Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer Patients - PROSTY Trial
Brief 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which schedule of docetaxel and prednisone is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying two different schedules of docetaxel and prednisone to compare how well they work in treating patients with metastatic prostate cancer.


Options:
A: Inclusion Criteria:

* Newly diagnosed metastatic prostate cancer within 3 months prior to randomization with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
* Distant metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan
* At least 2 of the following high-risk prognostic factors: Gleason score of greater than or equal to (\>=8); presence of 3 or more lesions on bone scan; presence of measurable visceral (excluding lymph node disease) metastasis on CT or MRI Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 scan
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2
* Adequate hematologic, hepatic, and renal function
* Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

* Active infection or other medical condition that would make prednisone use contraindicated
* Any chronic medical condition requiring a higher systemic dose of corticosteroid than 5 mg prednisone per day
* Pathological finding consistent with small cell carcinoma of the prostate
* Known brain metastasis
* Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer (the following exception are permitted): up to 3 months of androgen deprivation therapy (ADT) with lutenizing hormone releasing hormone agonists or antagonists or orchiectomy with or without concurrent anti-androgens prior Cycle 1 Day 1; participants may have one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 28 days prior to Cycle 1 Day 1)
B: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed adenocarcinoma of the prostate

  * Metastatic disease by imaging or clinical examination
* Hormone-refractory disease, defined as prostate-specific antigen (PSA) level \> 10 µg/L AND rising between 2 sequential measurements
* Testosterone within castration levels by orchiectomy or medical castration comprising luteinizing hormone-releasing hormone (LHRH) analogues

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* WHO 0-2

Life expectancy

* Not specified

Hematopoietic

* Neutrophil count ≥ 1,500/mm\^3
* Hemoglobin ≥ 11.0 g/dL
* Platelet count ≥ 100,000/mm\^3

Hepatic

* ALT and AST ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin normal
* Alkaline phosphatase ≤ 6 times ULN (unless due to the presence of extensive bone disease)
* No serious liver disease

Renal

* Creatinine ≤ 1.5 times ULN

Cardiovascular

* No ischemic or thromboembolic cardiac disease
* No myocardial infarction within the past 12 months
* No other serious cardiac disease

Pulmonary

* No pulmonary emboli

Immunologic

* No active infection
* No autoimmune disease, including any of the following:

  * Lupus
  * Scleroderma
  * Rheumatoid polyarthritis

Other

* No active peptic ulcer
* No unstable diabetes mellitus
* No contraindication to corticosteroids
* No other malignant disease within the past 5 years except basalioma
* No functional iron deficiency (i.e., transferrin saturation \< 20%) that cannot be treated with iron supplementation
* No other serious illness or medical condition

PRIOR CONCURRENT THERAPY:

Biologic therapy

* More than 2 months since prior recombinant human epoetin alfa or any other erythropoiesis-stimulating drug

Chemotherapy

* At least 3 weeks since prior estramustine

Endocrine therapy

* See Disease Characteristics
* At least 3 weeks since prior antiandrogen treatment
* Concurrent chemical castration with LHRH allowed provided patient has begun treatment prior to study entry

  * No initiation of chemical castration therapy during study treatment

Radiotherapy

* No prior radiotherapy to \> 25% of bone marrow
* No prior radioisotope therapy
* Concurrent local palliative radiotherapy for pain allowed

Surgery

* See Disease Characteristics
* At least 4 weeks since prior surgery

Other

* No other prior cytostatic treatment
* Concurrent bisphosphonates allowed provided patient has begun treatment prior to study entry

  * No initiation of bisphosphonates during study treatment
C: DISEASE CHARACTERISTICS:

* Histologically confirmed prostate adenocarcinoma

  * Metastatic disease
* Measurable or evaluable disease
* No brain metastases

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* At least 3 months

Hematopoietic

* WBC ≥ 2,000/mm\^3
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* Bilirubin ≤ 1.5 times upper limit of normal (ULN) (2.5 times normal if hepatic metastases are present)
* AST and ALT ≤ 1.5 times ULN (2.5 times normal if hepatic metastases are present)

Renal

* Creatinine ≤ 150 μmol/L

Cardiovascular

* No symptomatic coronary disease
* No congenital cardiac insufficiency
* No New York Heart Association class III or IV cardiovascular disease
* No other severe cardiovascular disease

Other

* No severe peripheral neuropathy
* No active infection
* No other malignancy within the past 5 years except basal cell skin cancer
* No familial, social, geographical, or psychological situation that would preclude study compliance and follow-up
* No other serious disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy for metastatic prostate cancer
* Prior chemotherapy allowed provided all of the following are true:

  * Chemotherapy was completed \> 1 year ago
  * Prostate-specific antigen level has remained stable
  * No development of metastases within 1 year after completion of chemotherapy

Endocrine therapy

* Prior hormonal therapy within the past 2 months allowed for metastatic prostate cancer

Radiotherapy

* More than 4 weeks since prior radiotherapy to metastatic sites

Surgery

* No prior surgical castration

Other

* No other concurrent investigational drugs
D: 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

Answer: B