Enzalutamide in Patients With High-risk Prostate Cancer

NCT01927627 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: CASE12812NCI-2013-01661
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see how long it takes for prostate cancer to come back in patients who have had surgery to remove their prostate gland (radical prostatectomy), while being treated with enzalutamide (formerly known as MDV3100). Enzalutamide is known as an androgen-receptor signaling inhibitor, which means that it blocks activity of the male hormone, testosterone. Most prostate cancers are dependent on testosterone for growth. In this study, patients will take enzalutamide after surgery to see if it keeps their cancer from coming back.

Conditions

Adenocarcinoma of the Prostate

Keywords

Prostate cancer; adenocarcinoma of the prostate; Enzalutamide

Outcome Measures

Primary Outcomes (1)

• To Evaluate the Clinical Efficacy of Enzalutamide

  Clinical efficacy is measured as time to disease progression defined by biochemical recurrence (BCR). BCR was defined as PSA ≥0.2ng/mL on 2 consecutive lab results or any PSA rise that resulted in subsequent therapy.

  2 years

Secondary Outcomes (1)

• Safety of Enzalutamide

  2 years

Other Outcomes (1)

• Impact of Enzalutamide on Circulating Tumor Cells (CTCs)

  2 years

Study Arms (1)

Enzalutamide

EXPERIMENTAL

Oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).

Drug: enzalutamide

Interventions

enzalutamide DRUG

oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).

Also known as: XTANDI, MDV3100

Enzalutamide

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign an informed consent form.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Histologically confirmed adenocarcinoma of the prostate.
• Patients must have undergone a Radical Prostatectomy (any surgical technique is permitted) within 3 months from study entry and have high-risk disease define by any of the following:
• Pathological stage T3a, T3b, T4 (any grade or iPSA)
• Gleason' sum ≥ 8 (any stage or iPSA)
• Initial Pre-operative PSA ≥ 20ng/mL (any GS or pT stage)
• Any stage/PSA/Gleason patients with a 35% or greater chance of biochemical failure at 5 years based on Kattan's nomogram http://nomograms.mskcc.org/Prostate/PostRadicalProstatectomy.
• Patients with Lymph node (LN) positive disease, regardless of iPSA, pT stage or GS provided their post-operative PSA 6-8 weeks after surgery is ≤ 0.4ng/mL. (Lymph node dissection is desired but not mandated)
• Able to swallow the study drug and comply with study requirements.
• Patients must have normal organ and marrow function as defined below:
• Testosterone ≥ 50 ng/dL per laboratory reference range
• Baseline Post-RP PSA ≤ 0.4
• Hemoglobin ≥ 10.0 g/dL independent of transfusion
• Absolute neutrophil count ≥1,500/mcL

You may not qualify if:

• Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment
• Prior radiotherapy to the prostate or pelvis (related to prostate cancer). Concurrent adjuvant radiation therapy is permitted once patient has been enrolled on trial.
• Prior use of Abiraterone acetate or cytotoxic chemotherapy for prostate cancer
• Prior androgen deprivation with Luteinizing hormone-releasing hormone (LHRH) is permitted provided that testosterone levels prior to study entry have recovered to normal limits per reference laboratory.
• No prior anti-androgen therapy (bicalutamide, flutamide or Nilutamide) is permitted
• Prior use of 5-alpha reductase inhibitors is permitted provided such medications were stopped 7-14 days prior to enrollment
• Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 2 weeks of enrollment
• Active unresolved infection
• Known history of central nervous system (CNS) metastases
• Patients must have no known history of HIV
• Evidence of metastatic disease as evidenced by a CT or MRI of abdomen and pelvis and/or whole body bone scan (WBS). To be done prior to treatment start and up to 4 months prior to radical prostatectomy date.
• History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma). Also, history of loss of consciousness or transient ischemic attack within 12 months of enrollment.
• Clinically significant cardiovascular disease including:
• Myocardial infarction within 6 months prior to Screening;
• Uncontrolled angina within 3 months prior to Screening;

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Jorge Garcia MD
• Organization: Case Comprehensive Cancer Cent

garciaj4@ccf.org

216-444-7774

Study Officials

• Jorge Garcia, MD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: August 22, 2013
• Study Start: November 11, 2013
• Primary Completion: March 29, 2017
• Study Completion: April 26, 2017
• Last Updated: March 20, 2019
• Results First Posted: March 12, 2019

Record last verified: 2019-03

Locations

US (1)