No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Study type
Observational
Participants needed
120 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for
This trial is looking for men with metastatic castration-resistant prostate cancer. Participants will have their blood samples taken to help scientists understand how certain biomarkers may predict response to hormonal therapies.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with prostate adenocarcinoma.
I have evidence of metastatic disease.
I have had disease progression on a potent AR inhibitor.
I plan to start therapy with enzalutamide or abiraterone in the next 6 weeks.
I have low testosterone levels.
I have rising PSA levels.
I am over 18 years old.
I can provide informed consent.
You may not be able to join if
I have another active cancer.
I do not want to be followed for CTC biomarker studies.
My life expectancy is less than 6 months.
I will be receiving radiation or systemic therapies other than ADT.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 tu…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Patients will be eligible for inclusion in this study only if all of the following criteria apply:
1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Patients with pure small cell/neuroendocrine tumors of the prostate are not permitted.
2. Radiographic evi…
Inclusion Criteria:
Patients will be eligible for inclusion in this study only if all of the following criteria apply:
1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Patients with pure small cell/neuroendocrine tumors of the prostate are not permitted.
2. Radiographic evidence of metastatic disease by CT, MRI, or PET imaging.
3. Prior documented disease progression on one potent AR inhibitor (darolutamide, abiraterone, enzalutamide, or apalutamide or combinations of these) in any disease setting (mHSPC, nmCRPC, mCRPC) based on sequential PSA rises or radiographic progression.
4. Planned therapy with either standard of care enzalutamide and/or abiraterone acetate or another potent AR inhibitor (darolutamide, apalutamide if available) within the coming 6 weeks
5. Castrate levels of testosterone (\<50 ng/dl) at most recent assessment and/or documented ongoing Androgen Deprivation Therapy.
6. Evidence of disease progression based on a rising PSA on or following most recent therapy as evidenced by the following:
1. Consecutive PSA rises at least 2 weeks apart
2. Minimum PSA of 1.0 ng/dl prior to entry
7. Age \> 18 years.
8. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
A patient will not be eligible for inclusion in this study if any of the following criteria apply:
1. History of intercurrent or past medical or psychiatric illness including active stage IV malignancy that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
2. Unwillingness to be followed longitudinally for serial CTC biomarker studies.
3. Life expectancy \< 6 months
4. Planned combination therapy with radiation or other systemic therapies other than ADT and bone health agents.
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