Molecular Features and Pathways in Predicting Drug Resistance in Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Enzalutamide
Identifying Mechanisms of Resistance to Enzalutamide (MDV3100) Treatment in Men With Castration-Resistant Prostate Cancer
3 other identifiers
observational
41
1 country
3
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2013
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 2013
CompletedFirst Submitted
Initial submission to the registry
August 25, 2014
CompletedFirst Posted
Study publicly available on registry
August 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2020
CompletedSeptember 28, 2020
September 1, 2020
6.6 years
August 25, 2014
September 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
PSA response, a binary variable indicating whether the PSA level has declined >= 50% within 12 weeks of beginning enzalutamide treatment
Will be reported with 95% exact confidence interval.
Within 12 weeks
Secondary Outcomes (9)
Degree of PSA decline
12 weeks
Disease-specific survival
Time from day 1 of the study drug to date of death from prostate cancer, assessed up to 4 years
Maximal PSA decline observed while on study
Up to 4 years
Molecular features
Up to 4 years
Objective response
Up to 4 years
- +4 more secondary outcomes
Study Arms (1)
Ancillary-Correlative (genetic analysis)
Patients undergo collection of blood and tissue samples at baseline, during administration of enzalutamide and after the time of disease progression for analysis via immunohistochemistry, comparative genome hybridization, and sequencing.
Interventions
Undergo blood and tissue collection
Given PO
Eligibility Criteria
Patients with prostate cancer treated at Oregon Health and Science University Knight Cancer Institute
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OHSU Knight Cancer Institutelead
- United States Department of Defensecollaborator
- Oregon Health and Science Universitycollaborator
Study Sites (3)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
OHSU Knight Cancer Institute
Portland, Oregon, 97239, United States
Biospecimen
Tissue and blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshi Alumkal
OHSU Knight Cancer Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 25, 2014
First Posted
August 29, 2014
Study Start
March 12, 2013
Primary Completion
October 1, 2019
Study Completion
February 27, 2020
Last Updated
September 28, 2020
Record last verified: 2020-09