A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC)

NCT ID: NCT02384382

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-05-03

Brief Summary

The purpose of this study is to evaluate 18F-sodium fluoride positron-emission tomography / computed tomography (18F-NaF PET/CT) imaging as a method for determining treatment response in metastatic bone lesions in patients who are receiving enzalutamide for castration-resistant prostate cancer.

Conditions

Prostate Carcinoma Metastatic to the Bone; Castration Resistant Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enzalutamide monotherapy

Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily

Group Type: EXPERIMENTAL

Enzalutamide

Intervention Type: DRUG

Interventions

Enzalutamide

Intervention Type: DRUG

Other Intervention Names

MDV3100; Xtandi

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, or signet cell or small cell features;
• Presence of bone metastatic disease as assessed by at least two lesions on whole body metastable technetium-methylene diphosphonate (99mTc-MDP) bone scintigraphy;
• Throughout the study, ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (LHRH) analogue or prior bilateral orchiectomy (medical or surgical castration);
• Testosterone ≤ 1.73 nmol/L (≤ 50 ng/dL) at screening;
• Progressive disease on androgen deprivation therapy at screening defined as a minimum of two sequentially rising prostate-specific antigen (PSA) values (PSA1 < PSA2 < PSA3);
• The screening PSA (PSA3) must be ≥ 2 μg/L (≥ 2 ng/mL).

Exclusion Criteria

• Prior enzalutamide, abiraterone acetate, aminoglutethimide, ketoconazole, radium Ra 223 dichloride or other bone-targeting radionuclides, or cytotoxic chemotherapy in the CRPC setting for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo);
• Treatment with hormonal therapy (eg, androgen receptor inhibitors, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than LHRH analogue therapy) within 4 weeks before enrollment;
• Initiation of new treatment with denosumab, bisphosphonates, or systemic corticosteroids for treatment of prostate cancer within 4 weeks before enrollment;
• Use of an investigational agent within 4 weeks before the screening visit;
• Radiation therapy to bone within 4 weeks before enrollment;
• Use of opiate analgesics for prostate cancer pain within 4 weeks before enrollment;
• Screening 99mTc-MDP bone scintigraphy showing a superscan;
• Visceral (eg, lung, liver) metastatic disease. Adenopathy is allowed;
• Current or previously treated brain metastasis or active leptomeningeal disease;
• History of seizure any time in the past for any reason or any condition that may predispose to seizures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: collaborator

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Karmanos Cancer Institute

Detroit, Michigan, United States

Karmanos Cancer Institute Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Wimr Pet/Ct

Madison, Wisconsin, United States

UW Clinical Sciences Center

Madison, Wisconsin, United States

Countries

United States

References

Kyriakopoulos CE, Heath EI, Ferrari A, Sperger JM, Singh A, Perlman SB, Roth AR, Perk TG, Modelska K, Porcari A, Duggan W, Lang JM, Jeraj R, Liu G. Exploring Spatial-Temporal Changes in 18F-Sodium Fluoride PET/CT and Circulating Tumor Cells in Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide. J Clin Oncol. 2020 Nov 1;38(31):3662-3671. doi: 10.1200/JCO.20.00348. Epub 2020 Sep 8.

Reference Type: DERIVED

PMID: 32897830 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

C3431012

Identifier Type: OTHER

Identifier Source: secondary_id

MDV3100-18

Identifier Type: -

Identifier Source: org_study_id