Molecular Features and Pathways in Predicting Drug Resistance in Patients With Metastatic Castrat… (NCT02228265) | Clinical Trial Compass
CompletedNot Applicable
Molecular Features and Pathways in Predicting Drug Resistance in Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Enzalutamide
United States41 participantsStarted 2013-03-12
Plain-language summary
This research trial studies molecular features and pathways in predicting drug resistance in patients with castration-resistant prostate cancer that has spread to other parts of the body and who are receiving enzalutamide. Studying samples of blood and tissue in the laboratory from patients receiving enzalutamide may help doctors learn more about molecular features and pathways that may cause prostate cancer to be resistant to the drug.
Who can participate
SexMALE
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Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
* Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration); for patients who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the trial
* Radiographic evidence of regional or distant metastases with suspected tumor in an area that is safe to biopsy
* Willingness to undergo a tumor biopsy at baseline and at disease progression
* Serum testosterone level \< 50 ng/dL at screening
* Progressive disease by PSA or imaging in the setting of medical or surgical castration; disease progression for study entry is defined as one or more of the following three criteria:
* PSA progression defined by a minimum of three rising PSA levels with an interval of \>= 1 week between each determination; the PSA value at screening should be \>= 2 ug/L (2 ng/ml)
* Soft tissue disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
* Bone disease progression defined by two or more new lesions on bone scan
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Clinically able, in the opinion of the investigator, to receive MDV3100 (enzalutamide)
* Willing and able to give informed consent
* A minimum of 4 weeks elapsed off of anti-androgen t…
What they're measuring
1
PSA response, a binary variable indicating whether the PSA level has declined >= 50% within 12 weeks of beginning enzalutamide treatment