Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Neoadjuvant Hormonal Therapy; Docetaxel
Intervention description: Monthly or quarterly LHRH Agonist Depot injection (leuprolide or goserelin acetate) for one year.; 35 mg/m2 by vein (IV) on Day 1, 8, 15 and 22 every 6 weeks.
Intervention MeSH terms: Docetaxel; Leuprolide; Goserelin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Male
Healthy volunteers: No
Keywords: Neoadjuvant Hormonal Therapy; Docetaxel; Taxotere; Chemotherapy; Radical Prostatectomy; Node-positive Prostate Cancer; Androgen-dependent prostate cancer; Lymph node metastases

Summary:

      The goal of this clinical research study is to find out if a therapy using docetaxel
      chemotherapy with hormonal therapy taken before your scheduled surgery is beneficial to
      treatment of prostate cancer. The safety of this combination will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with adenocarcinoma of the prostate that in the opinion of the surgeon could
             be resectable after response to systemic therapy. Ductal carcinoma variant is
             included.

          2. All patients must be regarded as acceptable anesthetic risk for radical prostatectomy
             and confirm their intention to undergo radical prostatectomy at the end of the
             neoadjuvant therapy.

          3. Zubrod performance status 2 or better.

          4. All patients must have thorough tumor staging and meet one of the following criteria:
             a) Either lymph node biopsy or lymph node dissection demonstrating presence of lymph
             node metastasis. b) Pelvic or retroperitoneal lymphadenopathy >/= 2.0 cm visualized on
             CT scan (biopsy is not required if >/= 2.0 cm and in typical distribution) c) Primary
             tumor Gleason score >/= 8 and serum PSA concentration >/= 25 ng/ml, indicating high
             risk of occult lymph node metastases.

          5. (# 4 cont'd) d) Primary tumor stage T3 and Gleason score >/= 7, indicating high risk
             of occult lymph node metastases. e) Primary tumor stage T4 indicating high risk of
             occult lymph node metastases.

          6. Prior hormonal therapy up to 6 months is permitted. No concurrent ketoconazole is
             permitted.

          7. Patients must have adequate bone marrow function defined as an absolute peripheral
             granulocyte count of > 1,500/mm^3 and platelet count of > 100,000/mm^3; adequate
             hepatic function defined with a total bilirubin of < 1.5 mg/dl and AST/ALT < 2X the
             upper limits of normal; adequate renal function defined as serum creatinine clearance
             > 40 cc/min (measured or calculated).

          8. Patients must sign an informed consent indicating that they are aware of the
             investigational nature of this study, in keeping with the policies of the institution.

          9. All patients must be evaluated in the Department of Urology and Department of
             Genitourinary Medical Oncology prior to signing informed consent.

        Exclusion Criteria:

          1. Patients with small cell or sarcomatoid histology.

          2. Patients with clinical or radiological evidence of bone or other extranodal metastasis
             (M1b or M1c).

          3. Prior chemotherapy.

          4. Patients with severe or uncontrolled intercurrent infection.

          5. Patients with New York Heart Association (NYHA) Class III/IV congestive heart failure,
             unstable angina or history of myocardial infarction within the last 6 months.

          6. Contraindications to corticosteroids.

          7. Uncontrolled severe hypertension, persistently uncontrolled diabetes mellitus,
             oxygen-dependent lung disease, chronic liver disease or HIV infection.

          8. Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3
             years.

          9. Overt psychosis, mental disability or otherwise incompetent to give informed consent.