Status:
COMPLETED
Molecular Features and Pathways in Predicting Drug Resistance in Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Enzalutamide
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
United States Department of Defense
Oregon Health and Science University
Conditions:
Castration Levels of Testosterone
Castration-Resistant Prostate Carcinoma
Eligibility:
MALE
Brief 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 r...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the correlations between baseline molecular features and pathways and prostate-specific antigen (PSA) response (\</\>= 50% decline) at 12 weeks versus (vs.) baseline....
Eligibility Criteria
Inclusion
- 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 therapy prior to enrollment for flutamide and 6 weeks for bicalutamide and nilutamide without evidence of an anti-androgen withdrawal response; patients who NEVER HAD A PSA decline with the most recent anti-androgen therapy or in whom the response to the most recent anti-androgen was for \< 3 months require only a 2 week washout period prior to first dose of study drug
Exclusion
- Severe, concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment
- Metastases in the brain or active epidural disease (NOTE: patients with treated epidural disease are allowed)
- Platelet count \< 75,000/uL
- Prothrombin time (PT) or international normalized ratio (INR) and a partial thromboplastin time PTT \> 1.5 times the institutional upper limit of normal (ULN)
- Structurally unstable bone lesions suggesting impending fracture
- Previous treatment with MDV3100, ARN-509, or BMS-641988
- Medical contraindications to stopping aspirin, Coumadin or other anticoagulants for 1 week prior to image-guided tumor biopsies
- Plans to initiate treatment with an investigational agent while on study prior to discontinuation of MDV3100 treatment
- A second active malignancy except adequately treated non-melanoma skin cancer or other non-invasive or in situ neoplasm
Key Trial Info
Start Date :
March 12 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 27 2020
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT02228265
Start Date
March 12 2013
End Date
February 27 2020
Last Update
September 28 2020
Active Locations (3)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
2
UCSF Medical Center-Mount Zion
San Francisco, California, United States, 94115
3
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239