Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: bicalutamide; docetaxel; flutamide; LHRH agonist; 3-dimensional conformal radiation therapy; radiation therapy
Intervention description: 50 mg (one tablet) daily orally for 6 months, starting within 6 months after registration; 75 mg/m2 IV over 1 hour on day 1 of each cycle q21 days for 6 cycles, starting 3-6 weeks after completion of radiation therapy; 250 mg (two 125-mg capsules) three times daily (total 750 mg) orally for 6 months, starting within 6 months after registration; LHRH agonist (such as leuprolide, goserelin, buserelin, or triptorelin) for 6 months, starting within 6 weeks after registration; 66.6 Gy (1.8 Gy per fraction, 5 days per week) to the prostate bed (IMRT or 3DCRT), starting 8 weeks after start of hormones
Intervention MeSH terms: Docetaxel; Bicalutamide; Flutamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer

Summary:

      RATIONALE: Specialized radiation therapy that delivers a high-dose of radiation directly to
      the tumor may kill more tumor cells and cause less damage to normal tissue. Androgens can
      cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide,
      goserelin, flutamide, or bicalutamide, may lessen the amount of androgens made by the body.
      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. Giving radiation
      therapy together with androgen suppression and docetaxel after surgery may kill any tumor
      cells that remain after surgery.

      PURPOSE: This phase II trial is studying how well giving radiation therapy together with
      androgen suppression and docetaxel works in treating patients with high risk prostate cancer
      who have undergone radical prostatectomy.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Pathologically proven adenocarcinoma of the prostate gland meeting one of the
             following criteria:

               -  Gleason ≥ 7and post-operative PSA nadir > 0.2 ng/ml with any pathologic tumor
                  (pT) classification

               -  Gleason ≥ 8, post-operative PSA nadir ≤ 0.2 ng/ml and ≥ pT3a classification

          -  Must have undergone radical prostatectomy within the past year

          -  PSA must be obtained within 6 weeks (42 days) prior to study registration

          -  No lymph node or distant metastases (N0, M0), based upon the following minimum
             diagnostic workup:

               -  History and physical examination within 8 weeks prior to study registration

               -  Bone scan and CT or MRI of the pelvis and no evidence of osseous metastases on
                  bone scan within 16 weeks prior to study registration

          -  No pelvic lymph nodes > 1.5 cm in greatest dimension on CT scan or MRI of the pelvis
             within 16 weeks prior to study registration, unless the enlarged lymph node is
             biopsied and negative

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-1

          -  Absolute neutrophil count (ANC) ≥ 2,000/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0
             g/dL is acceptable)

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times upper
             limit of normal (ULN)

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Total bilirubin ≤ 1.2 times ULN

          -  No other invasive malignancy within the past 3 years except non-melanomatous skin
             cancer

          -  No active, severe co-morbidity, including any of the following:

               -  Unstable angina and/or congestive heart failure requiring hospitalization within
                  the past 6 months

               -  Transmural myocardial infarction within the past 6 months

               -  Acute bacterial or fungal infection requiring intravenous antibiotics

               -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness
                  requiring hospitalization or precluding study therapy

               -  AIDS

                    -  HIV testing is not required for study entry

          -  No prior allergic reaction to the study drug(s)

        PRIOR CONCURRENT THERAPY:

          -  No prior systemic chemotherapy for prostate cancer

          -  More than 3 years since prior chemotherapy for a different cancer

          -  No prior androgen deprivation for treatment of prostate cancer

               -  Prior use of hormonal agents, such as finasteride or dutasteride, for treatment
                  of benign prostatic hypertrophy is allowed

          -  No prior radiotherapy to the region of the prostate that would result in overlap of
             radiotherapy fields