Salvage Radiation Therapy and Taxotere for PSA Failure After Radical Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Docetaxel (Taxotere)
Intervention description: Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
Intervention MeSH terms: Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate; Radiation

Summary:

      The main purpose of this study is to try to find out whether adding chemotherapy to the
      standard treatment for your stage of prostate cancer is more effective than the standard
      treatment by itself. The kind of treatment that most physicians would consider standard for
      this stage of prostate cancer is radiation therapy alone, possibly in combination with
      hormonal therapy. In this study, all patients will receive chemotherapy and radiation
      therapy. It is hoped that chemotherapy will be found to provide additional benefit, but
      chemotherapy has significant side effects. The use of chemotherapy is experimental in
      prostate cancer; it needs to be tested to determine if it is beneficial and to find out more
      about the side effects of the two different treatments. This study is to determine the
      effects, good and/or bad, of adding chemotherapy to radiation therapy as "salvage" treatment
      for recurrent prostate cancer after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18

          -  Performance Status: Karnofsky performance status ≥ 80% (Performance status is an
             attempt to quantify cancer patients' general well-being and activities of daily life.
             The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death.)

          -  Has undergone prostatectomy for histologically confirmed adenocarcinoma of the
             prostate at least 6 weeks prior to registration. (If prostatectomy was completed at an
             outside facility, a University of Michigan pathology review must take place to confirm
             adenocarcinoma.)

          -  Has biochemical evidence of failure as determined by at least two PSA measurements
             after prostatectomy. This must be demonstrated by an increase of at least 0.1 ng/mL
             between two consecutive measurements, both obtained after prostatectomy. The most
             recent measurement (within 28 days of registration) must be 0.3 ng/mL or greater.

          -  Has undergone pelvic CT (Computerized Tomography) scan and radionuclide bone scan
             within 90 days prior to registration that showed no evidence of regional or distant
             nodal or bone metastasis.

          -  Patients with pelvic or abdominal lymph nodes equivocal or questionable by imaging are
             eligible if the nodes are < 1.5 cm in long axis.

          -  Equivocal bone scan findings are allowed if plain films show no conclusive evidence of
             metastasis.

          -  Hematologic Criteria: CBC (Complete Blood Count)/differential obtained within 28 days
             prior to registration on study, with adequate bone marrow function defined as follows:

               -  Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3

               -  Platelets ≥ 100,000 cells/mm3

               -  Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to
                  achieve Hgb = 8.0 g/dl is acceptable).

          -  Hepatic Criteria within 28 days prior to registration:

               -  Total bilirubin < 1 x institutional upper limit of normal (ULN)

               -  ALT (Alanine Transaminase), AST (Aspartate Aminotransferase), and alkaline
                  phosphatase must be within the eligible ranges stipulated in protocol table

               -  Serum creatinine < 2 x ULN

          -  Both radiation oncology and medical oncology consultation prior to registration.

          -  Pharmacologic androgen ablation for prostate cancer will be allowed only if given
             prior to prostatectomy.

          -  Patient must sign study specific informed consent prior to study entry.

          -  Peripheral neuropathy: must be ≤ grade 1

          -  Patients must be willing to consent to using effective contraception while on
             treatment and for at least 3 months thereafter.

        Exclusion Criteria:

          -  Patients with a history of severe hypersensitivity reaction to docetaxel or other
             drugs formulated with polysorbate 80.

          -  Evidence of M1 metastatic disease

          -  Pathologically positive lymph nodes or nodes > 1.5 cm on imaging

          -  Prior pelvic radiotherapy that would result in overlap of radiation therapy fields or
             systemic cytotoxic chemotherapy.

          -  Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
             for a minimum of 5 years (for example,carcinoma in situ of the oral cavity or bladder
             are permissible)

          -  Severe, active co-morbidity, defined as follows, active co-morbidity, defined as
             follows:

               -  Unstable angina and/or congestive heart failure requiring hospitalization within
                  the 6 months prior to registration.

               -  Transmural myocardial infarction within the 6 months prior to registration

               -  Acute bacterial or fungal infection requiring intravenous antibiotics at the time
                  of registration

               -  Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition;
                  note, however, that HIV testing is not required for entry into this protocol. The
                  need to exclude patients with AIDS from this protocol is necessary because the
                  treatments involved in this protocol may be significantly immunosuppressive.