| Inclusion Criteria: | 1) All patients must have a histologic diagnosis of adenocarcinoma of the prostate which is measurable or non-measurable, Stage any T, any N, M1b and have evidence of bone metastases on bone scan. In a case, where a bone scan result is considered equivocal, then magnetic resonance imaging should be used to discriminate between malignant and other causes of bone scan abnormality. However, MRI will not be routinely incorporated into progression/response assessment. All disease must be assessed and documented on the Baseline Tumor Assessment Form
2) Patients must have metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy by one or more of the following (despite androgen deprivation and antiandrogen withdrawal when applicable) : a) Progression of measurable disease assessed within 28 days prior to registration; b) Progression of non-measurable disease (i.e., bone scan) assessed within 28 days prior to registration;
3) (# 2 Cont'd) c) Rising PSA - Rising PSA is defined as at least two consecutive rises in PSA to be documented over a reference value (measure 1). The first rising PSA (measure 2) must be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater than the second measure, and it must be obtained at least 7 days after the 2nd measure. If this is not the case, a fourth PSA is required to be taken and be greater than the second measure.
4) (# 2c cont'd) The patient must have a PSA >/= 5 ng/ml in addition to increasing PSA to be eligible by rising PSA criteria alone. However, no minimum PSA is required for patients whose progression is based on measurable or non-measurable disease.
5) All patients must have a prestudy PSA obtained within 28 days prior to registration.
6) All patients must have had a CT scan or MRI of the abdomen and pelvis within 28 days prior to registration. Patients must also have had a bone scan within 28 days prior to registration.
7) Patients must be offered the opportunity to participate in specimen banking for future use (to include the serum and tissue correlative studies, and CTC measures).
8) Patients must have been surgically or medically castrated. If method of castration is luteinizing hormone-releasing hormone (LHRH) agonists (leuprolide or goserelin) or LHRH antagonists, then the patient should be willing to continue the use of LHRH agonists. Castration using LHRH agonist should not be interrupted and patients who have stopped treatment should be willing to restart.
9) If the patient has been treated with non-steroidal antiandrogens (flutamide, bicalutamide, nilutamide or ketoconazole), effective 3/15/08 they must have been stopped at least 14 days prior to registration for ketoconazole and at least 28 days prior to registration for flutamide, bicalutamide or nilutamide and the patients must have demonstrated progression
10) Prior radiation therapy (to less than 30% of the bone marrow only) is allowed. This includes prior use of samarium, but patients can not have received prior strontium. At least 21 days must have elapsed since the completion of radiation therapy and the patient must have recovered from side effects. Soft tissue disease which has been radiated in the prior 2 months is not assessable as measurable disease.
11) Patients may have received prior surgery. However, at least 21 days must have elapsed since completion of surgery and patient must have recovered from all side effects.
12) One prior systemic therapy (vaccine or biologic therapy) is allowed and at least 28 days must have elapsed since completion of therapy and patient must have recovered from all side effects. Prior therapy must not have included cytotoxic chemotherapy for metastatic prostate cancer. Prior adjuvant therapy with a single non-taxane containing cytotoxic regimen is permitted provided more than 2 years has elapsed since its completion.
13) Patients are permitted to take bisphosphonates provided they began bisphosphonate therapy before registration to S0421, they fulfill criteria for disease progression, and that they continue them as per the manufacturer's guidelines and/or as per institutional practice. Patients not taking ongoing bisphosphonate therapy will not be permitted to start such therapy until they have completed 12 weeks of study treatment.
14) Patients must be able to take oral medication without crushing, dissolving or chewing tablets.
15) Patients must discontinue herbal medications and food supplements (e.g., PC-Spes, Saw Palmetto, St. John's Wort, etc.) before registration. Patients may continue on daily vitamins and calcium supplements.
16) Patients must have hemoglobin and alkaline phosphatase obtained within 28 days prior to registration.
17) Serum testosterone must be obtained within 28 days prior to registration.
18) Patients must not have </= Grade 2 Symptomatic Neuropathy Sensory (NCI-Common Terminology Criteria for Adverse Events).
19) Patients must not have a history of hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
20) Patients must have a Zubrod performance status of 0 - 3. For those patients with PS of 3, the cause must be due to pain secondary to bone metastases in order to be eligible.
21) No other chemotherapeutic, biological response modifiers, radiation therapy, corticosteroid or hormonal concomitant therapy (other than continuing LHRH treatment and/or bisphosphonate therapy) may be planned to be given during protocol treatment. Prior or concomitant use of megestrol acetate for the treatment of hot flashes is allowed.
22) Patients receiving finasteride, dutasteride, or other 5 alpha reductase inhibitors for the treatment of benign prostatic hypertrophy (BPH) are eligible provided treatment is clearly documented for BPH. Patients on finasteride, dutasteride or other 5 alpha reductase inhibitors for indications apart from BPH must discontinue them prior to registration.
23) Patients must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have significant active concurrent other medical illness precluding protocol treatment or survival.
24) All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. |