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NCT01875250 · ClinicalTrials.gov registry record · Phase 2
Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT01875250: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01875250 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01875250, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study Summary
Background: \- Enzalutamide is a well tolerated hormone therapy that is used to treat advanced prostate cancer. It is given to help kill cancer cells and limit cancer cell growth. A new possible way of treating prostate cancer is using a therapeutic cancer vaccine (immune stimulating therapy) that may help activate the immune system against the cancer. The immune stimulating vaccine will help white blood cells recognize and kill the cancer cells throughout the body. This vaccine therapy has been tested in hundreds of patients and is very well tolerated. 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. Key Eligibility: * Men at least 18 years of age who have advanced castration sensitive prostate cancer. * Patients must have testosterone within the normal range * No evidence of metastatic prostate cancer on computed tomography (CT) or Bone scan * No history of autoimmune diseases * No previous immunotherapy within 3 years 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 for 3 months. This form of intermittent therapy is common in this population of patients. * The vaccine group of participants will receive 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 injection during the third week of treatment, and one in the fifth week. The vaccine will
Primary Outcome
Growth rate was measured using the growth rate equation -f(t) = exp (-d\*t) + exp (g\*t) -1 where exp is the base of the natural algorithm, e = 2.7182 and t is days since treatment started. The tumor growth rate equation measures Prostate Specific Antigen (PSA) rise over time. The UOM is unitless because this is a way to measure PSA kinetics.
Interventions
- BIOLOGICAL PROSTVAC-F (Fowlpox)/TRICOM
- BIOLOGICAL PROSTVAC-V (Vaccinia)/TRICOM
- DRUG Enzalutamide (Xtandi)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2013-07-22 |
| Est. Completion | 2020-02-28 |
| Phase | Phase 2 |
What the finished NCT01875250 record still lists
NCT01875250 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 3 interventions - of which PROSTVAC-F (Fowlpox)/TRICOM is the first listed.
NCT01875250 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01875250 about?
NCT01875250 is a clinical study titled "Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer". Background: \- Enzalutamide is a well tolerated hormone therapy that is used to treat advanced prostate cancer. It is given to help kill cancer cells and limit cancer cell growth. A new possible way of treating prostate cancer is using a therapeutic cancer vaccine (immune stimulating therapy) that ...
What is the current status of trial NCT01875250?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2013-07-22. Estimated completion is 2020-02-28.
What interventions are being tested in trial NCT01875250?
The interventions under investigation include: PROSTVAC-F (Fowlpox)/TRICOM (BIOLOGICAL), PROSTVAC-V (Vaccinia)/TRICOM (BIOLOGICAL), Enzalutamide (Xtandi) (DRUG).
Who is sponsoring clinical trial NCT01875250?
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 NCT01875250's enrollment target sits among peer trials
38 1467th of 2000 higher than 517 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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