Docetaxel and PROSTVAC for Metastatic Castration-Sensitive Prostate Cancer
Status:
Active, not recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
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 CT, 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.