Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: docetaxel; prednisone; Radical prostatectomy; Radiation therapy
Intervention description: Docetaxel 20mg/m2/week IV every week during standard of care radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.; Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.; Radical prostatectomy as part of standard care; Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
Intervention MeSH terms: Prednisone; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
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; stage IV prostate cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel may make
      tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation
      therapy and prednisone after surgery may kill any tumor cells that remain after surgery.

      PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation
      therapy and prednisone works in treating patients who have undergone surgery for prostate
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed prostate cancer

          -  Prostate-specific antigen (PSA) level > 0.2 ng/mL after radical prostatectomy
             performed ≥ 6 weeks ago

          -  No lymph node-positive prostate cancer

          -  No documented metastatic disease

               -  CT scan of the abdomen and pelvis negative (within the past 6 months)

               -  No bone pain OR negative bone scan (within the past 6 months)

          -  ECOG performance status 0-2

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 9 g/dL

          -  Bilirubin normal

          -  ALT and AST ≤ 1.5 times upper limit of normal

          -  Alkaline phosphatase normal

          -  Fertile patients must use effective contraception

          -  No peripheral neuropathy > grade 1

          -  No other malignancy within the last 5 years that could affect the diagnosis or
             assessment of prostate cancer

          -  No serious illness with a life expectancy of < 5 years

          -  No concurrent medical, psychological, or social circumstance that would preclude study
             compliance

          -  No history of severe hypersensitivity reaction to docetaxel or other drugs formulated
             with polysorbate 80

        Exclusion Criteria:

          -  No prior orchiectomy

          -  No prior chemotherapy regimen for this disease

          -  No prior pelvic radiotherapy

          -  No pre- or postoperative androgen manipulation, such as luteinizing hormone-releasing
             hormone agonists, antiandrogens (flutamide, bicalutamide, or nilutamide), or
             finasteride

               -  Preoperative androgen manipulation for a duration of ≤ 3 months allowed

          -  No prior immunotherapy

          -  No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other
             systemic radioisotopes

          -  No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

          -  No concurrent herbal or alternative regimens including, but not limited to, any of the
             following:

               -  Saw palmetto

               -  PC-SPES

               -  Shark cartilage

          -  No other concurrent investigational agents

          -  No other concurrent chemotherapy, immunotherapy, or hormonal therapy (except for
             replacement steroids)