RANDOMIZED, DOUBLE-BLIND, PHASE 3 TRIAL TO COMPARE THE EFFICACY OF IPILIMUMAB VS PLACEBO IN ASYMPTOMATIC OR MINIMALLY SYMPTOMATIC PATIENTS WITH METASTATIC CHEMOTHERAPY-NAÏVE CASTRATION RESISTANT PROSTATE CANCER

Not Applicable

Completed

• Conditions: -C61 Malignant neoplasm of prostate; Malignant neoplasm of prostate; C61

• Registration Number: PER-048-10
• Lead Sponsor: BRISTOL MYERS SQUIBB COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-03
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 0

Inclusion Criteria

• The patient must be willing to give informed consent and have the ability to do so.
• histological or cytological onfirmation of prostate adenocarcinoma;
• Having been treated by orchiectomy or receiving an LH-RH analogue, and having a testosterone level <50 ng / dl;
• Metastatic disease determined by any one of the following modalities: CT, MRI, gammagraphy;
• friction during hormonal treatment. For the purpose of establishing eligibility,
• Anti-androgens (bicalutamide, flutamide, nilutamide) or inhibitors of adrenal androgen production (aminoglutetamide or ketoconazole) should be discontinued before starting study therapy.
• ECOG 0-1 functional status
• asymptomatic or minimally symptomatic status.
• Men> 18 years of age or with the minimum age to grant their consent according to local regulations.

Exclusion Criteria

• Sexually active fertile men who do not use an effective contraceptive method if their partner is a woman of childbearing age (MEF).
• Visceral metastases (in liver, lung or brain) are not allowed;
• Autoimmune disease; Patients with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn´s disease, are excluded from this study. Patients with a history of symptomatic disease (eg, rheumatoid arthritis, autoimmune thyroiditis (for example, Hashimoto´s disease), autoimmune hepatitis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis (for example, Wegener´s granulomatosis); Patients with motor neuropathy considered of autoimmune origin (eg, Guillain-Barre syndrome) are excluded from this study, patients with vitiligo are eligible to enter the study.
• Less than 1 year since the resolution of a toxicity ^ Grade 2 related to pelvic therapy (for example, radiation enteritis);
• Dementia, altered mental status or any psychiatric disorder that could impede the understanding or granting of informed consent or filling in questionnaires;
• A serious uncontrolled medical disorder that, in the opinion of the investigator, could prevent the patient from receiving protocol therapy,
• A previous active malignancy within the previous 3 years, except for focally curable tumors that apparently have been cured and do not need further therapy, such as basal or squamous cell skin tumors, superficial bladder cancer or breast carcinoma in if you
• Known infection with HIV, hepatitis B virus or hepatitis C virus.
• Inadequate hematological function, defined as an absolute neutrophil count (ANC) <1500 / mm ^ 3, a platelet count <100,000 / mm ^ 3 or a hemoglobin level <9 g / dl.
• Inadequate liver function, defined by a level of total bilirubin> 2.5 times the upper limit of the normal range G ^ SN), AST and ALT levels> 2.5 times the LSN or> 5 times the LSN if there is liver metastasis ;
• Inadequate renal function, defined by a serum creatinine level> 2.5 times the LSN;
• inadequate creatinine learance, defined as a value less than 50 ml / min;
• Previous treatment with any immunotherapy for prostate cancer, including the autologous vaccine against sipuleucel-T prostate cancer (Provenge);
• Previous or ongoing cytotoxic therapy for metastatic prostate cancer (for example, docetaxel, mitoxantrone, estramustine);
• pelvic adiotherapy within 3 months prior to the start of study therapy;
• Chronic use of immunosuppressants and / or systemic corticosteroids (used in the management of cancer or non-cancer related diseases). However, during the course of the study, the use of corticosteroids will be allowed if they are used to treat IAS or adrenal insufficiencies;
• Any therapy of non-cancer vaccines used for the prevention of infectious diseases (for up to 4 weeks before or after any dose of the study blind drug);
• Previous treatment with any inhibitor or agonist of costimulation of T cells;
• Previous therapy with radioisotopes (for example, strontium-89, samarium-153 or similar agents);
• Inmates or individuals who are held against their will;
• Individuals who are necessarily detained for the treatment of a psychiatric or physical illness (for example, for an infectious disease).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:OS was defined as the time from the date of randomization until the date of death. For participants without documentation of death, OS was censored at the last date the participant was known to be alive.<br><br>Measure:Overall Survival (OS) Time<br>Timepoints:Randomization until death from any cause, up to April 2015, approximately 57 months<br>