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

Last updated on March 31, 2018

FOR MORE INFORMATION
Study Location
Karmanos Cancer Institute
Detroit, Michigan, 48201 United States
Contact
1-800-718-1021
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 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.

NCT02384382
Pfizer
Active, not recruiting
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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Pfizer Clinical Trials Contact Center

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[email protected]

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A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC)
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
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.
Not Provided
Interventional
Phase 2
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Prostate Carcinoma Metastatic to the Bone
  • Castration Resistant Prostate Cancer
Drug: Enzalutamide
Other Names:
  • MDV3100
  • Xtandi
Experimental: Enzalutamide monotherapy
Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily
Intervention: Drug: Enzalutamide
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
23
March 2019
December 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02384382
MDV3100-18
C3431012 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
  • Astellas Pharma Inc
  • Medivation, Inc.
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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