A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC)
Completed · Phase 2
Conditions studied: Prostate Carcinoma Metastatic to the Bone, Castration Resistant Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT02384382
- Run by
- Pfizer
- People needed
- 23
- Starts
- 2015-11-30
- Expected to finish
- 2019-05-03
- Last updated by the study team
- 2020-05-05
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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