Trial record 1 of 1 for:
Trial of Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate
Verified November 2016 by University of California, San Francisco
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Albert J. Chang, University of California, San Francisco
First received: July 23, 2015
Last updated: November 1, 2016
Last verified: November 2016
This is a phase II study to evaluate efficacy, safety, toxicity, and feasibility of the addition of enzalutamide to leuprolide for a total duration of 24 months in patients with very high-risk prostate cancer or pelvic node positive disease receiving radiotherapy. Very high-risk prostate cancer is defined as 2 or more of the following characteristics: 1) cT3a/b, 2) PSA ≥20 and <150, 3) Gleason 8-10, and 4) ≥33% core involvement.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Trial of Definitive Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate Cancer
Primary Outcome Measures:
Secondary Outcome Measures:
- Biochemical failure [ Time Frame: Up to 2 years ]
≥2 ng/mL from the nadir PSA per the Phoenix Definition
- Local progression [ Time Frame: Up to 2 years ]
Biopsy proven recurrence
- Regional progression [ Time Frame: Up to 2 years ]
Imaging or biopsy
- Distant progression [ Time Frame: Up to 2 years ]
Imaging or biopsy
- Time to clinical progression [ Time Frame: Up to 2 years ]
Date of PSA failure, local failure, regional or distant metastases
- Quality of life [ Time Frame: up to 2 years ]
Expanded Prostate Cancer Index Composite (EPIC), PROMIS, and EQ-5D
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2020 (Final data collection date for primary outcome measure)
Experimental: Single Arm
Enzalutamide: 160 mg (for 40 mg capsules) per day; Oral - swallow capsules hole, with or without food; Enzalutamide therapy to begin within 0-7 days of the date of the first Luteinizing Hormone-Releasing Hormone (LHRH) agonist administration for total duration of 24 months.
Leuprolide: any duration formulation: single 7.5mg injection every month; single 22.5 mg injection every 3 months; single 30mg injection every 4 months; single 45 mg injection every 6-months based on the manufacturer for a total of 24 months; Intramuscular injection
Other Name: Xtandi
Other Name: Lupron Depot
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days prior to registration at very high risk of recurrence as determined by 2 or more of the following combinations:
- PSA ≥20
- Gleason score 8-10
- ≥33% core involvement OR any patient with pelvic lymph node involvement ≥1cm as determined by pelvic CT or MRI imaging will meet eligibility criteria for enrollment.
- Standard staging exams for patients with high-risk prostate cancer including bone scan or NaF PET/CT scan, and pelvic and prostate MRI.
- No distant metastases (M0) on bone scan or NaF PET/CT within 90 days prior to registration. Equivocal bone scan findings are allowed if the physician determines that distant metastases are unlikely based on clinical judgment.
- Zubrod Performance Status 0-2 within 60 days prior to enrollment.
- Age ≥18
Complete blood count (CBC) with differential obtained within 30 days prior to registration on study, with adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) ≥1,800 cells/mm3
- Platelets ≥100,000 cells/mm3
- Hemoglobin ≥8.0 g/dl (The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable)
- Serum creatinine <2.0 mg/dl and creatinine clearance >40 mL/min within 30 days prior to registration
- Bilirubin <1.5 x ULN and Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) <2 × ULN within 21 days prior to registration
Patients, even if surgically sterilized (i.e., status post vasectomy), who:
- Agree to practice effective barrier contraception during the entire study treatment period and for 4 months (120 days) after the last dose of study drug, or
- Agree to completely abstain from intercourse
- Patient must be able to provide study-specific informed consent prior to study entry.
- Definite evidence of metastatic disease
- Prior radical prostatectomy or bilateral orchiectomy for any reason
- Prior invasive malignancy (except non-melanoma skin cancer) unless disease-free or not requiring systemic therapy for a minimum of 3 years.
- Prior systemic chemotherapy for prostate cancer (Note that prior chemotherapy for a different cancer is allowed).
- Prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields.
- Previous hormonal therapy such as LHRH agonists (e.g. goserelin, leuprolide), anti-androgens (e.g. flutamide, bicalutamide), estrogens (e.g. DES), or surgical castration (orchiectomy)
- Known hypersensitivity to enzalutamide or related compounds
- History of adrenal insufficiency
- Patients who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- Prior allergic reaction to the drugs involved in this protocol.
- Cushing's syndrome
- Severe chronic renal disease (serum creatinine >2.0 mg/dl and confirmed by creatinine clearance <40 mL/minute)
- Chronic liver disease (bilirubin >1.5x ULN, ALT or AST >2x ULN)
- Active/Uncontrolled Viral Hepatitis
- Chronic treatment with glucocorticoids within one year.
- History of seizure including febrile seizure or any condition that may predispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization). Also, current or prior treatment with antiepileptic medications for the treatment of seizures or history of loss of consciousness or transient ischemic attack within 12 months prior to randomization.
Clinically significant cardiovascular disease including:
- Myocardial infarction within 6 months prior to screening
- Uncontrolled angina within 3 months prior to screening
- Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 3 months results in a left ventricular ejection fraction that is ≥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;
- Uncontrolled hypertension as indicated by a resting systolic blood pressure >170 mm Hg or diastolic blood pressure >105 mm Hg at screening. Patients with initially elevated systolic blood pressure >170 mm Hg or diastolic blood pressure >105 mm Hg are eligible if they undergo medical management and are re-screened.
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02508636
University of California, San Francisco
National Comprehensive Cancer Network
||Albert J. Chang, Assistant Professor of Radiation Oncology, University of California, San Francisco
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 23, 2015
||November 1, 2016
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 24, 2017
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Fertility Agents, Female
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal