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

Pfizer

Status and phase

Completed

Phase 2

Conditions

Prostate Carcinoma Metastatic to the Bone

Castration Resistant Prostate Cancer

Treatments

Drug: Enzalutamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02384382

MDV3100-18

C3431012 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 μg/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.