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Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer Clinical research trials and Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer. Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer  Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer
Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer
For Condition: Prostate Cancer
Status: Recruiting
Sponsor(s): Pfizer ,
Synopsis: This is a multi-center, open label, randomized study. Patients will be randomized to one of the following arms with an allocation ratio of 3:1, respectively: Arm A: Investigational Drug + neoadjuvant hormone therapy (NHT) OR Arm B: neoadjuvant hormone therapy. After randomization, patients will receive study treatment for three cycles (one cycle is defined as 28 days). After completion of three cycles, patients will undergo a prostatectomy and pathology assessments will be completed at a central laboratory, the Armed Forces Institute of Pathology (AFIP) in Washington, DC. Up to 52 response evaluable patients are expected to be enrolled in this study.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry Criteria: Inclusion: - Histologically confirmed adenocarcinoma of the prostate, previously untreated - Potential candidate for radical prostatectomy on the basis of the patient’s general medical condition, performance status, and life expectancy - Potential candidate for NHT prior to prostatectomy, including high or intermediate risk of recurrence, based on an estimated risk of biochemical recurrence: High risk category: PSA >20 or Gleason score 8 or cT2c/cT3 OR Intermediate risk category: PSA >10 and d20 or Gleason score 7 or cT2b - No evidence of metastatic disease by physical examination, bone scan, and computed tomography, or MRI, of the abdomen and pelvis - Age > 18 years - ECOG performance status 0-1 - Adequate bone marrow, hepatic, and renal function determined within 2 weeks prior to starting therapy - Availability of prostatectomy specimen for histological analysis at the Armed Forces Institute of Pathology Exclusion: - Prior hormone therapy, radiation, chemotherapy, or immunologic therapy for prostate cancer - History of, or significant risk for, chronic inflammatory or autoimmune disease - Potential requirement for systemic corticosteroids before surgery based on prior history - History of autoimmune colitis or chronic GI conditions associated with diarrhea or bleeding, or current acute colitis of any origin - Any serious uncontrolled medical disorder or active infection which would impair ability to receive study treatment and subsequent prostatectomy - Coexisting malignancies except basal or squamous cell carcinoma of the skin
Total Enrollment: 52
Location and Contact Information:
Pfizer Investigational Site *Recruiting*
Lebanon, Tennessee, 37087
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Hermitage, Tennessee, 37076
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Murfreesboro, Tennessee, 37130
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Smyrna, Tennessee, 37167
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Gallatin, Tennessee, 37066
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Nashville, Tennessee, 37207
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Nashville, Tennessee, 37211
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Nashville, Tennessee, 37205
United States
Recruiting
Additional Information:
Study ID Numbers: A3671004;
Study Start Date: January 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075192
Other Prostate Cancer Studies:
1. Lycopene In Preventing of Prostate Cancer
2. Treatment With an Investigational Compound for the Prevention of Prostate Cancer
3. Identification of Genes Associated With Cancer in Patients and Siblings Who Have Cancer
4. PSA Vaccine or Nilutamide to Treat Advanced Prostate Cancer
5. Study of Prostate Cancer in Black and White U.S. Veterans
Related Studies:
Other Prostate Cancer Clinical Trials
Other Tennessee Clinical Trials
Other Nashville Clinical Trials
Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer
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