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

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ClinicalTrials.gov Identifier: NCT03196388
Recruitment Status : Unknown
Verified January 2018 by Fundación Canaria de Investigación Sanitaria.
Recruitment status was:  Recruiting
First Posted : June 22, 2017
Last Update Posted : January 18, 2018
Hospital Universitario de Canarias
Information provided by (Responsible Party):
Fundación Canaria de Investigación Sanitaria

Brief 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

Condition or disease Intervention/treatment Phase
Prostate Carcinoma Drug: Enzalutamide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enzalutamide and External Beam Hypofractionated Radiotherapy For Intermediate Risk Localized Prostate Cancer
Actual Study Start Date : December 27, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Enzalutamide with External
On this study patients will be treated with 6 months of Xtandi (enzalutamide). Approximately one-third of the way through this treatment they will receive EBRT. Starting on Day 1, all patients will ingestenzalutamide 160 mg/day at the same time each day without breaks (except as outlined for toxicity), with or without food, for 6 (28 day +/-3 days) cycles. Dose reduction of enzalutamide to 120 mg/day is allowed with the approval of the Medical Monitor. Patients will be instructed to return all unused capsules at each study visit to assess compliance and will receive study drug every 28 days (+/-3 days) for 6 cycles (25 weeks).
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

Other Name: XTANDI

Primary Outcome Measures :
  1. Number of patients with more or equal 80% reduction of baseline PSA [ Time Frame: 25 week after treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Life expectancy of greater than 1 year.
  • Diagnosis of histologically confirmed prostate carcinoma
  • ECOG Score ≤ 1
  • Participants must have an adequate organic function, defined as:

    1. Leukocytes ≥3,000/mcL
    2. Platelets ≥80,000/mcL
    3. Total bilirubin < 2X institutional upper limit
    4. AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
    5. Creatinine < 2x institutional limits .
  • Potentially fertile patients should use effective contraceptive methods (barrier methods plus other contraceptive methods) before entering the study and during their participation in the study
  • Ability to understand and the willingness to sign a written informed consent
  • Patients should be available for clinical follow-up.
  • To be able to swallow the medication of the study and to fulfill the requirements of the same one

Exclusion Criteria:

  • Received an investigational agent within 4 weeks prior to enrollment
  • Stage T4 prostate cancer by clinical examination or radiologic evaluation.
  • Hypogonadism or severe androgen deficiency as defined by screening serum testosterone less than 50 ng/dL below the normal range for the institution.
  • Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer.
  • Receiving concurrent androgens, anti-androgens, estrogens, or progestational agents, or received any of these agents within the 6 months prior to enrollment or having taken finasteride or dutasteride within 30 days of registration.
  • History of another active malignancy within the previous 5 years other than curatively treated nonmelanomatous skin cancer and superficial bladder cancer. Participants treated for malignancy with no relapse within two years are eligible to participate in the study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment.
  • History of seizure or any condition or concurrent medication that may predispose to seizure.
  • History of loss of consciousness or transient ischemic attack within 12 months prior to enrollment.
  • Clinically significant cardiovascular disease, including:

    1. Myocardial infarction within 6 months of enrollment
    2. Uncontrolled angina within 3 months of enrollment
    3. Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within 3 months results in a left ventricular ejection fraction ≥ 45%;
    4. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes);
    5. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place;
    6. Hypotension as indicated by systolic blood pressure < 86 mmHg on 2 consecutive measurements at the Screening visit;
    7. Bradycardia as indicated by a heart rate < 50 beats per minute at the Screening visit;
    8. Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg on 2 consecutive measurements at the screening visit;
    9. EKG demonstrating equal to or greater than grade III toxicity according the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
  • History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of oral study drug(s) within 3 months of enrollment.
  • Major surgery within 4 weeks of registration.
  • Previous use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-700, TAK-683, TAK-448) or targets the androgen receptor (e.g., enzalutamide, BMS 641988); ketoconazole.
  • Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, places the patient at undue risk, or complicates the interpretation of safety data.
  • Use of herbal or alternative remedies that may affect hormonal status such as Prostasol or PC-SPES.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196388

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Contact: Pedro Carlos Lara Jiménez, MD, PhD 00 34 928450284 pedrocarlos.lara@ulpgc.es
Contact: Vanessa Pacual Alfaro 00 34 928450259 vanepasal@hotmail.com

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Hospital Ramón y Cajal Recruiting
Madrid, Spain
Contact: Asuncion Hervas, MD         
Sponsors and Collaborators
Fundación Canaria de Investigación Sanitaria
Hospital Universitario de Canarias
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Principal Investigator: Pedro Carlos Lara Jiménez, MD, PhD Hospital Universitario de Gran Canaria Dr. Negrín
Additional Information:
Publications of Results:
Trump D. Commentary on: "Enzalutamide monotherapy in hormone-naive prostate cancer: primary analysis of an open-label, single-arm, phase 2 study." Tombal B, Borre M, Rathenborg P, Werbrouck P, Van Poppel H, Heidenreich A, Iversen P, Braeckman J, Heracek J, Baskin-Bey E, Ouatas T, Perabo F, Phung D, Hirmand M, Smith MR. Institut de Recherche Clinique, Universite Catholique de Louvain, Brussels, Belgium. Electronic address: bertrand.tombal@uclouvain.be. Aarhus University Hospital, Aarhus, Denmark. Herlev Hospital, Herlev, Denmark. AZ Groeninge Kortrijk, Kortrijk, Belgium. UZ Leuven, Leuven, Belgium. Klinik und Poliklinik fur Urologie, RWTH University Aachen, Aachen, Germany. Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. UZ Brussel, Brussels, Belgium. Univerzita Karlova v Praze, Prague, Czech Republic. Astellas Pharma Global Development, Leiden, Netherlands. Astellas Pharma Global Development, Northbrook, IL, USA. Medivation Inc, San Francisco, CA, USA. Massachusetts General Hospital Cancer Center, Boston, MA, USA: Lancet Oncol. 2014 May;15(6):592-600; doi: 10.1016/S1470-2045(14)70129-9. [Epub 2014 Apr 14]. Urol Oncol. 2016 May;34(5):248-9. doi: 10.1016/j.urolonc.2015.03.012. Epub 2015 Apr 30.

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Responsible Party: Fundación Canaria de Investigación Sanitaria
ClinicalTrials.gov Identifier: NCT03196388    
Other Study ID Numbers: 2015-004617-25
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación Canaria de Investigación Sanitaria:
External Beam Hypofractionated Radiotherapy Intermediate Risk Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases