Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: docetaxel; LHRH agonist; surgery
Intervention description: 75 mg/m^2 will be administered intravenously over one hour on Day 1 of each cycle, every 21 days; Given intramuscularly; Patients undergo radical prostatectomy with staging pelvic lymphadenectomy.
Intervention MeSH terms: Docetaxel; Leuprolide; Goserelin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 788.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; adenocarcinoma of the prostate

Summary:

      RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as
      goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel
      and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount
      of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and
      leuprolide or goserelin before surgery is more effective than surgery alone in treating
      patients with prostate cancer.

      PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin to
      see how well they work when given before surgery compared with surgery alone in treating
      patients with high-risk localized prostate cancer.
    

Eligibility criteria:

        1. Histologic documentation - Histologic documentation of prostatic adenocarcinoma.

             Patients with small cell, neuroendocrine, or transitional cell carcinomas are not
             eligible.

             All eligible patients must have a known Gleason sum based on biopsy or TURP at the
             time of registration.

          2. Clinically localized disease - Patients must have clinical stage T1-T3a and no
             radiographic evidence of metastatic disease as demonstrated by:

               -  EITHER CT or MRI of the abdomen and pelvis, OR endorectal MRI of the pelvis that
                  demonstrate no nodes > 1.5 cm. If one or more pelvic lymph node(s) measures > 1.5
                  cm, a negative biopsy is required. If more than one lymph node is > 1.5 cm, the
                  largest or most accessible node should be biopsied.

             AND

               -  Negative bone scan (with plain films and/or MRI and/or CT scan confirmation, if
                  necessary). Positive PET and Prostascint scans are not considered proof of
                  metastatic disease.

          3. Determination of high-risk status: Patients must have either:

               -  A Kattan nomogram predicted probability of being free from biochemical
                  progression at 5 years after surgery of < 60%.

             OR

               -  Prostate biopsy Gleason sum ≥ 8 (NOTE: The Kattan nomogram probability must be
                  calculated for all patients, including those eligible based on Gleason sum ≥ 8
                  only.)

          4. Prior treatment - No prior treatment for prostate cancer including prior surgery
             (excluding TURP), pelvic lymph node dissection, radiation therapy, or chemotherapy.

             Patients may have received up to 4 months of androgen deprivation therapy (LHRH
             agonists, antiandrogens, or both) prior to being enrolled on the study.

          5. Appropriate surgical candidates - Patients must be appropriate candidates for radical
             prostatectomy with an estimated life expectancy > 10 years as determined by a
             urologist. Evidence of underlying cardiac disease should be evaluated prior to
             enrollment to ensure that patients are not at high risk of cardiac complications.

          6. Clotting history - Patients with a history of deep venous thrombosis, pulmonary
             embolism, and/or cerebrovascular accident or currently requiring systemic
             anticoagulation are eligible provided they are determined to be candidates for radical
             prostatectomy.

          7. ECOG performance status: 0-2

          8. Age: ≥ 18 years of age

          9. Required Initial Laboratory Values:

               -  ANC ≥ 1500/μL

               -  Platelet count ≥ 150,000/μL

               -  Creatinine ≤ 2.0 mg/dL

               -  Pre-registration serum PSA level ≤ 100 ng/mL

               -  Bilirubin ≤ 1.5XULN (2.5XULN in patients with Gilbert's disease)

               -  AST/ALT ≤1.5XULN