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NCT02023463 · ClinicalTrials.gov registry record · Phase 1
Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer
A Phase 1 study of Recurrent Prostate Cancer and Stage IV Prostate Cancer, sponsored by Thomas Jefferson University.
- Active
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT02023463: Active Phase 1 study of Recurrent Prostate Cancer and Stage IV Prostate Cancer, sponsored by Thomas Jefferson University.
NCT02023463 is a Phase 1 study of Recurrent Prostate Cancer and Stage IV Prostate Cancer that is active but no longer recruiting, run by Thomas Jefferson University. The registered enrollment target is 25 participants, below the 138-participant average among 21 other Recurrent Prostate Cancer trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02023463, a Phase 1 study of Recurrent Prostate Cancer and Stage IV Prostate Cancer, is active but no longer recruiting, sponsored by Thomas Jefferson University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best way to give enzalutamide, radiation therapy, and hormone therapy in treating patients with intermediate or high-risk prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as enzalutamide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. Giving enzalutamide, radiation therapy, and hormone therapy may be an effective treatment for prostate cancer.
Primary Outcome
An exact 2-sided binomial 90% confidence interval will be computed and reported. Toxicity will be monitored and if there is greater than 10% incidence of grade 3 or higher gastrointestinal (GI)/genitourinary (GU)/fatigue lasting more than 7 days despite optimal treatment, the trial will be re-evaluated.
Conditions Studied
Interventions
- DRUG Leuprolide acetate
- DRUG Enzalutamide
- RADIATION Radiation therapy
- DRUG Goserelin acetate
Study Locations (1)
Pennsylvania
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2014-04-02 |
| Est. Completion | 2040-01-01 |
| Phase | Phase 1 |
What the registry record for NCT02023463 still lists
NCT02023463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 138-participant average among 21 other Recurrent Prostate Cancer trials with a reported enrollment target (82% lower).
The record links to 5 conditions, with Recurrent Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Leuprolide acetate is the first listed.
NCT02023463 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02023463 about?
NCT02023463 is a clinical study titled "Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer". This phase I trial studies the side effects and best way to give enzalutamide, radiation therapy, and hormone therapy in treating patients with intermediate or high-risk prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as enzalutamide, may lessen th...
What is the current status of trial NCT02023463?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2014-04-02. Estimated completion is 2040-01-01.
What conditions does trial NCT02023463 study?
This clinical trial studies the following conditions: Recurrent Prostate Cancer, Stage IV Prostate Cancer, Adenocarcinoma of the Prostate, Stage III Prostate Cancer, Stage IIB Prostate Cancer.
What interventions are being tested in trial NCT02023463?
The interventions under investigation include: Leuprolide acetate (DRUG), Enzalutamide (DRUG), Radiation therapy (RADIATION), Goserelin acetate (DRUG).
Who is sponsoring clinical trial NCT02023463?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02023463 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02023463's enrollment target sits among peer trials
25 15th of 21 higher than 7 of 21 other Recurrent Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Prostate Cancer 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.
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