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Study of Everolimus Added to Combined Hormonal and Radiation Therapy for High Risk Prostate Cancer

NCT01642732 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-05-30

Study results available
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Summary

The purposes of this study are to:

* Determine the safest and highest dose of the study drug RAD001 (Everolimus) that can be taken in combination with hormonal and radiation therapy in men with high risk prostate cancer.
* Evaluate changes in patient reported quality of life
* Evaluate biomarkers from prostate tumor samples. Biomarkers are various traits which can be used to identify the progress of a disease or condition, which can help researchers determine the effect the study treatment has on the tumor. Biomarkers can also help determine areas for further research.

Conditions

Interventions

OTHER

Everolimus, lupron, bicalutamide, and radiation

Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1. Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks). Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy. Lupron injections will begin on study day 15 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections. Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study.

Sponsors & Collaborators

Principal Investigators

  • Daniel A. Hamstra, M.D., Ph.D. · University of Michigan Rogel Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT01642732 on ClinicalTrials.gov