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COMPLETED Phase 1

PLX3397, Radiation Therapy, and Antihormone Therapy in Treating Patients With Intermediate- or High-Risk Prostate Cancer

NCT02472275 · View on ClinicalTrials.gov ↗

Study Summary

This phase I trial studies the side effects and best dose of multitargeted tyrosine kinase inhibitor PLX3397 (PLX3397) when given together with radiation therapy and antihormone therapy in treating patients with prostate cancer that is at intermediate or high risk of spreading. Multitargeted tyrosine kinase inhibitor PLX3397 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may also help the radiation therapy work better. Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin acetate, or degarelix, may lessen the amount of androgens made by the body. Giving multitargeted tyrosine kinase inhibitor PLX3397 with radiation therapy and antihormone therapy may be a better treatment for prostate cancer.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • RADIATION Radiation Therapy
  • DRUG Antiandrogen Therapy
  • DRUG Multitargeted Tyrosine Kinase Inhibitor PLX3397

Study Locations (3)

Michigan

  • Wayne State University/Karmanos Cancer Institute — Detroit
  • Karmanos Cancer Institute at McLaren Northern Michigan - Petoskey Radiation Oncology — Petoskey
  • Karmanos Cancer Institute at McLaren Northern Michigan- Petoskey Medical Oncology — Petoskey

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2015-06
Est. Completion 2019-08-05
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02472275

The ClinicalTrials.gov registry entry for NCT02472275 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Barbara Ann Karmanos Cancer Institute, which has 97 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Stage II Prostate Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions — of which Laboratory Biomarker Analysis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02472275 reports 3 study locations spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02472275 about?

NCT02472275 is a clinical study titled "PLX3397, Radiation Therapy, and Antihormone Therapy in Treating Patients With Intermediate- or High-Risk Prostate Cancer". This phase I trial studies the side effects and best dose of multitargeted tyrosine kinase inhibitor PLX3397 (PLX3397) when given together with radiation therapy and antihormone therapy in treating patients with prostate cancer that is at intermediate or high risk of spreading. Multitargeted tyrosin...

What is the current status of trial NCT02472275?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2015-06. Estimated completion is 2019-08-05.

What conditions does trial NCT02472275 study?

This clinical trial studies the following conditions: Stage II Prostate Adenocarcinoma, Stage III Prostate Adenocarcinoma, Stage I Prostate Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02472275?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Radiation Therapy (RADIATION), Antiandrogen Therapy (DRUG), Multitargeted Tyrosine Kinase Inhibitor PLX3397 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02472275?

This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 97 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02472275 being conducted?

This trial has 3 study locations across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial