or liver disease. No chronic anemia (hematocrit \< 35 volume %), leukopenia (WEB \<4,000) with normal differential, or thrombocytopenia (platelets \<100,000) and with serum creatinine \<1.5 mg/dl, serum bilirubin \<2.0 mg/dl, and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) \<2× normal. Urinalysis should have \<1+ protein, 0-3 casts, 0-5 white blood cell count (WBC) and red blood cell count (RBC). 6. Absence of any condition that predisposes to difficulties with hearing, wound healing or repair. 7. Must meet Southwest Oncology Group performance status criteria of 0-1 (0 = fully active, able to carry on all predisease activities without restriction \[Karnofsky scale 90-100\]; 1 = restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, i.e., light housework or office work \[Karnofsky scale 70-80\]. 8. Subjects must be willing and able to keep required visits for study procedures and to complete study questionnaires. 9. Patient must not have had radiation therapy in the pelvic area.

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

Sponsors & Collaborators

• Thomas E. Ahlering: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

Orange, California, 92868, United States

Location

Related Publications (1)

• Simoneau AR, Gerner EW, Nagle R, Ziogas A, Fujikawa-Brooks S, Yerushalmi H, Ahlering TE, Lieberman R, McLaren CE, Anton-Culver H, Meyskens FL Jr. The effect of difluoromethylornithine on decreasing prostate size and polyamines in men: results of a year-long phase IIb randomized placebo-controlled chemoprevention trial. Cancer Epidemiol Biomarkers Prev. 2008 Feb;17(2):292-9. doi: 10.1158/1055-9965.EPI-07-0658.

  PMID: 18268112 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Eflornithine

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)

Ornithine; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino

Results Point of Contact

• Title: Dr. Thomas Ahlering
• Organization: University of California, Irvine

tahlerin@uci.edu

(714) 456-6068

Study Officials

• Thomas Ahlering, MD

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2000
• First Posted: January 27, 2003
• Study Start: October 1, 1998
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 14, 2018
• Results First Posted: April 12, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)