Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GTx
ClinicalTrials.gov Identifier:
NCT00106691
First received: March 29, 2005
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia (PIN).


Condition Intervention Phase
Preneoplastic Conditions
Prostatic Intraepithelial Neoplasia
Drug: Toremifene 20 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN)

Resource links provided by NLM:


Further study details as provided by GTx:

Primary Outcome Measures:
  • To assess the efficacy of toremifene in the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN) [ Time Frame: the primary outcomes measure was taken at 12, 24 and 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety of toremifene in men with high grade PIN [ Time Frame: at each visit of the study ] [ Designated as safety issue: No ]
  • To assess the effect of toremifene on lipid levels [ Time Frame: baseline and month 36 ] [ Designated as safety issue: No ]
  • To assess the effect of toremifene on hormone levels [ Time Frame: baseline and month 36 ] [ Designated as safety issue: No ]
  • To assess the effect of toremifene on total and % free serum PSA (prostate specific antigen) levels [ Time Frame: baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months ] [ Designated as safety issue: No ]
  • To assess the effect of toremifene on the AUA (American Urological Association) symptom score [ Time Frame: baseline and 36 months ] [ Designated as safety issue: No ]
  • To assess the population pharmacokinetics of 20 mg toremifene in men [ Time Frame: baseline, 3 months, 6 months, 12 months, 18 months, 24 months, and 30 months ] [ Designated as safety issue: No ]

Enrollment: 1590
Study Start Date: January 2005
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: toremifene 20mg Drug: Toremifene 20 mg
20 mg once a day
Placebo Comparator: Placebo Drug: Placebo
placebo tablet identically appearing to the toremifene 20 mg tablet, administered daily for 360 days.

Detailed Description:

The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia. Men who have ever been diagnosed with high grade PIN will be enrolled into an 36 month trial and will be assigned to either 20 mg of study drug or placebo per day. Subjects will undergo safety evaluations at Month 3, Month 6, Month 12, Month 18, Month 24, Month 30 and Month 36 along with prostate biopsies at Month 12 and Month 24 and Month 36 to determine efficacy.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Give voluntary signed informed consent in accordance with institutional policies
  • Be male, aged ≥ 30 years
  • Have a diagnosis of high grade PIN from any previous prostate biopsy. The diagnosis of high grade PIN must be confirmed by the central pathologist
  • Have had a prostate biopsy in the last 6 months with a minimum of 10 cores that shows no evidence of cancer as confirmed by the central pathologist; OR, have had 2 prostate biopsies (each with a minimum of 6 cores) in the 12 months prior to screening with at least one of the biopsies occurring within 6 months prior to the screening visit. Both biopsies should have no evidence of cancer as confirmed by the central pathologist
  • Have a serum PSA of ≤ 10 ng/mL
  • Agree to provide tablet containers for tablet counts
  • Agree to use an effective method of contraception, if the partner is of child-bearing age, while on study
  • Have adequate bone marrow, liver and renal function:

    • White Blood Cell (WBC) Count ≥ 3,000/mm3;
    • Platelet Count ≥ 100,000/mm3;
    • Bilirubin ≤ 1.5 mg/dL;
    • AST and ALT < 2x upper limit of normal;
    • Serum Creatinine ≤ 2.0 mg%

Exclusion Criteria:

  • Previous exposure to toremifene citrate
  • Have evidence of prostate cancer (local, regional and/or distal metastasis)
  • Have any history of other malignancies (exceptions include non-melanoma skin cancer or other cancer that has no evidence of tumor reoccurrence, 5 years after definitive treatment). Superficial bladder cancer is acceptable as long as it has been greater than 1 year since any treatment with no evidence of recurrence.
  • Have active systemic viral, bacterial, or fungal infections requiring treatment
  • Have, in the judgment of the investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol
  • Concurrently being treated with other investigational agents or have participated in an investigational study within 30 days prior to screening
  • Currently taking dutasteride. Subject is eligible if he stops dutasteride for a total washout of 90 days prior to the Screening Visit and agrees not to use dutasteride for the duration of the study.
  • Have previously taken finasteride for greater than two years
  • Currently taking finasteride. Subject is eligible if he stops finasteride for a total washout of 30 days prior to the Screening Visit and agrees not to use finasteride for the duration of the study.
  • Currently taking testosterone or testosterone-like supplements, such as dehydroepiandrosterone (DHEA). Subject is eligible if he stops these agents for a total washout of 30 days prior to the Screening Visit and agrees not to use these agents for the duration of the study.
  • Have a history of taking PC-SPES within the past two years.
  • Currently taking herbal medicine or dietary supplements for prostate health, such as Saw Palmetto (also known as Serenoa repens).

Subject is eligible if he stops these agents for a total washout of 30 days prior to taking the first dose of study drug and agrees not to use these agents for the duration of the study.

Lycopene, vitamin E and selenium are not prohibited and no washout is required. However, vitamin E intake should be limited to less than 400 i.u. per day.

  • Have a history of thromboembolic event or disease including deep vein thrombosis, pulmonary embolus, or thrombotic stroke
  • History of chronic hepatitis or cirrhosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106691

  Show 39 Study Locations
Sponsors and Collaborators
GTx
  More Information

No publications provided by GTx

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GTx
ClinicalTrials.gov Identifier: NCT00106691     History of Changes
Other Study ID Numbers: G300104
Study First Received: March 29, 2005
Last Updated: January 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GTx:
neoplasia
chemoprevention
cancer
premalignant
precancerous
Chemoprophylaxis
Intraepithelial Prostatic Neoplasia
Neoplasia, Prostatic Intraepithelial

Additional relevant MeSH terms:
Carcinoma in Situ
Neoplasms
Precancerous Conditions
Prostatic Intraepithelial Neoplasia
Prostatic Neoplasms
Carcinoma
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms
Toremifene
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Bone Density Conservation Agents
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014