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COMPLETED
NCT02649855
PHASE2

Docetaxel and PROSTVAC for Metastatic Castration-Sensitive Prostate Cancer

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

Official title: Docetaxel and Prostvac for Metastatic Castration Sensitive Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2016-01-19

Completion Date

2023-12-05

Last Updated

2026-04-29

Healthy Volunteers

No

Interventions

BIOLOGICAL

PROSTVAC-V

It is a recombinant vaccinia virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 2x10(8) infectious units.

BIOLOGICAL

PROSTVAC-F

It is a recombinant fowlpox virus vector vaccine containing the genes for human prostate-specific antigen (PSA) and three co-stimulatory molecules (cluster of differentiation 80 (B7.1), intercellular adhesion molecule 1 (ICAM-1), and lymphocyte function-associated antigen 3 (LFA-3). It will be given subcutaneously, 1x10(9) infectious units.

DRUG

Docetaxel

It is commercially available. It will be administered at 75 mg/m(2) intravenously.

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States