Blood test may predict prostate cancer drug response, avoiding painful biopsies
NCT ID NCT01961843
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether a blood test could predict how prostate cancer responds to the drug abiraterone. Instead of taking a tissue sample (biopsy), researchers measured tumor cells circulating in the blood of 40 men with advanced prostate cancer. The goal was to see if changes in these cells could help doctors know if the treatment is working, without needing invasive procedures.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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40 people
The number who actually took part.
- Start date
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Jan 2014
- Finished
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May 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Able to swallow the study drug whole as a tablet * Willing to take abiraterone on an empty stomach * Willing to use a method of birth control with adequate barrier protection * Metastatic disease as documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT, MRI * Asymptomatic or mildly symptomatic from prostate cancer * Surgically or medically castrated * Previous anti-androgen therapy and progression after withdrawal * Life expectancy of at least 6 months Exclusion Criteria: * Active infection or other medical condition that would make corticosteroid use contraindicated * Uncontrolled hypertension * Severe hepatic impairment * History of pituitary or adrenal dysfunction * Clinically significant heart disease as evidenced by myocardial infarction or arterial thrombotic events in the past 6 months, severe or unstable angina, or NYHA Class III or IV heart disease * Have any condition that, in the opinion of the investigator, would compromise the well being of the subject or the study or prevent the subject from meeting or performing study requirements * Have poorly controlled diabetes * Have a history of gastrointestinal disorders that may interfere with the absorption of the study agents * Have a pre-existing condition that warrants long-term corticosteroid use in excess of study dose * Have known allergies, hypersensitivity or intolerance to abiraterone acetate or prednisone or their excipients * Pathologic finding consistent with small cell carcinoma of the prostate * Liver, visceral organ or brain metastasis * Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC * Radiation therapy for treatment of the primary tumor within 6 weeks of Cycle 1, Day 1 * Radiation or radionuclide therapy for treatment of metastatic CRPC tumor within 2 or 6 weeks, respectively, of Cycle 1, Day 1 * Previous treatment with ketoconazole for prostate cancer for greater than 7 days * Prior systemic treatment with an azole drug * Prior flutamide treatment within 4 weeks of Cycle 1, Day 1 * Bicalutamide, nilutamide within 6 weeks of Cycle 1, Day 1 * Active or symptomatic viral hepatitis or chronic liver disease * History of a different malignancy except for the following circumstances: disease-free for at least 5 years and deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: basal cell or squamous cell carcinoma of the skin * Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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