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Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer conditions. Clinical Trials Search.org is a website devoted 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 medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as 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 permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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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. Gene-Environment Interaction in Prostate Cancer
2. Calcifidol Therapy in Men with Cancer
3. PSA Vaccine or Nilutamide to Treat Advanced Prostate Cancer
4. Lycopene In Preventing of Prostate Cancer
5. Evaluate risk factors which predict the transformation of early stage to clinically aggressive prostate cancer.
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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