New combo therapy may delay prostate cancer's return
NCT ID NCT01786265
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This study tests whether adding abiraterone and prednisone to standard hormone therapy works better than hormone therapy alone for men whose prostate cancer has come back after surgery or radiation. About 310 men will receive either hormone therapy or hormone therapy plus abiraterone and prednisone. The goal is to see which approach keeps PSA levels low for longer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 310 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2013
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- 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: * Have signed an informed consent document indicating that the subjects understand the purpose of and procedures required for the study and are willing to participate in the study * Written Authorization for Use and Release of Health and Research Study Information has been obtained * Be willing/able to adhere to the prohibitions and restrictions specified in this protocol * Life expectancy \>= 12 months * ECOG performance status (PS) =\< 2 * Histologically documented diagnosis of adenocarcinoma of the prostate (PCa) with no histologic variants * Prostate cancer recurrence after definitive local therapy (radical prostatectomy and/or radiation therapy) as evidenced by rising serum PSA, without evidence of metastases by bone scan or computed tomography (CT) scan * After radiation: A rising PSA taken to indicate recurrent prostate cancer in patients with previous definitive external beam radiotherapy will be defined as PSA of 1.0 * After Radical Prostatectomy: A rising PSA taken to indicate recurrent prostate cancer in patients with previous radical prostatectomy will be defined by the criteria of the American Urological Association as any PSA measurement of 0.2, with a subsequent measurement \> 0.2 ng/mL * Patients who have received androgen ablative therapy for less than 8 weeks immediately prior to initiation of study drug are eligible provided they had only PSA evidence of progression (as defined above) with no visible metastases by CT-scan and bone scan (within 6 weeks) prior to starting androgen ablation * White blood cell (WBC) \>= 3.5 x 10\^9/L * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L * Platelets \>= 100 x 10\^9/L * Hemoglobin (Hb) \>= 9.0 g/dL * Total bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 1.5 x the upper limit of normal * Serum potassium of \>= 3.5 mEq/L * Serum albumin of \>= 3.0 g/dL * Serum creatinine =\< 1.5 x ULN * Patients must have recovered from prior treatment regimens, e.g. surgery, radiation * A patient who is sexually active and their partner must agree and use two reliable barrier forms of contraception (for example, condoms and diaphragm), from first day of study drug administration until for 1 week after last dose of abiraterone acetate, unless partner is post-menopausal * Able to swallow the study drug whole as a tablet * Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken Exclusion Criteria: * Patients who have received prior hormonal therapy are excluded from the trial, except for: patients who have received up to 6 months of hormonal therapy as neoadjuvant therapy before radical prostatectomy or while on radiation therapy, as long as more than 1 year has elapsed between discontinuation of the neoadjuvant hormonal therapy and initiation of hormonal treatment for relapsing disease * Any known metastases * Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\>= 450 msec) * Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \< 50% at baseline * Significant co-morbidity that could affect the safety or evaluability of participants as assessed by the treating physician and or principal investigator * Prior therapy with strontium-89, samarium, rhenium-186 etidronate, chemotherapy or androgen biosynthesis inhibitors for prostate cancer is not allowed. Previous immunologic, homeopathic, natural, or alternative medicine therapies are acceptable provided treatment ended greater than 28 days prior to initiation of study drug * Patients who, in the opinion of the investigator, are unable to comply with the requirements of the study protocol are not eligible * Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated * Active or symptomatic viral hepatitis * History of pituitary or adrenal dysfunction * Administration of an investigational therapeutic drug within 30 days of cycle 1 day 1 * Have known allergies, hypersensitivity, or intolerance to abiraterone acetate or prednisone or their excipients * Have a history of gastrointestinal disorders (medical disorders or extensive surgery) 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
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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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M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a One-Two radiation punch improve prostate cancer control?
- Can a special PET scan change the course of prostate cancer?
- Can a High-Tech radiation beam hit prostate tumors without harming healthy tissue?
- Can 3D imaging make prostate radiation more precise and worth the cost?