A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC)
NCT02384382
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
- 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).
- 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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| 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 |
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| Intervention ICMJE | Drug: Enzalutamide
Other Names:
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| Study Arms ICMJE | Experimental: Enzalutamide monotherapy
Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily Intervention: Drug: Enzalutamide | ||||||
| Publications * | Not Provided | ||||||
* 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 | 23 | ||||||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 |
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| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| 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 | |||||||