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

NCT02384382 | Completed Phase 2 Results

• 2 other identifiers: MDV3100-18C3431012
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 5

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

Keywords

Cancer of the Prostate

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With at Least (>=) 1 Responding Bone Lesion Assessed by Total Sodium Fluoride (NaF) Standardized Uptake Value [SUVtotal] at Third 18F-NaF PET/CT Imaging (NaF-3) Schedule

  Bone lesion responded: if its change from baseline in SUVtotal is below limit of agreement (LOA, no specific value, based upon test/retest analysis using software). SUVtotal: total NaF uptake,indicated tumor burden across all bone lesions/in individual lesions reflecting bone-metastatic prostate cancer.NaF-3 performed on any of these: 1) prostate-specific antigen (PSA) progression(increase of \>=25% and absolute increase of \>=2.0 ng/mL above nadir); 2) bone progressive disease(PD)(appearance of \>=2 new lesions after screening assessed by technetium Tc 99m medronate \[99mTc-MDP\] bone scintigraphy); 3) soft tissue PD; 4) clinically relevant progression by investigator; 5) at 2 years without progression after treatment initiation. PD, RECIST1.1:\>=20% increase in sum of diameters of target lesions,(reference smallest sum on study, included baseline sum if that is smallest on study),relative increase of 20%,sum of diameters indicated absolute increase of \>=5mm, appearance of \>=1 new lesions.

  At NaF-3 schedule: at time of PSA, or radiographic(bone or soft tissue), or clinically relevant progression, or at 2years without progression after treatment initiation, whichever occurred first(From first dose of study drug up to maximum of 34.1 months)

Secondary Outcomes (1)

• Mean Heterogeneity of Response Across All Bone Lesions as Measured by Global Heterogeneity of NaF Standardized Uptake (SUVhetero) Score at Third 18F-NaF PET/CT Imaging (NaF-3) Schedule

  At NaF-3 schedule: at time of PSA, or radiographic(bone or soft tissue), or clinically relevant progression, or at 2years without progression after treatment initiation, whichever occurred first(From first dose of study drug up to maximum of 34.1 months)

Study Arms (1)

Enzalutamide monotherapy

EXPERIMENTAL

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

Drug: Enzalutamide

Interventions

Enzalutamide DRUG

Also known as: MDV3100, Xtandi

Enzalutamide monotherapy

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead
• Astellas Pharma Inc: collaborator
• Medivation LLC, a wholly owned subsidiary of Pfizer Inc.: collaborator

Study Sites (5)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Karmanos Cancer Institute Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Wimr Pet/Ct

Madison, Wisconsin, 53763, United States

Location

UW Clinical Sciences Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• 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.

  PMID: 32897830 DERIVED

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: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 10, 2015
• Study Start: November 30, 2015
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: May 5, 2020
• Results First Posted: May 5, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

US (5)