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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)


Phase 3
30 Years
N/A
Not Enrolling
Male
Preneoplastic Conditions, Prostatic Intraepithelial Neoplasia

Thank you

Trial Information

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)


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

To assess the efficacy of toremifene in the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN)

Outcome Time Frame:

the primary outcomes measure was taken at 12, 24 and 36 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

G300104

NCT ID:

NCT00106691

Start Date:

January 2005

Completion Date:

February 2010

Related Keywords:

  • Preneoplastic Conditions
  • Prostatic Intraepithelial Neoplasia
  • neoplasia
  • chemoprevention
  • cancer
  • premalignant
  • precancerous
  • Chemoprophylaxis
  • Intraepithelial Prostatic Neoplasia
  • Neoplasia, Prostatic Intraepithelial
  • Neoplasms
  • Prostatic Neoplasms
  • Precancerous Conditions
  • Prostatic Intraepithelial Neoplasia
  • Carcinoma in Situ

Name

Location

Atlantic Urological AssociatesDaytona Beach, Florida  32114
Michigan Institute of UrologyDetroit, Michigan  48236
South Florida Medical ResearchAventura, Florida  33180
Urology Research OptionsAurora, Colorado  80012
Advanced Research InstituteNew Port Richey, Florida  34652
Urology of Indiana, LLCIndianapolis, Indiana  46202
Urology Associates, P.C.Denver, Colorado  80210
Florida Foundation for Healthcare ResearchOcala, Florida  34474
Winter Park Urology AssociatesOrlando, Florida  32803
Oregon Urology SpecialistsEugene, Oregon  97401
Urologic Associates of AllentownAllentown, Pennsylvania  18103
Mckay UrologyCharlotte,, North Carolina  28204
Urological Associates of Lancaster, Ltd.Lancaster, Pennsylvania  17604
Specialty Care ResearchPeoria, Illinois  61614
Regional Urology, LLCShreveport, Louisiana  71106
HOPE Research Institute, LLCPhoenix, Arizona  85032
San Bernardino Urological Associates Medical GroupSan Bernardino, California  92404
Metropolitan Urology, PSCJeffersonville, Indiana  47130
Anne Arundel UrologyAnnapolis, Maryland  21401
Drs. Werner, Murdock, & Francis PA, Urology AssociatesGreenbelt, Maryland  20770
Brigham & Women's Hospital, Division of Urological SurgeryBoston, Massachusetts  02115
Michigan Medical, PC UrologyGrand Rapids, Michigan  49546
Midwest Urology CenterIndependence, Missouri  64055
Kansas City Urology Care, P.C.Kansas City, Missouri  64131
Urology Healthcare AssociatesWestampton, New Jersey  08060
The Urological Institute of Northeastern Research DepartmentAlbany, New York  12208
Metropolitan Urologic Services, P.C.Elmont, New York  11003
Tri-State Urologic Services/PSC, Inc. d/b/a The Urology GroupCincinnati, Ohio  45212
Columbus Urology, Inc.Columbus, Ohio  43214
Urologic Specialists of Oklahoma Research DepartmentTulsa, Oklahoma  74104
Urologic Surgery, P.C.Bala Cynwyd, Pennsylvania  19004
University of Pittsburgh, Department of UrologyPittsburgh, Pennsylvania  15232
State College Urologic Associates, Inc.State College, Pennsylvania  16801
Urology Center of the SouthGermantown, Tennessee  38138
Southeast Urology NetworkMemphis, Tennessee  38119
Urology San Antonio Research, PASan Antonio, Texas  78229