Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer
Condition: Metastatic Hormone-sensitive Prostate Cancer
MeSH terms: Prostatic Neoplasms; Hypersensitivity
Intervention: androgen-deprivation therapy; docetaxel
Intervention description: LHRH analogs are administered with a variety of techniques such as subcutaneously, intramuscularly, or insertion, while antiandrogens (flutamide and bicalutamide) were given orally.; Given IV
Intervention MeSH terms: Docetaxel; Androgens
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 790.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic hormone-sensitive prostate cancer; docetaxel

Summary:

      RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy
      may stop the adrenal glands from making androgens. 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. It is not yet known whether androgen-ablation
      therapy is more effective with or without docetaxel in treating metastatic prostate cancer.

      PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and
      chemotherapy to see how well they work compared to androgen-ablation therapy alone in
      treating patients with metastatic prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed prostate cancer

          -  Metastatic disease

          -  On androgen-deprivation therapy for < 120 days

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

               -  PS 2 eligible only if decline in PS is due to metastatic prostate cancer

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Bilirubin ≤ upper limit of normal (ULN)

          -  Alanine aminotransferase (ALT) ≤ 2.5 times ULN

          -  Creatinine clearance ≥ 30 mL/min

          -  Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 times ULN (unless
             on therapeutic anticoagulation)

          -  Partial thromboplastin time (PTT) ≤ 1.5 times ULN (unless on therapeutic
             anticoagulation)

          -  Fertile patients must use effective contraception

          -  At least 4 weeks since prior major surgery and recovered from all toxicity prior to
             randomization

          -  Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following are
             true:

               -  Therapy was discontinued ≥ 12 months ago AND there is no evidence of disease, as
                  defined by 1 of the following:

                    -  PSA < 0.1 ng/dL after prostatectomy plus hormonal therapy

                    -  PSA < 0.5 ng/dL and has not doubled above nadir after radiotherapy plus
                       hormonal therapy

               -  Therapy lasted no more than 24 months

                    -  Last depot injection must have expired by the 24-month mark

          -  Prior palliative radiotherapy allowed if commenced within 30 days before starting
             androgen deprivation

          -  Anti-androgen therapy allowed as single-agent therapy ≤ 7 days before medial
             castration to prevent flare

          -  More than 30 days (or 6 half-lives) (whichever is longer) since prior participation in
             another clinical trial

          -  Concurrent participation in nontherapeutic trials allowed

          -  Concurrent antiandrogen therapy (e.g., bicalutamide or flutamide) allowed, but not as
             sole hormonal therapy

        Exclusion Criteria:

          -  Prostate-specific antigen (PSA) level has risen and met criteria for progression from
             its lowest point between the start of androgen-deprivation therapy and randomization

          -  Prior malignancy in the past 5 years except for basal cell or squamous cell carcinoma
             of the skin

               -  Other malignancies that are considered to have low potential to progress (e.g.,
                  grade 2, T1a transitional cell carcinoma) may be allowed if approved by study
                  chair

          -  Peripheral neuropathy > grade 1

          -  History of severe hypersensitivity reaction to docetaxel or other drugs formulated
             with polysorbate 80

          -  Active cardiac disease, including the following:

               -  Active angina

               -  Symptomatic congestive heart failure

               -  Myocardial infarction within the past 6 months

          -  Prior chemotherapy in adjuvant or neoadjuvant setting

          -  Prior hormone therapy in the metastatic setting

          -  Concurrent 5-alpha reductase inhibitors

          -  Simultaneous enrollment on Cancer and Leukemia Group B (CALGB) 90202