Radiologically Guided Biopsies of mCRPC
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|ClinicalTrials.gov Identifier: NCT02432001|
Recruitment Status : Active, not recruiting
First Posted : May 1, 2015
Last Update Posted : April 1, 2021
The purpose of this study is to better understand how cancer treatment may affect cancer cells. The research will involve genetic, molecular, cellular, and immunologic experiments using blood and tumor specimens. It is hoped that the information gained from these studies will lead to a greater understanding of castrate-resistant prostate cancer and potentially, improvements in cancer treatment.
This is a tissue collection protocol requiring image-guided biopsies of metastatic, castration-resistant prostate cancer (mCRPC). The investigators will focus on enrolling patients with metastatic CRPC who have progressed while receiving novel AR-targeted therapeutics such as abiraterone and enzalutamide. This population of patients was selected because resistance develops relatively rapidly following potent inhibitors of AR activity and the mechanisms of resistance have to be better understood. Without comprehensive analysis of mCRPC tumor, the investigators will never gain a full understanding of the biology driving resistance in human disease and developing rational co-targeting approaches will not be possible.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Procedure: Image-Guided Biopsies|
|Study Type :||Observational|
|Actual Enrollment :||256 participants|
|Official Title:||Radiologically Guided Biopsies of Metastatic Castration Resistant Prostate Cancer (mCRPC) to Identify Adaptive Mechanisms of Resistance|
|Actual Study Start Date :||February 22, 2013|
|Actual Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||January 1, 2022|
Image-guided biopsies will be performed at the Dream Team Site enrolling the patient. Lesions will be chosen based upon the strength of the evidence suggesting the presence of metastasis and with the goal of minimizing patient risk. Soft tissue lesions and lesions with documented radiologic progression should be prioritized for biopsy. If the Radiologist in charge of the procedure cannot identify a lesion amenable for biopsy, the patient will be considered a screening failure.
Procedure: Image-Guided Biopsies
- Proportion of mCRPC patients with high androgen receptor activity [ Time Frame: Up to 2 years ]Determined by a gene-expression-based signature for Androgen Receptor activity having a probability of >0.50
- Progression Free Survival [ Time Frame: Up to 2 years ]Measured from the start of therapy after the baseline biopsy until progression. Patients not progressing will be censored at the date of last clinical follow-up or date of last contact, respectively.
- Overall Survival [ Time Frame: Up to 2 years ]Measured from the start of therapy after the baseline biopsy until death. Patients not progressing or dying will be censored at the date of last clinical follow-up or date of last contact, respectively
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432001
|United States, California|
|University of California, Davis|
|Davis, California, United States, 95616|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90095|
|University of California|
|San Francisco, California, United States, 94143|
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|University of British Columbia|
|Principal Investigator:||Eric Small, MD||University of California, San Francisco|