Docetaxel and PROSTVAC for Metastatic Castration-Sensitive Prostate Cancer (NCT02649855) | Clinical Trial Compass
CompletedPhase 2
Docetaxel and PROSTVAC for Metastatic Castration-Sensitive Prostate Cancer
United States74 participantsStarted 2016-01-19
Plain-language summary
Background:
Metastatic castrate-sensitive prostate cancer is cancer that has spread beyond the prostate area. It can be controlled by lowering the amount of testosterone in the body. This is called androgen deprivation therapy (ADT). The vaccine PROSTVAC might help the immune system kill cancer cells. Researchers want to add PROSTVAC and docetaxel chemotherapy to ADT. They think this may work better against prostate cancer than ADT alone.
Objective:
To test if adding PROSTVAC and docetaxel to ADT works better against prostate cancer than ADT alone.
Eligibility:
Men ages 18 years and over with metastatic castrate-sensitive prostate cancer
Design:
Participants will be screened with:
Physical exam
Medical history
Blood tests
Possible computed tomography (CT), magnetic resonance imaging (MRI), or bone scan: Participants lie in a machine. The machine takes pictures of the body.
Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals.
Participants will have 2 optional tumor biopsies during the study.
Participants will join 1 of 2 groups. Both groups will get:
ADT
Docetaxel by vein
Steroids by mouth or vein before each docetaxel infusion
PROSTVAC injection
Both groups first have ADT. One to 4 months after, they have:
Group A:
Docetaxel every 3 weeks for 6 cycles
PROSTVAC 3 weeks after the last infusion
Booster injections 2 weeks later and then every 3 weeks, for 6 boosters total
Group B:
PROSTVAC
Booster 2 weeks later
Docetaxel hours later
Docetaxel and the booster every 3 weeks for 6 cycles
Participants will have a visit 4-5 weeks after the last treatment. They will then have visits every 12 weeks.
Participants will be followed for up to 15 years. This includes physical exams every year for 5 years.
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:
* Documented histopathological confirmation of prostate cancer-from a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.
* Patients must have metastatic disease, defined as at least one lesion on bone scan or at least one lesion that are measurable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. (Patients who have metastatic disease by these criteria prior to ADT, but then have changes after androgen deprivation therapy (ADT) that diminish the size of these lesions or changes on bone scan are still eligible.)
* Patients must have a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) criteria
* Patients must have adequate bone marrow, hepatic, and renal function with:
* Absolute neutrophil count (ANC) greater than or equal to 1500/microL, without cerebrospinal fluid (CSF) support
* Platelets greater than or equal to 100,000/microL
* Aspartate aminotransferase (AST)/Serum glutamic-oxaloacetic transaminase (SGOT) less than or equal to 2.5 times upper limit of normal (ULN);
* Alanine aminotransferase (ALT)/Serum glutamic-pyruvic transaminase (SGPT) less than or equal to 2.5 times upper limit of normal (ULN);
* Total serum bilirubin less than or equal to 1.5 times upper limit of normal (ULN), OR in patients with Gilbert's syndrome, a total bilirubin less than or equal to 3.0)
* Serum albumin greater than or equal to 2.8 g/dL
* Lipase \< 2.0 times the upper limit of normal a…
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
Antigen Spreading (i.e., a Broader Immune Response) With Greater Associated Response Score Compared to Docetaxel Alone After 19 Weeks