Enzalutamide and External Beam Hypofractionated Radiotherapy For Intermediate Risk Localized Prostate Cancer (ENZART)
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| ClinicalTrials.gov Identifier: NCT03196388 |
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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
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Carcinoma | Drug: Enzalutamide | Phase 2 |
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.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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).
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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 |
- Number of patients with more or equal 80% reduction of baseline PSA [ Time Frame: 25 week after treatment ]
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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
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Participants must have an adequate organic function, defined as:
- Leukocytes ≥3,000/mcL
- Platelets ≥80,000/mcL
- Total bilirubin < 2X institutional upper limit
- AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
- 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.
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Clinically significant cardiovascular disease, including:
- Myocardial infarction within 6 months of enrollment
- Uncontrolled angina within 3 months of enrollment
- 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%;
- History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes);
- History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place;
- Hypotension as indicated by systolic blood pressure < 86 mmHg on 2 consecutive measurements at the Screening visit;
- Bradycardia as indicated by a heart rate < 50 beats per minute at the Screening visit;
- Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg on 2 consecutive measurements at the screening visit;
- 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.
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
| Contact: Pedro Carlos Lara Jiménez, MD, PhD | 00 34 928450284 | pedrocarlos.lara@ulpgc.es | |
| Contact: Vanessa Pacual Alfaro | 00 34 928450259 | vanepasal@hotmail.com |
| Spain | |
| Hospital Ramón y Cajal | Recruiting |
| Madrid, Spain | |
| Contact: Asuncion Hervas, MD | |
| Principal Investigator: | Pedro Carlos Lara Jiménez, MD, PhD | Hospital Universitario de Gran Canaria Dr. Negrín |
Publications of Results:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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ENZALUTAMIDE External Beam Hypofractionated Radiotherapy Intermediate Risk Prostate Cancer |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases |