Can an immune booster make hormone therapy work better against prostate cancer?
NCT ID NCT01688492
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This trial is testing whether adding an immunotherapy drug called ipilimumab to the standard hormone therapy of abiraterone plus prednisone can help men with advanced prostate cancer that has spread and no longer responds to hormone treatment. The study includes men aged 18 and older who have not yet had chemotherapy or immunotherapy. Participants receive the hormone therapy daily, and ipilimumab is given by infusion every three weeks for four doses. The goal is to see if the combination is safe and whether it can slow cancer progression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ipilimumab combined with abiraterone acetate and prednisone
- What this could lead to
- If the combination works, it could offer a new way to slow or shrink advanced prostate cancer that has stopped responding to standard hormone therapy.
- What could go wrong
- This is an early-phase trial with a small number of patients, so the benefits are uncertain. Combining these drugs may also increase side effects, including immune-related reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
-
Sep 2012
- Expected to finish
-
Sep 2026
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Male participants only
- Healthy volunteers
-
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: Chemotherapy- and immunotherapy-naïve patients with progressive metastatic CRPC are eligible. * Age 18 or older, and be willing and able to provide informed consent. * Histologically or cytologically confirmed adenocarcinoma of the prostate at either MSKCC or at the participating site. * Castrate serum testosterone level, ≤ 1.73 nmol/L (50 ng/dL), at the Screening visit. * Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy (ie, surgical or medical castration). * Metastatic disease on imaging (e.g., bone scan, CT, MRI). Patients whose disease spread is limited to regional pelvic lymph nodes are not eligible. If lymph node metastasis is the only evidence of metastasis, it must be ≥ 2 cm in diameter. * Progressive disease at study entry defined by PSA and/or radiographic criteria according to the PCWG2. * Karnofsky performance status of ≥80-100, and estimated life expectancy of ≥ 6 months. * Toxicities related to prior therapy must either have returned to ≤ Grade 1 or baseline or been deemed irreversible and in the opinion of the Investigator not worsened. * Able to swallow the study drug and comply with study requirements. Exclusion Criteria: * History of another malignancy within the previous 5 years other than nonmelanomatous skin cancer. * Absolute neutrophil count \< 1,500/μL, or platelet count \< 75,000/μL, or hemoglobin \< 5.6 mmol/L (9 g/dL) at the Screening visit. (NOTE: patients may not have received any growth factors within 7 days or blood transfusions within 28 days of the hematologic laboratory values obtained at the Screening visit). * Serum bilirubin ≥ 1.5 x ULN or for patients with Gilbert's disease, ≥3 mg/dL at the Screening visit; AST or ALT ≥ 2.5 x ULN, (for patients with known liver metastasis, AST or ALT ≤ 5 x ULN is allowed) at the Screening visit. * Creatinine \> 177 μmol/L (2 mg/dL), albumin \< 30 g/L (3.0 g/dL), potassium ≤ 3.5 mEq/L at the Screening visit. * Clinically significant cardiovascular disease including myocardial infarction within 6 months, uncontrolled angina within 3 months, congestive heart failure New York Heart Association (NYHA) class 3 or 4, uncontrolled hypertension as indicated by systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 95 mmHg at the Screening visit. * Major surgery or radiation therapy within 4 weeks of enrollment (Day 1 Visit). * Treatment with antiandrogens (eg, bicalutamide, flutamide, or nilutamide) within 4 weeks of enrollment (Day 1 visit). Concomitant therapy with any of the agents listed in Section 4.3.2 is prohibited. * History of progression of prostate cancer disease while receiving ketoconazole. Prior use or participation in a clinical trial of an investigational agent that blocks androgen synthesis (eg, abiraterone acetate, TAK-700, TAK-683, TAK-448), chemotherapy, or immunological agents (eg, immune modulators, cytokines, vaccines, or antibody-delivered chemotherapy). The use of denosumab for bone metastasis is permitted. * Known allergy to any of the compounds under investigation. * The patient has uncontrolled or significant medical condition other than cancer, that would prevent the participation in the study or make this protocol unreasonably hazardous, in the opinion of the investigator, including but not limited to: * Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[eg, Wegener's granulomatosis\]); motor neuropathy considered of autoimmune origin (eg, Guillain-Barre syndrome and myasthenia gravis). * Known or suspected brain metastasis, or untreated leptomeningeal disease. * Active infection or other medical condition that would make prednisone use contraindicated. * Active or symptomatic viral hepatitis or chronic liver disease.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic castration resistant prostate cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
-
Northwestern University
Evanston, Illinois, 60208, United States
-
Oregon Health & Science University
Portland, Oregon, 97239, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Training a Patient's own immune cells to fight advanced prostate cancer
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?