Docetaxel Followed by Provenge in Metastatic Prostate Cancer (NCT02793765) | Clinical Trial Compass
WithdrawnPhase 2
Docetaxel Followed by Provenge in Metastatic Prostate Cancer
Stopped: Dendreon was sold and new company decided not to fund study.
United States0Started 2016-12
Plain-language summary
This clinical study will evaluate the role of combination therapy of docetaxel followed by Provenge for patients with metastatic castration-resistant prostate cancer (CRPC, (prostate cancer that is resistant to medical or surgical treatments that lower testosterone). The purpose of this study is to look at the combination therapy of docetaxel followed by Provenge to correlate the immunological biomarkers with clinical results for therapy. Biomarkers are genes, proteins and other molecules that affect how cancer cells grow, multiply, die and respond to other compounds in the body. The study drugs are approved by the Food and Drug Administration (FDA).
Treatment will be administered on an outpatient basis. Patients will receive 6 cycles of docetaxel followed by Provenge. Docetaxel is an antineoplastic (chemotherapy that affects cancer cell growth) agent. Docetaxel dose of 75 mg/m2 will be given intravenously as a 1-hour infusion every 21 days on Day 1 for 6 cycles. Provenge is an immunotherapy (vaccine made from patient's own blood cells) that reprograms immune cells to attack cancer. A course of therapy consists of three doses of Provenge administered at 2-week intervals.
The strategy aims to determine whether cytokine production and T cell infiltration of tumor cells could favor regression using a combination of chemotherapy plus vaccine. Tissue endpoints will include biopsies prior to first chemotherapy and first vaccine therapy and at the end of each therapy. Prostate cancer tissue infiltrates will be studied for expression of CD3, CD4, CD8, CD25/FOX3P, CD56, CTLA-4, PD-1, and Ki67. Additional immunological endpoints will be secondary antigen spread and various cytokine biomarkers.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. White blood cells ≥4000/mm3
. Absolute neutrophil count ≥1500/mm3
. Absolute lymphocyte count ≥500/µl
. Hemoglobin ≥10 g/dl
. Platelet count ≥100,000/mm3
Exclusion criteria
. Symptomatic congestive heart failure
. Unstable angina pectoris
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cytokine activity
Timeframe: 18 months
2
T-cell Proliferation
Timeframe: 18 months
3
Serum Levels
Timeframe: 18 months
4
Tissue Infiltration
Timeframe: 18 months
5
Secondary antigen Spread
Timeframe: 18 months
Trial details
NCT IDNCT02793765
SponsorThe University of Texas Health Science Center, Houston
. Uncontrolled hypertension \>150/100mm Hg (if controlled with medication this is not an exclusion).
. Hypotension
. Myocardial infarct or ventricular arrhythmia or stroke within a 6-month period prior to inclusion, ejection fraction (EF) \<40%, or serious cardiac conduction system disorders
. Patient is exhibiting evidence of symptomatic congestive heart failure, pulmonary embolus, vascular thrombosis, transient ischemic attack, cerebrovascular accident, unstable angina, myocardial infarction or active ischemia if a pacemaker is not present on electrocardiogram (ECG). An ECG must be performed at screening unless the subject has measurable disease in which case an ECG taken prior to screening but within 28 days of start of treatment will be accepted.