An observational study in Prostate Cancer, Prostate Adenocarcinoma and Prostate Cancer Metastatic, sponsored by Duke University. Recruiting at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Duke University · Observational
This study will follow men with metastatic castration resistant prostate cancer throughout their standard of care treatment for their disease to determine if the presence of different genes or proteins can predict which patients respond to the cancer treatment they receive. As tumors grow and begin to spread, they may release cells into patients' bloodstream. These cells are called "circulating tumor cells", or CTCs. CTCs can be used to look for differences in "biomarkers" (genes or proteins that may change based on how a person is or is not responding to treatment). The purpose of this research study is to learn whether scientists can use biomarkers from CTCs to predict which tumors will respond to certain hormonal therapies. Participants will have blood collected and provide an archival sample from a previous tumor biopsy. The researchers will compare biomarkers from participants who responded well to treatment to those who responded poorly in order to answer the research question.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 120 is below the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population includes men with progressive metastatic castration resistant prostate cancer (mCRPC) as defined in the eligibility criteria listed below. Participants will enroll at one of three locations: Duke University, University of Wisconsin Madison and Memorial Sloan Kettering Cancer Center.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients will be eligible for inclusion in this study only if all of the following criteria apply:
Evidence of disease progression based on a rising PSA on or following most recent therapy as evidenced by the following:
Exclusion Criteria:
A patient will not be eligible for inclusion in this study if any of the following criteria apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Men with progressive metastatic castration resistant prostate cancer (mCRPC) and starting standard of care therapy with a second androgen receptor (AR) inhibitor (typically enzalutamide or abiraterone acetate) will have blood collected for circulating tumor cell (CTC) assessments and other research assessments at baseline, 12 weeks and upon disease progression.
Comparison of progression-free survival (PFS) between biomarker positive and negative participants
PFS which is defined as the time from date of study enrollment to radiographic or clinical progression or death. Radiographic progression will be defined by Prostate Cancer Working Group 3 (PCWG3) criteria for soft tissue and bone metastases and will not include PSA changes alone. Clinical progression will be defined as clinical deterioration requiring a change in therapy, such as a pathologic fracture or symptomatic skeletal event or pain progression in the absence of imaging progression.
Time frame: Through completion of participant participation, up to 3 years
Comparison of overall survival between biomarker positive and negative participants
Overall survival is defined as time from date of study enrollment to date of death or last contact.
Time frame: Through completion of participant participation, up to 3 years
Comparison of the proportion of participants that achieve a >50% PSA declines from baseline between biomarker positive and negative participants
PSA decline will be assessed per PCWG3
Time frame: Through completion of participant participation, up to 3 years
Comparison of soft tissue response between biomarker positive and negative participants
Soft tissue response will be assessed per RECIST 1.1.
Time frame: Through completion of participant participation, up to 3 years
Comparison of duration of therapy between biomarker positive and negative participants
Time from initiation to discontinuation of therapy
Time frame: Through discontinuation of current therapy, up to 3 years
Number of emergent molecular lesions in CTCs that consistently emerge during subsequent AR therapy progression in men with mCRPC
Time frame: At disease progression, up to 3 years
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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