Trial record 1 of 1 for:    NCT02508636
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Trial of Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02508636
Recruitment Status : Active, not recruiting
First Posted : July 27, 2015
Last Update Posted : May 4, 2018
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Hao Nguyen, University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Pelvic Nodal Drug: Enzalutamide Drug: Leuprolide Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Definitive Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate Cancer
Study Start Date : August 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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

Drug: Enzalutamide
Other Name: Xtandi

Drug: Leuprolide
Other Name: Lupron Depot

Primary Outcome Measures :
  1. Rate of acute toxicity [ Time Frame: ≤ 90 days within the completion of radiotherapy ]
    Common Toxicity Criteria for Adverse Events (CTCAE v 4.0)

  2. Rate of late toxicity [ Time Frame: ≥ 91days within the completion of radiotherapy ]
    Common Toxicity Criteria for Adverse Events (CTCAE v 4.0)

  3. Prostate Specific Antigen-Complete Response (PSA-CR) Rate [ Time Frame: Up to 2 years ]
    PSA nadir ≤0.3

Secondary Outcome Measures :
  1. Biochemical failure [ Time Frame: Up to 2 years ]
    ≥2 ng/mL from the nadir PSA per the Phoenix Definition

  2. Local progression [ Time Frame: Up to 2 years ]
    Biopsy proven recurrence

  3. Regional progression [ Time Frame: Up to 2 years ]
    Imaging or biopsy

  4. Distant progression [ Time Frame: Up to 2 years ]
    Imaging or biopsy

  5. Time to clinical progression [ Time Frame: Up to 2 years ]
    Date of PSA failure, local failure, regional or distant metastases

  6. Quality of life [ Time Frame: up to 2 years ]
    Expanded Prostate Cancer Index Composite (EPIC), PROMIS, and EQ-5D

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

Inclusion Criteria:

  1. 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:

    • cT3a/b
    • 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.
  2. Standard staging exams for patients with high-risk prostate cancer including bone scan or NaF PET/CT scan, and pelvic and prostate MRI.
  3. 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.
  4. Zubrod Performance Status 0-2 within 60 days prior to enrollment.
  5. Age ≥18
  6. Complete blood count (CBC) with differential obtained within 30 days prior to registration on study, with adequate bone marrow function defined as follows:

    1. Absolute neutrophil count (ANC) ≥1,800 cells/mm3
    2. Platelets ≥100,000 cells/mm3
    3. Hemoglobin ≥8.0 g/dl (The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable)
    4. Serum creatinine <2.0 mg/dl and creatinine clearance >40 mL/min within 30 days prior to registration
    5. Bilirubin <1.5 x ULN and Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) <2 × ULN within 21 days prior to registration
  7. Patients, even if surgically sterilized (i.e., status post vasectomy), who:

    1. 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
    2. Agree to completely abstain from intercourse
  8. Patient must be able to provide study-specific informed consent prior to study entry.

Exclusion Criteria:

  1. Definite evidence of metastatic disease
  2. Prior radical prostatectomy or bilateral orchiectomy for any reason
  3. Prior invasive malignancy (except non-melanoma skin cancer) unless disease-free or not requiring systemic therapy for a minimum of 3 years.
  4. Prior systemic chemotherapy for prostate cancer (Note that prior chemotherapy for a different cancer is allowed).
  5. Prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields.
  6. 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)
  7. Known hypersensitivity to enzalutamide or related compounds
  8. History of adrenal insufficiency
  9. 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.
  10. Prior allergic reaction to the drugs involved in this protocol.
  11. Cushing's syndrome
  12. Severe chronic renal disease (serum creatinine >2.0 mg/dl and confirmed by creatinine clearance <40 mL/minute)
  13. Chronic liver disease (bilirubin >1.5x ULN, ALT or AST >2x ULN)
  14. Active/Uncontrolled Viral Hepatitis
  15. Chronic treatment with glucocorticoids within one year.
  16. 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.
  17. Clinically significant cardiovascular disease including:

    1. Myocardial infarction within 6 months prior to screening
    2. Uncontrolled angina within 3 months prior to screening
    3. 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%;
    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. 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.

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 identifier (NCT number): NCT02508636

United States, California
University of California San Francisco
San Francisco, California, United States, 94158
Sponsors and Collaborators
Hao Nguyen
National Comprehensive Cancer Network

Responsible Party: Hao Nguyen, MD, University of California, San Francisco Identifier: NCT02508636     History of Changes
Other Study ID Numbers: 15558
First Posted: July 27, 2015    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents