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

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NCT02384382

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Study Location
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Carcinoma Metastatic to the Bone, Castration Resistant Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Prostate Carcinoma Metastatic to the Bone, Castration Resistant Prostate CancerA Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC)
NCT02384382
  1. Detroit, Michigan
  2. Farmington Hills, Michigan
  3. New Brunswick, New Jersey
  4. Madison, Wisconsin
  5. Madison, Wisconsin
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC)
Official Title  ICMJE A PHASE 2, OPEN-LABEL, SINGLE-ARM STUDY OF 18F-SODIUM FLUORIDE PET/CT BONE IMAGING IN ENZALUTAMIDE-TREATED CHEMOTHERAPY-NAÏVE PATIENTS WITH BONE-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Carcinoma Metastatic to the Bone
  • Castration Resistant Prostate Cancer
Intervention  ICMJE Drug: Enzalutamide
Other Names:
  • MDV3100
  • Xtandi
Study Arms  ICMJE Experimental: Enzalutamide monotherapy
Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily
Intervention: Drug: Enzalutamide
Publications * 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 (18)F-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2017)		23
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2015)		40
Actual Study Completion Date  ICMJE May 3, 2019
Actual Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ?g/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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02384382
Other Study ID Numbers  ICMJE MDV3100-18
C3431012 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE
  • Astellas Pharma Inc
  • Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Investigators  ICMJE
Study Director:Pfizer Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP