NCT03196388

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Fundación Canaria de Investigación Sanitaria · Academic / Other
• Sex: Male
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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

Detailed description

The participant will be given a study drug-dosing diary for each of 6 treatment cycles. Each treatment cycle lasts 28 days (4 weeks), during which time the participant will be taking the study drug enzalutamide by mouth (4 pills daily). The diary will also include special instructions for taking the enzalutamide. The participant will also be undergoing external beam radiation therapy during the study, for a duration of 5,5 weeks. Treatment will be administered on an outpatient basis. This part of the study is considered standard of care. The participant will be required to have IGRT either by ConeBeam CT study and/or fiducial markers placed within the prostate as part of this study. These are very small gold markers that are placed in the prostate. This procedure is similar to the biopsy that the participant had to diagnose their cancer. These both procedures are routinely performed to permit imaging and position corrections to improve the precision of the external beam (radiation) delivery (Image Guided Radiation Therapy). This is also considered standard of care and is not experimental. Planned Follow-up: Participants will be followed on study at a 3 month follow-up after treatment (cessation of enzalutamide). Additional follow-up to assess the status of the participant's cancer will be conducted at the discretion of the treating physicians as part of the participant's routine medical care.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-12-27
• Primary completion: 2018-06-01
• Completion: 2018-12-01
• First posted: 2017-06-22
• Last updated: 2018-01-18

Locations

1 site across 1 country: Spain