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Can an immune booster make hormone therapy work better against prostate cancer?

NCT ID NCT01688492

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

  • 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

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