MedTrace Logo

Docetaxel and PROSTVAC for Metastatic Castration-Sensitive Prostate Cancer

NCT02649855 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-04-29

Study results available
· View outcomes & findings →

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.

Conditions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Melissa Abel, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-19
Primary Completion
2022-07-01
Completion
2023-12-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02649855 on ClinicalTrials.gov