ZD4054 With Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) for Prostate Cancer - Full Text View

Purpose

The purpose of this research study is to assess the effects of ZD4054 on prostate cancer that has spread to the bones by using new imaging techniques. In particular, this study will use fluorodeoxyglucose (FDG) and 18F-Sodium Fluoride (NaF) PET/computed tomography (CT) and MRI scans to look for changes in bone metastasis after ZD4054 therapy.

Condition	Intervention	Phase
Prostate Cancer	Drug: ZD4054	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pharmacodynamic Response Assessment With PET/MRI Imaging in Patients With Metastatic Prostate CAncer to Bone Treated With ZD4054

Resource links provided by NLM:

MedlinePlus related topics: Cancer MRI Scans Nuclear Scans Prostate Cancer

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

The Number of Subjects Whose Tumor Lesion Size Changed After 6 Weeks of Treatment With ZD4054 Using PET and MRI Scans. [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Multimodal Positron Emission Tomography (PET) and Magnetic Resonant Imaging (MRI) imaging were used to evaluate changes in the tumor lesion size following 6 weeks of treatment with ZD4054.

Secondary Outcome Measures:

The Number of Subjects Whose Tumor Lesion Size Changed Using Positron Emission Tomography (PET) Imaging Alone. [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
The Number of Subjects Whose Tumor Lesion Size Changed Using Diffusion-weighted Imaging (DWI)-Magnetic Resonant Imaging (MRI) Alone [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Number of Subjects Whose Tumor Lesion Size Changed Using Iterative Decomposition of Water and Fat With Echo Asymmetry and Least-squares Estimation (IDEAL)-MRI Imaging Alone [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Number of Subjects With PSA Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	6
Study Start Date:	April 2010
Study Completion Date:	November 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 ZD4054 + multimodal PET/MRI imaging	Drug: ZD4054 All patients will be treated with ZD4054 at 10 mg PO daily, repeated in four week cycles (1 cycle = 28 days). All patients will initially undergo NaF and FDG PET/CT and MRI imaging at baseline (scan#1), and then again after 4 weeks (scan#2) of ZD4054 exposure. Subsequently, ZD4054 will be held for 2 weeks followed by the final NaF and FDG-PET/CT and MRI acquisition (scan#3). After the final PET/MRI is obtained, patients will resume ZD4054 and be assessed for safety prior to each new cycle of therapy. Standard disease evaluation assessments will be conducted after cycle#3, and repeated after every third cycle (sooner if clinically indicated). Therapy will continue until radiographical/clinical disease progression or unacceptable toxicity Other Name: ZD4054

Arms

Assigned Interventions

Experimental: 1

ZD4054 + multimodal PET/MRI imaging

Drug: ZD4054

All patients will be treated with ZD4054 at 10 mg PO daily, repeated in four week cycles (1 cycle = 28 days). All patients will initially undergo NaF and FDG PET/CT and MRI imaging at baseline (scan#1), and then again after 4 weeks (scan#2) of ZD4054 exposure. Subsequently, ZD4054 will be held for 2 weeks followed by the final NaF and FDG-PET/CT and MRI acquisition (scan#3). After the final PET/MRI is obtained, patients will resume ZD4054 and be assessed for safety prior to each new cycle of therapy. Standard disease evaluation assessments will be conducted after cycle#3, and repeated after every third cycle (sooner if clinically indicated). Therapy will continue until radiographical/clinical disease progression or unacceptable toxicity

Other Name: ZD4054

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men > 18 years of age.
Histologically proven adenocarcinoma of the prostate.
Presence of radiographic bone metastasis with at least one which is amenable to serial imaging using MRI/PET imaging.
Patients must have evidence of progressive disease by either radiographic progression or a rising PSA within 4 weeks prior to registration.
Patients must have had prior treatment with bilateral orchiectomy or other primary androgen-deprivation therapy.
For patients previously treated with flutamide (Eulexin), Nilutamide (Nilandron), or bicalutamide (Casodex): Patients must have discontinued flutamide > 4 weeks prior to registration with continued evidence of progressive disease. For bicalutamide or nilutamide, patients must have discontinued the drug > 6 weeks prior to registration with evidence of progressive disease.
Prior therapy is permitted as long as it was given > 4 weeks prior to registration, and evidence for disease progression is met.
Patients must not have had prior radiotherapy < 4 weeks prior to registration.
Prior use of bisphosphonates allowed only if started at least 12 or more weeks prior to registration (can continue current dose/schedule while on study).
Patient cannot have had prior Strontium 89, Samarium 153, or other radioisotope.
No concurrent use of estrogen, or estrogen-like agents
Patients must have adequate organ function
ECOG performance status 0-2.

Exclusion Criteria:

Use of potent CYP450 inducers (such as phenytoin, rifampicin, carbamazepine and phenobarbitone, St. John's Wort) within 2 weeks prior to start of study treatment.
Prior therapy with endothelin receptor antagonists or family history of hypersensitivity to endothelin antagonists.
History of past or current epilepsy, epilepsy syndrome, or other seizure disorder.
Stage II, III or IV cardiac failure (classified according to New York Heart Association (NYHA) classification), myocardial infarction within 6 months prior to study entry, or have left ventricular function (LVEF) below the institutional normal limit.
QT interval corrected for heart rate (by Bazett's correction) (QTcB) >470 msec.
Previous history or presence of another cancer, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last 5 years.
Major surgery within 6 weeks of registration.
Hemoglobin (Hb) <9 g/dL. Concomitant use of erythropoietin or blood transfusions is allowed.
Inability to take or absorb oral medications.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119118

Locations

United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

AstraZeneca

Investigators

Principal Investigator:

Glenn Liu, M.D.

University of Wisconsin, Madison

More Information

No publications provided

Responsible Party:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT01119118 History of Changes
Other Study ID Numbers:	CO09805
Study First Received:	May 5, 2010
Results First Received:	January 23, 2013
Last Updated:	March 18, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:

Metastatic
castrate-resistant prostate cancer
bone metastasis

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013