A Phase IIA Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide with or without Deforolimus in Men with Asymptomatic, Metastatic Castrate-Resistant Prostate Cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 156

Inclusion Criteria

1. Patient has histologically confirmed adenocarcinomas of the prostate.
2. Archival pathological material is available for submission to central laboratory.
3. Patient has evidence of metastatic disease at protocol entry or at the time of prior hormonal manipulation, determined radiographically by the presence of at least 2 bone scan lesions consistent with metastases or abdominal/pelvic lymph nodes > 2 cm on longest axial measurement. Solitary or ambiguous bone lesions should be confirmed with plain radiographs or magnetic resonance imaging (MRI).
4. Patient has evidence of disease progression despite castrate levels of testosterone (< 50 ng/dl) following orchiectomy or during therapy with a luteinizing hormone releasing hormone (LHRH) agonist or antagonist (with or without an anti-androgen). Evidence of disease progression must include one of the following:
a) Levels of PSA are defined as increasing when at least three consecutive measurements, obtained at least one week apart, show increases. (The minimum starting PSA level for trial entry is 10 ng/mL.)
b) Progressive lymph node disease is defined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The longest diameter of any node must measure at least 2 cm on spiral computed tomography (CT) to qualify as a target lesion.
c) Worsening bone scan is defined as an increase of 2 or more lesions from a previous bone scan. Solitary or ambiguous bone lesions should be confirmed with plain radiographs or MRI.
5. Patient has a PSA > 10 ng/ml.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient has received bicalutamide, flutamide, or nilutamide within the past 12 months.
2. Patient has received prior chemotherapy for metastatic prostate cancer.
3. Patient has previously received rapamycin or rapamycin analogs, including deforolimus, temsirolimus, or everolimus.
4. Patient is receiving corticosteroids administered at doses greater than those used for normal replacement therapy. .
5. Patient is receiving an opioid or narcotic analgesic prescribed for pain due to prostate cancer.
6. In the opinion of the investigator, the patient has pain related to metastatic prostate cancer that warrants the initiation of chemotherapy.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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