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Enzalutamide and External Beam Hypofractionated Radiotherapy For Intermediate Risk Localized Prostate Cancer

NCT03196388 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-01-18

No results posted yet for this study

Summary

This research study is evaluating a drug called enzalutamide in combination with external beam radiation therapy as a possible treatment for prostate cancer. Presently, when participants receive hormonal therapy with radiation therapy for prostate cancer, medications are given to reduce testosterone levels in the blood stream. This leads to side effects such as loss of sex drive, erectile dysfunction (ED) and decrease in muscle strength. The purpose of this study is test another form of hormonal therapy with radiationtherapy. The medication called enzalutamide will be used with radiation therapy. Instead of lowering testosterone, enzalutamide blocks testosterone in cells. This study will test if enzalutamide when used with radiation will lower the PSA without causing the side effects associated with medications that lower testosterone in the blood stream

Conditions

  • Prostate Carcinoma

Interventions

DRUG

Enzalutamide

Radiation: External Beam Radiation Dose will be normalized such that exactly 98% of the PTV (planned target volume) receives the prescription dose and will be scored as per protocol. The maximum allowable dose within the PTV is 107% of the prescribed dose to a volume that is at least 0.03 cc. The minimum allowable dose within the PTV is \>95% of the prescribed dose to a volume that is at least 0.03 cc. EBRT shall receive prescription doses to the PTV 70 Gy delivered in 2.5 Gy

Sponsors & Collaborators

  • Hospital Universitario de Canarias

    collaborator OTHER

  • Fundación Canaria de Investigación Sanitaria

    lead OTHER

Principal Investigators

  • Pedro Carlos Lara Jiménez, MD, PhD · Hospital Universitario de Gran Canaria Dr. Negrín

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-27
Primary Completion
2018-06-30
Completion
2018-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT03196388 on ClinicalTrials.gov