Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Re… (NCT01487863) | Clinical Trial Compass
CompletedPhase 2
Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer
United States69 participantsStarted 2011-12
Plain-language summary
The purpose of this study was to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on the ability to manufacture sipuleucel-T (by assessing sipuleucel-T product parameters), and to assess the safety and efficacy of sipuleucel-T with concurrent or sequential administration of abiraterone acetate plus prednisone in men with metastatic castrate resistant prostate cancer.
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* histologically documented prostate cancer confirmed by a pathology report from prostate biopsy or radical prostatectomy specimen
* metastatic status as evidenced by imaging obtained \</= 56 days prior to registration demonstrating bone metastasis or lymph node metastasis
* castrate resistant prostate cancer: castrate levels of testosterone (\</= 50 ng/dL); evidence of disease progression concomitant with surgical or medical castration
* serum PSA \>/= 2.0 ng/mL
* castrate levels of testosterone (\</= 50 ng/dL) achieved via medical or surgical castration
* baseline Eastern Cooperative Oncology Group (ECOG) performance status of \</= 1
* systolic blood pressure (BP) \</= 140 mm Hg and diastolic BP \</= 90 mm Hg at screening
* adequate baseline hematologic, renal, and liver functions
* must live in a permanent residence within a comfortable driving distance (round trip within one day) of the clinical trial site
Exclusion Criteria:
* the presence of known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites
* New York Heart Association Class III or IV heart failure
* any medical condition that may be compromised by increases in blood pressure, hypokalemia, or fluid retention
* Child-Pugh Class B or C hepatic insufficiency
* spinal cord compression, imminent long bone fracture, or any other condition likely to require radiation therapy and/or steroids for pain control
* known adrenalcortical insufficiency
* any medical contra…
What they're measuring
1
Cumulative CD54 Upregulation Ratio Between the Cohorts.
Timeframe: Over the course of sipuleucel-T therapy (approximately 1 month)