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NCT01867333 · ClinicalTrials.gov registry record · Phase 2

Enzalutamide With or Without Vaccine Therapy for Advanced Prostate Cancer

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
57
Enrollment target

NCT01867333: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT01867333 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01867333, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
57 participants
Enrollment target

Study Summary

Background: \- Enzalutamide is a hormone therapy that is used to treat advanced prostate cancer. It is given after chemotherapy and surgery to help the body destroy the cancer cells. A new possible way of treating prostate cancer is using a vaccine that may help stimulate the immune system. It will help white blood cells recognize and kill the cancer cells in and around the prostate. Researchers want to see whether this vaccine, given with enzalutamide, is more effective at treating advanced prostate cancer than enzalutamide alone. Objectives: \- To compare the safety and effectiveness of enzalutamide with and without vaccine therapy for advanced prostate cancer. Eligibility: \- Men at least 18 years of age who have advanced castration-resistant prostate cancer. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies will be used to monitor the cancer before treatment. * Participants will be separated into two groups. One group will have enzalutamide and the study vaccine. The other group will have enzalutamide alone. * All participants will take enzalutamide once a day. They will take the drug during 4-week cycles of treatment. * Treatment will be monitored with frequent blood tests and imaging studies. Participants will continue to take the study drug for as long as the cancer does not grow, and the side effects are not severe. * The vaccine group of participants will also have the new study vaccine. They will have a single injection on the first day of the first study cycle. There will be regular booster injections afterward. There will be one on day 15 of the first cycle, the first day of the second cycle. The vaccine will then be given every 4 weeks for the next four cycles, and then every 12 weeks (every 3 cycles) thereafter. Participants will continue to have the study vaccine for as long as the cancer does not grow, and the side effects are not severe.

Primary Outcome

Time to progression is defined as the duration of time from start of treatment to time of disease progression. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions can also be considered progression if

Interventions

  • BIOLOGICAL Enzalutamide
  • BIOLOGICAL PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -F/TRICOM
  • BIOLOGICAL PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2013-08-12
Est. Completion 2022-10-26
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01867333 record still lists

NCT01867333 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 3 interventions - of which Enzalutamide is the first listed.

NCT01867333 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01867333 about?

NCT01867333 is a clinical study titled "Enzalutamide With or Without Vaccine Therapy for Advanced Prostate Cancer". Background: \- Enzalutamide is a hormone therapy that is used to treat advanced prostate cancer. It is given after chemotherapy and surgery to help the body destroy the cancer cells. A new possible way of treating prostate cancer is using a vaccine that may help stimulate the immune system. It will...

What is the current status of trial NCT01867333?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2013-08-12. Estimated completion is 2022-10-26.

What interventions are being tested in trial NCT01867333?

The interventions under investigation include: Enzalutamide (BIOLOGICAL), PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -F/TRICOM (BIOLOGICAL), PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM (BIOLOGICAL).

Who is sponsoring clinical trial NCT01867333?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT01867333's enrollment target sits among peer trials

57 1141st of 2000 higher than 855 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01867333, the US trial registry maintained by the National Library of Medicine. NCT01867333 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.