At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed prostate adenocarcinoma, stage >cT2cN0/M0 (with or without metastases, excluding CNS), or post-radical prostatectomy with rising PSA
- ✓PSA ≥4.0 ng/mL (Hybritech assay) at baseline or prior to hormone therapy initiation
- ✓ECOG performance status 0-2
- ✓Adequate organ function: WBC ≥3000/uL, platelets ≥75,000/uL, total bilirubin ≤1.5 mg/dL, transaminases ≤2.5× ULN, creatinine ≤2.0 mg/dL or creatinine clearance ≥60 mL/min
- ✕CNS metastases
- ✕Immune-suppressive diseases including AIDS, or autoimmune disorders such as multiple sclerosis, lupus, or myasthenia gravis
- ✕Prior hormonal therapy >21 days before enrollment (estrogens, LH/RH agonists, antiandrogens)
- ✕Recent immune-suppressive medication use within 3 months (steroids, Immuran, Cyclosporin; topical/inhalational steroids permitted)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Immunotherapeutic Trial: Combination Androgen Ablative Therapy and CTLA-4 Blockade as a Treatment for Advanced Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Bicalutamide, Flutamide, and 4 other interventions for Prostate Adenocarcinoma and 4 related conditions. Completed, enrolled 112 participants across 1 site.
Detailed Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
Study Details
Timeline
Interventions
Given orally
Given orally
Given SC
Given IV
Given IM
Correlative study