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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01119118
Recruitment Status : Terminated
First Posted : May 7, 2010
Results First Posted : April 29, 2013
Last Update Posted : April 29, 2013
Information provided by (Responsible Party):
University of Wisconsin, Madison

May 5, 2010
May 7, 2010
January 23, 2013
April 29, 2013
April 29, 2013
April 2010
August 2011   (Final data collection date for primary outcome measure)
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 ]
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.
To evaluate in identified target lesions a change in imaging parameters compared to baseline, after ZD4054 therapy, using multimodal PET/MRI imaging [ Time Frame: 6 months ]
Complete list of historical versions of study NCT01119118 on Archive Site
  • The Number of Subjects Whose Tumor Lesion Size Changed Using Positron Emission Tomography (PET) Imaging Alone. [ Time Frame: Week 6 ]
  • The Number of Subjects Whose Tumor Lesion Size Changed Using Diffusion-weighted Imaging (DWI)-Magnetic Resonant Imaging (MRI) Alone [ Time Frame: Week 6 ]
  • 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 ]
  • Number of Subjects With PSA Response [ Time Frame: 6 months ]
  • To document response to ZD4054 therapy with PET imaging alone (NaF and FDG-PET). [ Time Frame: 6 months ]
  • To document response to ZD4054 therapy with DWI-MRI imaging alone [ Time Frame: 6 months ]
  • To document response to ZD4054 therapy with IDEAL-MRI imaging alone [ Time Frame: 6 months ]
  • To correlate PSA response rate, changes in PSA velocity and PSA doubling time of subjects receiving ZD4054 to PET, MRI and combined PET/MRI imaging results [ Time Frame: 6 months ]
Not Provided
Not Provided
ZD4054 With Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) for Prostate Cancer
Pharmacodynamic Response Assessment With PET/MRI Imaging in Patients With Metastatic Prostate CAncer to Bone Treated With ZD4054
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.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
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
Experimental: 1
ZD4054 + multimodal PET/MRI imaging
Intervention: Drug: ZD4054
Simoncic U, Perlman S, Liu G, Staab MJ, Straus JE, Jeraj R. Comparison of NaF and FDG PET/CT for assessment of treatment response in castration-resistant prostate cancers with osseous metastases. Clin Genitourin Cancer. 2015 Feb;13(1):e7-e17. doi: 10.1016/j.clgc.2014.07.001. Epub 2014 Jul 15.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2011
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Men > 18 years of age.
  2. Histologically proven adenocarcinoma of the prostate.
  3. Presence of radiographic bone metastasis with at least one which is amenable to serial imaging using MRI/PET imaging.
  4. Patients must have evidence of progressive disease by either radiographic progression or a rising PSA within 4 weeks prior to registration.
  5. Patients must have had prior treatment with bilateral orchiectomy or other primary androgen-deprivation therapy.
  6. 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.
  7. Prior therapy is permitted as long as it was given > 4 weeks prior to registration, and evidence for disease progression is met.
  8. Patients must not have had prior radiotherapy < 4 weeks prior to registration.
  9. 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).
  10. Patient cannot have had prior Strontium 89, Samarium 153, or other radioisotope.
  11. No concurrent use of estrogen, or estrogen-like agents
  12. Patients must have adequate organ function
  13. ECOG performance status 0-2.

Exclusion Criteria:

  1. 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.
  2. Prior therapy with endothelin receptor antagonists or family history of hypersensitivity to endothelin antagonists.
  3. History of past or current epilepsy, epilepsy syndrome, or other seizure disorder.
  4. 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.
  5. QT interval corrected for heart rate (by Bazett's correction) (QTcB) >470 msec.
  6. 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.
  7. Major surgery within 6 weeks of registration.
  8. Hemoglobin (Hb) <9 g/dL. Concomitant use of erythropoietin or blood transfusions is allowed.
  9. Inability to take or absorb oral medications.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Principal Investigator: Glenn Liu, M.D. University of Wisconsin, Madison
University of Wisconsin, Madison
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP